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Background & Aims: Perianal fistulation is a challenging phenotype of Crohn's disease, with significant impact on quality of life. Historically, fistulae have been classified anatomically in relation to the sphincter complex, and management guidelines have been generalized, with lack of attention to the clinical heterogenicity seen. The recent 'TOpClass classification system' for perianal fistulizing Crohn's disease (PFCD) addresses this issue, and classifies patients into defined groups, which provide a focus for fistula management that aligns with disease characteristics and patient goals. In this article, we discuss the clinical applicability of the TOpClass model and provide direction on its use in clinical practice., Methods: An international group of perianal clinicians participated in an expert consensus to define how the TOpClass system can be incorporated into real-life practice. This included gastroenterologists, inflammatory bowel disease surgeons, and radiologists specialized in PFCD. The process was informed by the multi-disciplinary team management of 8 high-volume fistula centres in North America, Europe, and Australia., Results: The process produced position statements to accompany the classification system and guide PFCD management. The statements range from the management of patients with quiescent perianal disease to those with severe PFCD requiring diverting-ostomy and/or proctectomy. The optimization of medical therapies, as well as the use of surgery, in fistula closure and symptom management is explored across each classification group., Conclusion: This article provides an overview of the system's use in clinical practice. It aims to enable clinicians to have a pragmatic and patient goal-centered approach to medical and surgical management options for individual patients with PFCD., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Efficacy of mesenchymal stem cells (MSCs) for treatment of acute respiratory distress syndrome (ARDS) suggests bioactive bone marrow MSC extracellular vesicles (BM-MSC EVs) may be effective. A patient with severe COVID-19 associated ARDS who was presumed to expire was treated with a BM-MSC EV preparation (14 doses over two months) as a rescue treatment for refractory COVID ARDS. Near complete reversal of lung inflammation and fibrosis (per computed tomography), near complete restoration of mobility, hospital discharge (3 months) with resumption of normal activities of daily living (one year) and return to work occurred. No adverse events occurred despite repeated dosing of investigational product, highlighting safety of this potential therapy for ARDS., Competing Interests: No conflict except the below. John Ransom reports a relationship with Direct Biologics that includes: employment. John Ransom reports a relationship with Vivreon Biosciences, LLC that includes: co-owner. John Ransom reports a relationship with Stabilux Biosciences, Inc: Investor and board member. Anastasiya Shulman reports a relationship with Direct Biologics that includes: employment. Vik Sengupta reports a relationship with Direct Biologics that includes: consulting. Amy L. Lightner reports a relationship with Direct Biologics that includes: employment as Medical Director. Amy Lightner reports a relationship with Boomerang Medical that includes: Consultant and Chief Medical Officer., (© 2024 The Authors. Published by Elsevier Ltd.)

Inflammatory bowel disease remains a difficult disease to effectively treat, especially fistulizing Crohn's disease. Perianal fistulas in the setting of Crohn's disease remain an area of unmet need with significant morbidity in this patient population. Up to one third of Crohn's patients will have perianal fistulizing disease and current medical and surgical interventions are of limited efficacy. Thus, most patients experience significant morbidity, narcotic use, and loss of employment and end up with multiple surgical interventions. Mesenchymal stem cells (MSCs) have shown efficacy in phase 3 clinical trials, but considerable infrastructure challenges make MSCs limited with regard to scalability in clinical practice. Extracellular vesicles, being derived from MSCs and capturing the secretome functionality of MSCs, offer similar physiological utility regarding mechanism, while also providing an off the shelf regenerative medicine product that could be widely used in daily clinical practice., (© 2024. The Author(s).)

Background & Aims: Perianal fistulizing Crohn's disease (PFCD)-associated anorectal and fistula cancers are rare but often devastating diagnoses. However, given the low incidence and consequent lack of data and clinical trials in the field, there is little to no guidance on screening and management of these cancers. To inform clinical practice, we developed consensus guidelines on PFCD-associated anorectal and fistula cancers by multidisciplinary experts from the international TOpClass consortium., Methods: We conducted a systematic review by standard methodology, using the Newcastle-Ottawa Scale quality assessment tool. We subsequently developed consensus statements using a Delphi consensus approach., Results: Of 561 articles identified, 110 were eligible, and 76 articles were included. The overall quality of evidence was low. The TOpClass consortium reached consensus on 6 structured statements addressing screening, risk assessment, and management of PFCD-associated anorectal and fistula cancers. Patients with long-standing (>10 years) PFCD should be considered at small but increased risk of developing perianal cancer, including squamous cell carcinoma of the anus and anorectal carcinoma. Risk factors for squamous cell carcinoma of the anus, notably human papilloma virus, should be considered. New, refractory, or progressive perianal symptoms should prompt evaluation for fistula cancer. There was no consensus on timing or frequency of screening in patients with asymptomatic perianal fistula. Multiple modalities may be required for diagnosis, including an examination under anesthesia with biopsy. Multidisciplinary team efforts were deemed central to the management of fistula cancers., Conclusions: Inflammatory bowel disease clinicians should be aware of the risk of PFCD-associated anorectal and fistula cancers in all patients with PFCD. The TOpClass consortium consensus statements outlined herein offer guidance in managing this challenging scenario., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: In 2019, the Food and Drug Administration issued a black box warning for increased risk of venous thromboembolism in patients with rheumatoid arthritis exposed to tofacitinib. There are limited data regarding postoperative venous thromboembolism risk in patients with ulcerative colitis exposed to tofacitinib., Objective: To assess whether preoperative exposure to tofacitinib is associated with increased odds of postoperative venous thromboembolism., Design: Retrospective review., Settings: Tertiary academic medical center., Patients: Consecutive patients exposed to tofacitinib within 4 weeks before total abdominal colectomy or total proctocolectomy, with or without ileostomy, from 2014 to 2021, matched 1:2 for tofacitinib exposure or no exposure., Intervention: Tofacitinib exposure versus no exposure., Main Outcome Measures: Ninety-day postoperative venous thromboembolism rate., Results: Forty-two patients with tofacitinib exposure and 84 case-matched patients without tofacitinib exposure underwent surgery for medically refractory ulcerative colitis. Nine (22.0%) tofacitinib-exposed patients and 7 (8.5%) unexposed patients were diagnosed with venous thromboembolism within 90 days of surgery. In univariate logistic regression, patients exposed to tofacitinib had 3.01 times increased odds of developing venous thromboembolism within 90 days after surgery compared to unexposed patients ( p = 0.04; 95% CI, 1.03-8.79). Other venous thromboembolism risk factors were not significantly associated with venous thromboembolisms. Venous thromboembolisms in both groups were most commonly portomesenteric vein thromboses (66.7% in the tofacitinib-exposed group and 42.9% in the unexposed group) and were diagnosed at a mean of 23.2 days (range, 3-90 days) postoperatively in the tofacitinib-exposed group and 7.9 days (1-19 days) in the unexposed group. There were no statistically significant differences in location or timing between the 2 groups., Limitations: Retrospective nature of the study and associated biases. Reliance on clinically diagnosed venous thromboembolisms may underreport the true incidence rate., Conclusions: Tofacitinib exposure before surgery for medically refractory ulcerative colitis is associated with 3 times increased odds of venous thromboembolism compared with patients without tofacitinib exposure. See Video Abstract ., Tofacitinib Se Asocia Con Un Mayor Riesgo De Tromboembolismo Venoso Postoperatorio En Pacientes Con Colitis Ulcerosa: ANTECEDENTES:En 2019, la FDA emitió una advertencia de recuadro negro sobre un mayor riesgo de tromboembolismo venoso en pacientes con artritis reumatoide expuestos a tofacitinib. Hay datos limitados sobre el riesgo de tromboembolismo venoso postoperatorio en pacientes con colitis ulcerosa expuestos a tofacitinib.OBJETIVO:Evaluar si la exposición preoperatoria a tofacitinib se asocia con mayores probabilidades de tromboembolismo venoso postoperatorio.DISEÑO:Revisión retrospectiva.LUGARES:Centro médico académico terciario.PACIENTES:Pacientes consecutivos expuestos a tofacitinib dentro de las 4 semanas previas a la colectomía abdominal total o proctocolectomía total, con o sin ileostomía, entre 2014 y 2021, emparejados 1:2 para exposición a tofacitinib o ninguna exposición.INTERVENCIÓN(S):Exposición a tofacitinib versus ninguna exposición.PRINCIPALES MEDIDAS DE RESULTADO:Tasa de tromboembolismo venoso posoperatorio a los 90 días.RESULTADOS:Cuarenta y dos pacientes con exposición a tofacitinib y 84 pacientes de casos similares sin exposición a tofacitinib se sometieron a cirugía por colitis ulcerosa médicamente refractaria. Nueve (22,0%) pacientes expuestos a tofacitinib y 7 (8,5%) pacientes no expuestos fueron diagnosticados con tromboembolismo venoso dentro de los 90 días posteriores a la cirugía. En la regresión logística univariada, los pacientes expuestos a tofacitinib tuvieron 3,01 veces más probabilidades de desarrollar un tromboembolismo venoso dentro de los 90 días posteriores a la cirugía en comparación con los no expuestos ( p = 0,04, IC del 95 %: 1,03-8,79). Otros factores de riesgo de tromboembolismo venoso no se asociaron significativamente con el tromboembolismo venoso. Los tromboembolismos venosos en ambos grupos fueron más comúnmente trombosis de la vena portomesentérica (66,7% en los expuestos a tofacitinib y 42,9% en los no expuestos) y se diagnosticaron en una media de 23,2 días (rango, 3-90 días) después de la operación en los expuestos a tofacitinib y 7,9 días. (1-19 días) en los grupos no expuestos, respectivamente. No hubo diferencias estadísticamente significativas en la ubicación o el momento entre los dos grupos.LIMITACIONES:Carácter retrospectivo del estudio y sesgos asociados. La dependencia de tromboembolismos venosos diagnosticados clínicamente puede subestimar la tasa de incidencia real.CONCLUSIONES:La exposición a tofacitinib antes de la cirugía para la colitis ulcerosa médicamente refractaria se asocia con probabilidades 3 veces mayores de tromboembolismo venoso en comparación con los pacientes sin exposición a tofacitinib. (Traducción-Dr. Mauricio Santamaria )., (Copyright © The ASCRS 2024.)

Several clinical trials are underway investigating cell and gene therapy, and while these trials are meant to significantly impact patient care, they rely on patient engagement and participation. Unfortunately, clinical trials generally require extensive commitment by subjects. While several studies are using validated surveys to measure patient-reported outcomes, there is a lack of characterization of the patient experience as a subject in these trials. As such, we surveyed mesenchymal stromal cell (MSC) trial participants to understand their perspective. We found that there exists a reliance on one's gastroenterologist and colorectal surgeons for trial introduction and that time and cost were the main barriers to participation. Overall, participants demonstrated high satisfaction with MSC trial participation, but future protocols could incorporate increased use of virtual appointments to optimize patient experience., Competing Interests: Declaration of interests A.L.L. is a consultant for Boomerang Medical., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Mesenchymal stem cells have been administered via direct injection to treat perianal Crohn's fistulizing disease. We herein sought to determine the safety and durability of treatment response to 12 months with 3 individual phase IB/IIA clinical trials of mesenchymal stem cells for refractory perianal, rectovaginal, and ileal pouch fistulas in the setting of Crohn disease., Methods: Three phase IB/IIA randomized placebo-controlled single-blinded clinical trials were performed for (1) perianal fistulas, (2) rectovaginal fistula, and (3) ileal pouch in situ with anovaginal and/or perianal fistulas. Bone marrow-derived mesenchymal stem cells (75 million in 7.5 mL) were injected at the time of exam under anesthesia on day 0 and month 3. Outcome measures were adverse events and combined clinical and pelvic magnetic resonance imaging healing at month 6 and month 12., Results: Across all 3 trials, 64 patients were enrolled; 49 were treatment and 15 were control. At 6 months, combined clinical and radiographic healing was achieved in 83.3%, 33.3%, and 30.8% of the perianal, rectovaginal, and pouch fistula treatment cohorts, respectively. At 12 months, the treatment response was durable, with 67.7% of perianal, 37.5% of rectovaginal, and 46.2% of peripouch fistulas maintaining complete clinical and radiographic healing. Two patients in the perianal fistula control cohort achieved combined clinical and radiographic healing at 12 months, whereas 0% of rectovaginal and pouch control patients healed., Conclusion: Bone marrow-derived mesenchymal stem cells offer a safe and effective alternative treatment approach for severe perianal, rectovaginal, and peripouch fistulizing Crohn's disease. Treatment results are durable at 12 months., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Solid abdominal organ transplantation is fraught with variable rates of rejection and graft versus host disease (GVHD). We sought to determine the safety and efficacy of an advanced extracellular vesicle (EV) investigational product (IP) derived from mesenchymal stem cells (MSC) in the transplant patient population. Seven separate emergency investigational new drug (eNIDs) were filed with the Food and Drug Administration (FDA) for the emergency treatment of rejection of an isolated intestinal graft ( n  = 2), liver allograft graft ( n  = 2), modified multivisceral graft ( n  = 3), and GVHD in isolated intestinal transplant patients ( n  = 2). Fifteen milliliters of IP was administered intravenously on Day 0, 2, 4, and this treatment cycle was repeated up to four times in each patient depending on the treatment protocol allowed by the FDA. Safety (adverse event reporting) and efficacy (clinical status, serologies, and histopathology) were evaluated. There were no adverse events related to IP. All patients had improvement in clinical symptoms within 24 h, improved serologic laboratory evaluation, improved pulmonary symptoms and dermatologic manifestations of GVHD, and complete histologic resolution of graft inflammation/rejection within 7 days of IP administration. Systemic use of a MSC-derived EV IP was successful in achieving histological clearance of intestinal, liver, and multivisceral graft inflammation, and skin and pulmonary manifestations of GVHD.

Background: Crohn-related rectovaginal fistulas are notoriously difficult to treat. Studies of mesenchymal stem cells for the treatment of perianal Crohn fistulizing disease have largely excluded rectovaginal fistulas. The aim of this study was to determine the safety and efficacy of mesenchymal stem cells for refractory rectovaginal fistulizing Crohn disease., Methods: A phase IB/IIA randomized control trial was performed in a 3:1, single-blinded study. Patients included were adult women with an anovaginal/rectovaginal fistula in the setting of Crohn disease. Seventy-five million mesenchymal stem cells were administered with a 22G needle after curettage and primary closure of the fistula tract at day 0 and month 3. Adverse and serious adverse events were recorded at post-procedure day 1, week 2, week 6, month 3, month 6, and month 12, along with clinical healing, magnetic resonance imaging, and patient-reported outcomes., Results: A total of 19 patients were enrolled and treated-15 treatment and 4 control. There were no adverse or serious adverse events related to mesenchymal stem cell therapy. At 6 months, 50% of the treatment group and 0% of the control had complete clinical and radiographic healing; 91.7% of the treatment group had improvement at 6 months with only one patient having a lack of response, whereas only 50% of the control group had improvement at 6 months., Conclusion: Bone marrow-derived mesenchymal stem cells offer a safe alternative treatment approach for rectovaginal fistulas in the setting of Crohn disease. Complete healing was achieved in half of the patients., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: Perianal disease occurs in up to 34% of inflammatory bowel disease (IBD) patients. An estimated 25% of women will become pregnant after the initial diagnosis, thus introducing the dilemma of whether mode of delivery affects perianal disease. The aim of our study was to analyze whether a cesarean section (C-section) or vaginal delivery influence perianal involvement. We hypothesized the delivery route would not alter post-partum perianal manifestations in the setting of previously healed perianal disease., Methods: All consecutive eligible IBD female patients between 1997 and 2022 who delivered were included. Prior perianal involvement, perianal flare after delivery and delivery method were noted., Results: We identified 190 patients with IBD who had a total of 322 deliveries; 169 (52%) were vaginal and 153 (48%) were by C-section. Nineteen women (10%) experienced 21/322 (6%) post-partum perianal flares. Independent predictors were previous abdominal surgery for IBD (OR, 2.7; 95% CI, 1-7.2; p = 0.042), ileocolonic involvement (OR, 3.3; 95% CI, 1.1-9.4; p = 0.030), previous perianal disease (OR, 22; 95% CI, 7-69; p < 0.001), active perianal disease (OR, 96; 95% CI, 21-446; p < 0.001) and biologic (OR, 4.4; 95% CI,1.4-13.6; p < 0.011) or antibiotic (OR, 19.6; 95% CI, 7-54; p < 0.001) treatment. Negative association was found for vaginal delivery (OR, 0.19; 95% CI, 0.06-0.61; p < 0.005). Number of post-partum flares was higher in the C-section group [17 (11%) vs. 4 (2%), p = 0.002]., Conclusions: Delivery by C-section section was not protective of ongoing perianal disease activity post-delivery, but should be recommended for women with active perianal involvement., (© 2024. The Author(s).)

Background: In this pilot safety study, we hypothesized that a human bone marrow stem cell-derived extracellular vesicle (hBM-MSC EV) investigational product (IP) would be safe and exhibit potential efficacy in amyotrophic lateral sclerosis (ALS) patients. Methods: Ten ALS patients received two 10-ml intravenous infusions of the IP given 1 month apart and evaluated over 3 months. Results: There were no serious adverse events or adverse events related to the IP and 30% of subjects' ALS functional rating scale-revised (ALSFRS-R) scores did not decline. Conclusion: HBM-MSC EVs appear safe in ALS patients. This early investigation suggests a controlled study of EVs for the treatment of ALS is warranted.

Aim: A 3-month pilot study to evaluate the safety of injecting a bone marrow-derived mesenchymal stem cell extracellular vesicle advanced investigational product (IP) into the lumbar facet joint space as a treatment for chronic low back pain. Methods: 20 healthy adults were treated with IP injections (0.5 ml/joint) and evaluated by three functional assessments 1, 3, 7, 14, 30, 60 and 90 days later. Results: No adverse effects or complications occurred across the 3-month follow-up. There were no reports of worsening pain. After 3 months group average scores improved significantly (p < 0.0001) in the Severity Index (65.04%), Interference Index (72.09%) and Oswestry Disability Index (58.43%) assessments. Conclusion: IP injections were safe and associated with significant functional improvements.

Background: Restorative proctocolectomy with IPAA is the surgical treatment of choice for patients requiring surgery for IBD and, less frequently, for other pathologies. Pouch prolapse is a rare complication that compromises pouch function and negatively affects patients' quality of life., Objective: This study aimed to describe our experience from a single high-volume center in this infrequent condition., Design: Restrospective cohort study of a prospectively maintained, Institutional Review Board-approved database., Settings: All consecutive eligible patients with IPAA and pouch prolapse were identified from 1990 to 2021., Patients: Patients with full-thickness prolapse treated by pouch pexy were included., Interventions: Pouch pexy (with/without mesh)., Main Outcome Measures: Success rate of pouch pexy, defined as no recurrence of prolapse., Results: A total of 4791 patients underwent IPAA; 7 (0.1%) were diagnosed with full-thickness prolapse. An additional 18 patients who underwent IPAA and had full-thickness prolapse were referred from outside institutions. Among 25 included patients, 16 (64.0%) were women, and the overall mean age was 35.6 ± 13.4 years. The time interval from initial pouch formation to prolapse was 4.2 (interquartile range, 1.1-8.5) years. Nine patients (36.0%) underwent previous treatment for prolapse. All patients presented with symptoms and physical examination compatible with full-thickness prolapse. Twenty patients (80.0%) underwent surgical pouch pexy without mesh and 5 (20.0%) had pouch pexy with mesh placement. A diverting ileostomy was performed in 1 patient (4.0%) before pouch pexy and in 8 patients (32.0%) at the time of surgical prolapse correction. After surgery, recurrent prolapse was noted in 3 patients (12.0%) at a median of 6.9 (interquartile range, 5.2-8.3) months., Limitations: Retrospective study, small sample size thus prone to selection, and referral biases, which may limit the generalizability of our findings., Conclusion: Pouch prolapse can be effectively treated with salvage surgery. Surgical intervention is safe and provides acceptable outcomes. See Video Abstract., Ciruga De Rescate Una Terapia Eficaz En El Manejo Del Prolapso De La Bolsa Ileoanal: ANTECEDENTES:La proctocolectomía restauradora con anastomosis reservorio ileoanal es el tratamiento quirúrgico de elección para aquellos pacientes que requieren cirugía por enfermedad inflamatoria intestinal y, con menor frecuencia, por otras patologías. El prolapso de la bolsa es una complicación rara que compromete la función de la bolsa y afecta de manera negativa la calidad de vida de los pacientes.OBJETIVO:Describir nuestra experiencia de un solo centro de alto volumen en esta condición poco frecuente.DISEÑO:Estudio de cohorte retrospectivo de una base de datos mantenida prospectivamente aprobada por el IRB.AJUSTES/PACIENTES:Fueron identificados y elegibles de manera consecutiva todos los pacientes con anastomosis de bolsa ileoanal y prolapso de bolsa entre 1990 y 2021. Se incluyeron pacientes con prolapso de bolsa de espesor total tratados con pexia.INTERVENCIONES:Pexia de la bolsa (con/sin malla).PRINCIPALES MEDIDAS DE RESULTADO:Tasa de éxito de la pexia de la bolsa, definida como ausencia de recurrencia del prolapso.RESULTADOS:Un total de 4.791 pacientes fueron sometidos a anastomosis de bolsa ileoanal; siete (0,1%) fueron diagnosticados con prolapso de espesor total. Otros 18 pacientes con anastomosis de reservorio ileoanal fueron derivados de instituciones externas. De entre los 25 pacientes incluidos, 16 (64,0 %) eran mujeres y la edad media promedio fue de 35,6+/-13,4 años. El intervalo de tiempo desde la creación inicial de la bolsa hasta el prolapso fue de 4,2 (IQR 1,1-8,5) años. Nueve (36,0 %) pacientes fueron sometidos a tratamiento previo para el prolapso (fisioterapia n = 4, pexia de la bolsa n = 2, pexia de la bolsa con malla n = 2, resección de la mucosa n = 1). Todos los pacientes presentaron síntomas y exploración física compatibles con prolapso de espesor total. Veinte (80,0%) pacientes se sometieron a pexia de bolsa quirúrgica sin malla y cinco (20,0%) se sometieron a pexia de bolsa con colocación de malla. Se realizó una ileostomía de derivación en un (4,0%) paciente antes de la pexia de la bolsa y en ocho (32,0%) pacientes en el momento de la corrección quirúrgica del prolapso. Posterior a la cirugía, se observó prolapso recurrente en tres pacientes (12,0 %) con una mediana de 6,9 (IQR 5,2-8,3) meses.LIMITACIONES:Estudio retrospectivo, pequeño tamaño de muestra, por lo tanto, propenso a sesgos de selección y referencia que pueden limitar la generalización de nuestros hallazgos.CONCLUSIÓN:El prolapso de la bolsa ileoanal puede tratarse de manera efectiva mediante la cirugía de rescate. La intervención quirúrgica es segura y proporciona resultados aceptables. (Traducción-Dr. Mauricio Santamaria )., (Copyright © The ASCRS 2023.)

Background: Perianal fistulizing Crohn's disease is notoriously difficult to treat. Recent studies of mesenchymal stem cells have demonstrated safety and efficacy of this novel treatment approach. However, no studies to date have included pediatric patients. We sought to determine safety and efficacy of mesenchymal stem cells for pediatric perianal fistulizing Crohn's disease., Methods: This was a phase I clinical trial to evaluate safety and feasibility of mesenchymal stem cells in pediatric perianal Crohn's patients 13 to 17 years of age. At the time of an exam under anesthesia, following curettage of the fistula tract and closure of the internal opening with absorbable suture, 75 million mesenchymal stem cells were administered with a 22-gauge needle. This was repeated at 3 months if complete clinical and radiographic healing were not achieved. Adverse and serious adverse events at were measured at postprocedure day 1, week 2, week 6, month 3, month 6, and month 12. Clinical healing, radiographic healing per magnetic resonance imaging, and patient-reported outcomes were measured at the same time points., Results: Seven pediatric patients were enrolled and treated (6 male; median age of 16.7 years). There were no adverse or serious adverse events related to the investigational product or injection procedure. At 6 months, 83% had complete clinical and radiographic healing. The perianal Crohn's Disease Activity Index, Wexner incontinence score, and Van Assche score had all decreased at 6 months., Conclusions: Bone marrow-derived mesenchymal stem cells offer a safe, and likely effective, treatment approach for pediatric perianal fistulizing Crohn's disease., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The leading cause of pouch failure following ileal pouch-anal anastomosis are peri-pouch fistulas and pelvic sepsis., Objective: Determine the overall efficacy of current surgical therapy for the treatment of perianal and anovaginal fistulizing disease related to Crohn's disease phenotype of the pouch., Design: Retrospective cohort study of a prospectively maintained, IRB-approved database., Settings/patients: Ninety-one (2.3%) patients of 3058 patients with an original diagnosis of ulcerative colitis who underwent proctocolectomy with ileal pouch-anal anastomosis between 2000 and 2021 at the Cleveland Clinic and underwent postoperative surgery for Crohn's-related perianal disease., Interventions: Two hundred thirty-one operations for perianal or anovaginal fistula(s)., Main Outcome and Measures: Healing rate of surgical therapy for peri-pouch fistulizing disease, impact of recurrent interventions on outcomes, and predictors of surgical failure., Results: Overall mean age was 39.1 (± 11.6) years, with a BMI of 25.3 (± 6.3) kg/m 2 . More than half of the patients were female (n = 52, 57.1%). Sixty-three patients (69.2%) had a perianal fistula, 25 (27.5%) had an anovaginal fistula, and 3 (3.3%) patients had both. Overall success rate for healing was 59.3% (n = 54/91) at a mean follow-up of 6.4 (± 4.8) years. Seventeen (18.7%) patients underwent a concomitant diverting loop ileostomy. Among them, eight (47.0%) patients had the ileostomy closure after a mean time of 9.7 (± 2.8) months. In the multivariable logistic regression model, patients who had seton insertions in any operation were significantly less likely to heal (OR 0.11 95%, CI 0.03-0.43, p = 0.001). Overall pouch failure rate was 12.1%., Limitations: Retrospective single-center study which lacks a control arm and consistent long-term follow-up specific to a population-based dataset., Conclusions: Pouch patients who develop perianal disease are difficult to treat, sometimes requiring pouch excision. However, when medical treatment alone is not effective, a multidisciplinary approach including surgical intervention can result in complete fistula healing in more than half of the cases., (© 2023. The Society for Surgery of the Alimentary Tract.)

Purpose: The safety of early ileostomy reversal after ileal pouch anal anastomosis (IPAA) has not been established. Our hypothesis was that ileostomy reversal before 8 weeks is associated with negative outcomes., Methods: This was a retrospective cohort study from a prospectively maintained institutional database. Patients who underwent primary IPAA with ileostomy reversal between 2000 and 2021 from a Pouch Registry were stratified on the basis of timing of reversal. Those reversed before 8 weeks (early) and those reversed from 8 weeks to 116 days (routine) were compared. The primary outcome was overall complications according to timing and reason for closure., Results: Ileostomy reversal was performed early in 92 patients and routinely in 1908. Median time to closure was 49 days in the early group and 93 days in the routine group. Reasons for early reversal were stoma-related morbidity in 43.3% (n = 39) and scheduled closure in 56.7% (n = 51). The complication rate in the early group was 17.4% versus 11% in the routine group (p = 0.085). When early patients were stratified according to reason for reversal, those reversed early for stoma-related morbidity had an increased complication rate compared to the routine group (25.6% vs. 11%, p = 0.006). Patients undergoing scheduled reversal in the early group did not have increased complications (11.8% vs. 11%, p = 0.9). There was a higher likelihood of pouch anastomotic leak when reversal was performed early for stoma complications compared to routinely (OR 5.13, 95% CI 1.01-16.57, p = 0.049)., Conclusions: Early closure is safe but could be delayed in stoma morbidity as patients may experience increased complications., (© 2023. Springer Nature Switzerland AG.)

Background: Bone marrow mesenchymal stem cell (BM-MSC)-derived extracellular vesicles (ExoFlo) convey the immunomodulatory and regenerative properties of intact BM-MSCs. This study aimed to determine the safety and efficacy of ExoFlo as treatment for moderate to severe ARDS in patients with severe COVID-19., Research Question: Do two doses of ExoFlo safely reduce mortality in COVID-19-associated moderate to severe ARDS compared with placebo?, Study Design and Methods: A prospective phase 2 multicenter double-anonymized randomized placebo-controlled dosing trial was conducted at five sites across the United States with infusions of placebo, 10 mL of ExoFlo, or 15 mL of ExoFlo on days 1 and 4. Patients (N = 102) with COVID-19-associated moderate to severe ARDS were enrolled and randomized to treatment. Adverse events were documented throughout the study. The primary outcome measure was all-cause 60-day mortality rate. Secondary outcomes included time to death (overall mortality); the incidence of treatment-emergent serious adverse events; proportion of discharged patients at 7, 30, and 60 days; time to hospital discharge; and ventilation-free days., Results: No treatment-related adverse events were reported. Mortality (60-day) in the intention-to-treat population was reduced with 15 mL ExoFlo mixed with 85 mL normal saline (ExoFlo-15) compared with placebo (not significant, χ 2 , P = .1343). For the post hoc subgroup analyses, 60-day mortality was decreased with ExoFlo-15 compared with placebo (relative risk, 0.385; 95% CI, 0.159-0.931; P = .0340; n = 50). With ExoFlo-15, a relative risk of 0.423 (95% CI, 0.173-1.032; P = .0588; n = 24) was determined for participants aged 18 to 65 years with moderate to severe ARDS. Ventilation-free days improved with ExoFlo-15 (P = .0455; n = 50) for all participants aged 18 to 65 years., Interpretation: The 15 mL dose of ExoFlo was found to be safe in patients with severe or critical COVID-19-associated respiratory failure. In participants aged 18 to 65 years, the risk reduction in 60-day mortality was further improved from subjects of all ages in the intention-to-treat population after two doses of 15 mL of ExoFlo compared with placebo., Clinical Trial Registration: ClinicalTrials.gov; No.: NCT04493242; URL: www., Clinicaltrials: gov., Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: A. L. L. is CMO at Direct Biologics. J. T. R. is a PhD at Direct Biologics. S. Q. and V. S. are prior associate CMOs at Direct Biologics. None declared (S. S., D. J. P., T. I. M., B. P. W., J. J. W., M. A.)., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Aim: Due to their rarity, the management of colorectal gastrointestinal stromal tumours (CR GISTs) is still under debate. The aim of this study was to assess prognostic factors., Method: We performed a retrospective review of patients who underwent surgery with curative intent for CR GIST at our centre from 2002 to 2019. Factors associated with overall (OS) and recurrence-free survival (RFS) were analysed., Results: Fifty-six patients were included [median age 63 years, 29 (52%) female, 30 (54%) Miettinen high-risk, 40 (71%) with rectal GIST]. Nineteen (34%) patients received perioperative (neoadjuvant and/or adjuvant) imatinib. All cases of colonic GIST had an R0 resection, compared with 28 (70%) of rectal GISTs. After a median follow-up of 97 months (interquartile range 48-155 months), 14 (25%) deaths and 14 (25%) recurrences occurred. In the high-risk cohort, factors associated with improved RFS were R0 resection (OR 0.19, 95% CI 0.1-0.5, p = 0.002) and perioperative imatinib (OR 0.33, 95% CI 0.42-0.97, p = 0.04). Patients who had received perioperative imatinib had longer RFS (60% vs. 11% at 5 years, p = 0.006) but not OS. In rectal GISTs, 5-year OS was 85% for R0 and 70% for R1 resections (p = 0.164) and 5-year RFS was 85% for R0 and 12% for R1 resection (p < 0.001). When stratifying patients by perioperative imatinib, there were no differences in OS or RFS in the R0 or R1 groups., Conclusion: Perioperative imatinib and R0 resection were associated with improved RFS in high-risk patients with CR GIST. In patients with rectal GIST, R1 resection was associated with worse RFS irrespective of perioperative imatinib treatment., (© 2023 Association of Coloproctology of Great Britain and Ireland.)

Background: Complex regional pain syndrome (CRPS) is an extremely painful disorder driven primarily by inflammation., Objectives: We hypothesized that the immunomodulatory biologic, ExoFloTM, composed of bone marrow mesenchymal stem cell-derived extracellular vesicles, could be safely administered to CRPS patients and alleviate symptoms., Study Design: Ten patients received 2 intravenous (IV) infusions, each containing 15 mL ExoFlo, on day one and day 4. A series of tests were performed at baseline (day 0, prior to infusion), week one, and months one, 3, and 6 after the second infusion., Setting: All patients were treated in one of 2 outpatient pain management clinics in Orange County, CA., Methods: Testing for clinical improvement included: visual analog scale of pain, brief pain inventory, 36-item short-form questionnaire, range of motion analysis, and jamar dynamometer testing., Results: No serious adverse events related to ExoFlo treatment occurred. Statistically significant improvements in pain and motion assessments occurred across the patient pool., Limitations: This study was limited by its patient number enrolled (10), it lacked a control arm, and one patient who dropped out of the study., Conclusions: IV delivery of ExoFlo appears safe in patients with CRPS. In addition, ExoFlo exhibited efficacy in addressing CRPS symptoms. Given the lack of effective and safe treatments available to CRPS patients, these results suggest that further studies are warranted to explore and validate this potential treatment for CRPS.

Background: Mesenchymal stem cells have been used for the treatment of perianal Crohn's fistulizing disease by direct injection. However, no studies to date have included patients with proctitis, anal canal involvement, and multiple branching tracts., Objective: This study aimed to determine safety and efficacy of mesenchymal stem cells for refractory perianal Crohn's disease., Design: Phase IB/IIA randomized controlled trial., Settings: Tertiary IBD referral center., Patients: Adult Crohn's disease patients with perianal fistulizing disease., Intervention: Seventy-five million mesenchymal stem cells were administered with a 22-G needle by direct injection after curettage and primary closure of the fistula tract. A repeat injection of 75 million mesenchymal stem cells at 3 months was given if complete clinical and radiographic healing were not achieved., Main Outcomes Measures: Adverse and serious adverse events occurred at postprocedure day 1, week 2, week 6, month 3, month 6, and month 12. Clinical healing, radiographic healing per MRI, and patient-reported outcomes were collected at the same time points., Results: A total of 23 patients were enrolled and treated; 18 were treatment patients and 5 were control. There were no adverse or serious adverse events reported related to mesenchymal stem cell therapy. At 6 months, 83% of the treatment group and 40% of the control group had complete clinical and radiographic healing. The perianal Crohn's disease activity index, Wexner incontinence score, and VanAssche score had all significantly decreased in treatment patients at 6 months; none significantly decreased in the control group., Limitations: Single institution and single blinded., Conclusions: Bone marrow-derived mesenchymal stem cells offer a safe and effective alternative treatment approach for severe perianal fistulizing Crohn's disease. See Video Abstract at http://links.lww.com/DCR/C128 ., Un Estudio De Fase Ib/iia De Clulas Madre Mesenquimales Derivadas De Mdula Sea Alognica Expandida Ex Vivo Para El Tratamiento De La Enfermedad De Crohn Fistulizante Perianal: ANTECEDENTES:Las células madre mesenquimales se han utilizado para el tratamiento de la enfermedad fistulizante de Crohn perianal mediante inyección dirigida. Sin embargo, ningún estudio hasta la fecha ha incluido pacientes con proctitis, afectación del canal anal y vías de ramificación múltiples.OBJETIVO:Determinar la seguridad y eficacia de las células madre mesenquimales para la enfermedad de Crohn perianal refractaria.DISEÑO:Ensayo de control aleatorizado de fase IB/IIA.AJUSTES:Centro de referencia de enfermedad inflamatoria intestinal terciaria.PACIENTES:Pacientes adultos con enfermedad de Crohn con enfermedad fistulizante perianal.INTERVENCIÓN:Se administraron 75 millones de células madre mesenquimales con una aguja 22G mediante inyección directa después del legrado y cierre primario del trayecto de la fístula. Se administró una inyección repetida de 75 millones de células madre mesenquimales a los 3 meses si no se lograba una curación clínica y radiográfica completa.PRINCIPALES MEDIDAS DE RESULTADOS:eventos adversos y adversos graves en el día 1, la semana 2, la semana 6, el mes 3, el mes 6 y el mes 12 después del procedimiento. Curación clínica, curación radiográfica por imagen de resonancia magnética y resultados informados por el paciente en los mismos puntos de tiempo.RESULTADOS:Un total de 23 pacientes fueron reclutados y tratados; 18 fueron de tratamiento y 5 de control. No se informaron eventos adversos o adversos graves relacionados con la terapia con células madre mesenquimales. A los seis meses, el 83 % del grupo de tratamiento y el 40 % del control tenían una curación clínica y radiográfica completa. El índice de actividad de la enfermedad de Crohn perianal, la puntuación de incontinencia de Wexner y la puntuación de VanAssche habían disminuido significativamente en los pacientes de tratamiento a los seis meses; ninguno disminuyó significativamente en el grupo de control.LIMITACIONES:Institución única y simple ciego.CONCLUSIONES:Las células madre mesenquimales derivadas de la médula ósea ofrecen un d tratamiento alternativo seguro y eficaz para la enfermedad de Crohn fistulizante perianal grave. Consulte Video Resumen en http://links.lww.com/DCR/C128 . (Traducción-Dr Yolanda Colorado )., (Copyright © The ASCRS 2023.)

Background: Redo ileocolic resection for recurrent Crohn's disease is associated with increased technical complexity and higher complication rates compared to primary resection. Literature concerning redo surgery for recurrent Crohn's disease is scarce and it is controversial whether a redo is a risk factor for postoperative anastomotic leak., Objective: This study aimed to hypothesized that redo ileocolic resection for Crohn's disease is an independent risk factor for anastomotic leak., Design: Retrospective, case-control study from 1994 to 2019 with multivariate analysis and propensity score weighting., Setting: Quaternary, IBD-referral center., Patients: Adult patients aged >18 years were included in the study., Interventions: Primary or redo ileocolic resection with an anastomosis, with or without diverting ileostomy., Main Outcome Measures: Thirty-day anastomotic leak rate., Results: A total of 991 patients (56% primary and 44% redo ileocolic resections) were included. Patients who underwent redo resection were significantly older with more comorbidities, fewer medications, and less fistulizing disease compared to the primary group. On univariate analysis, patients who underwent redo resection had more overall complications (50.5% vs 36.2%, p < 0.001), and the cumulative number of prior ileocolic resections was significantly associated with increased risk for overall morbidity ( p < 0.001). There were 31 (3%) anastomotic leaks; leak rates did not differ between groups ( p = 0.60). Multivariable analysis indicated that extensive adhesiolysis ( p < 0.001), ileostomy omission ( p = 0.009), and intraoperative abscess/fistula ( p = 0.02) were independently associated with leaks but not redo resection ( p = 0.27). Patients with 0, 1, 2, or 3 of these risk factors had observed leak rates of 1.1%, 1.3%, 6.0%, and 11.6.% ( p = 0.03), respectively., Limitations: The limitations of this study were selection bias, referral bias, and single quaternary center., Conclusions: Compared to primary procedures, redo ileocolic resection for recurrent Crohn's disease is associated with increased overall morbidity but not anastomotic leak. See Video Abstract at http://links.lww.com/DCR/C132 ., La Reseccin Ileoclica Rehecha No Es Un Factor De Riesgo Independiente De Fuga Anastomtica En La Enfermedad De Crohn Recurrente: ANTECEDENTES:La resección ileocólica para la enfermedad de Crohn recurrente se asocia con una mayor complejidad técnica y mayores tasas de complicaciones en comparación con la resección primaria. La literatura sobre la reintervención quirúrgica para la enfermedad de Crohn recurrente es escasa y es controvertido si una redo es un factor de riesgo para la fuga anastomótica posoperatoria.OBJETIVO:Tenemos la hipótesis de que rehacer la resección ileocólica para la enfermedad de Crohn es un factor de riesgo independiente para la fuga anastomótica.DISEÑO:Estudio retrospectivo de casos y controles de 1994 a 2019 con análisis multivariado y ponderación de puntuación de propensión.AJUSTE:Centro de referencia de enfermedad inflamatoria intestinal de cuarto nivel.PACIENTES:Pacientes adultos >18 años.INTERVENCIONES:Resección ileocólica primaria o rehecha con una anastomosis, con o sin derivación de ileostomía.PRINCIPALES MEDIDAS DE RESULTADO:Tasa de fuga anastomótica a los 30 días.RESULTADOS:Se incluyeron un total de 991 pacientes (56% resecciones primarias y 44% resecciones ileocólicas rehechas). Los pacientes de reintervención eran significativamente mayores con más comorbilidades, menos medicamentos y menos enfermedad fistulizante en comparación con el grupo primario. En el análisis univariado, los pacientes reoperados tuvieron más complicaciones generales (50,5% frente a 36,2%, p < 0,001) y el número acumulado de resecciones ileocólicas previas se asoció significativamente con un mayor riesgo de morbilidad general ( p < 0,001). Hubo 31 (3%) fugas anastomóticas; las tasas de fuga no difirieron entre los grupos ( p = 0,6). El análisis multivariado indicó que la adhesiolisis extensa ( p < 0,001), la omisión de ileostomía ( p = 0,009) y el absceso/fístula intraoperatorios ( p = 0,02) se asociaron de forma independiente con fugas, pero no con nueva resección ( p = 0,27). Los pacientes con 0, 1, 2 o 3 de estos factores de riesgo observaron tasas de fuga del 1,1%, 1,3%, 6,0% y 11,6% ( p = 0,03), respectivamente.LIMITACIONES:Sesgo de selección, Sesgo de referencia, un centro de cuarto nivelCONCLUSIÓN:En comparación con los procedimientos primarios, la resección ileocólica para la enfermedad de Crohn recurrente se asocia con una mayor morbilidad general, pero no con una fuga anastomótica. Consulte Video Resumen en http://links.lww.com/DCR/C132 . (Traducción-Dr. Mauricio Santamaria )., (Copyright © The ASCRS 2023.)

Background: Crohn's-related rectovaginal fistulas (RVF) greatly impact quality of life and are notoriously difficult to treat. The aim of this study was to assess the burden of recurrent episodes of care for RVF and its economic impact., Methods: A retrospective observational cohort study of administrative US claims databases was conducted. Eligible patients were female adults, with a diagnosis code for Crohn's disease with or without a diagnosis/procedural code for RVF. For the RVF cohort, rates of recurrence of RVF episodes of care were estimated using Kaplan-Meier analyses. Healthcare resource utilization (HCRU) and direct healthcare costs were compared between the RVF cohort and RVF-free cohort., Results: Mean ages in the RVF cohort (n = 963) and RVF-free cohort (n = 56,564) were 47.2 and 50.8 years, with a mean follow-up period of 58.7 and 49.8 months, respectively. For the RVF cohort, the probability of having a second RVF episode of care within 2 years of the first one was estimated to be 35.9% and of having a third episode within 2 years of the second was 47.8%. During the first 2 years, the RVF cohort had 67% more inpatient admissions than the RVF-free cohort with each RVF episode of care being associated with 16% more admissions. The estimated incremental cost associated with having RVF was US$17,561, with an incremental cost of US$11,607 for each additional RVF episode of care., Conclusions: This real-world study highlights the significant impact of RVF in patients with Crohn's disease with regard to repeat interventions and associated HCRU and direct healthcare costs, suggesting novel therapeutics are needed in this patient population., (© 2023. The Author(s).)

Aim: Diverting loop ileostomy reversal (DLI-R) is routinely performed from 2-6 months following ileal pouch-anal anastomosis (IPAA). The safety of delayed reversal after IPAA is not well-defined. The aim of this study was to determine if prolonged diversion is associated with adverse outcomes compared to routine closure., Methods: Adult patients undergoing primary IPAA with DLI from 2000 to 2021 were included in this retrospective cohort study from our institutional database. Patients were stratified into tertiles based on timing of reversal: Routine (56-116 days), Delayed (117-180 days), or Prolonged (>6 months). Univariate analysis compared categorical variables between groups. Patients reversed at <8 weeks were excluded., Results: In total, 2615 patients underwent DLI-R following IPAA (3-stage 61%, 2-stage 39%; mean age 39.9 years). DLI-R was performed as Routine, Delayed and Prolonged in 1908 (72.9%), 426 (16.4%) and 281 (10.8%), respectively. Overall, DLI-R related complications occurred in 12.4% (n = 324). The complication rate in the Routine group was 11% (n = 210), in the Delayed group was 12.2% (n = 52) and in the Prolonged group was 22.1% (n = 62). Reasons for prolonged diversion in the Prolonged group were complications at the time of IPAA in 207 (73.9%) or patient preference/scheduling in 73 (26.1%). DLI-R >6 months after IPAA due to complications had higher rates of overall complications following ileostomy reversal (OR 2.6, 95% CI 1.85-3.72, p < 0.001) whereas when DLI-R was delayed due to preference/scheduling outcomes were not different than the Routine group (p = 0.28)., Conclusion: Prolonged time to ileostomy reversal after IPAA is probably safe without increased risk of complications when due to patient preference., (© 2023 Association of Coloproctology of Great Britain and Ireland.)

Background: Approximately 30% of Crohn's disease-related perianal fistulas heal in the adult population with conventional medical and surgical interventions. This healing rate remains unknown in pediatric patients., Objective: This study aimed to determine the healing rate of pediatric perianal Crohn's fistulas and identify factors associated with healing., Design: Retrospective case series., Setting: A quaternary referral center., Patients: Patients aged <18 years with a Crohn's perianal fistula, seen between January 1, 1991, and August 1, 2021, were included in the study., Interventions: Multivariable logistic regression to identify factors independently associated with perianal fistula healing., Main Outcome Measures: Healing of Crohn's perianal fistula at the date of last clinical encounter, defined as the clinical note reporting a healed fistula or normal perianal examination., Results: A total of 91 patients aged <18 years with a Crohn's disease-related perianal fistula were identified (59% female, 76% white). The mean (SD) age at Crohn's diagnosis was 12 (±4) years. The mean follow-up after Crohn's diagnosis was 10 (±7) years. Overall, 89% of patients had a perianal fistula, 2% had an anovaginal fistula, and 10% had an ileal pouch-associated fistula. Patients underwent a median (interquartile range) of 2 (1-5) operations. A seton was placed in 60% of patients, 47% underwent abscess drainage, and 44% underwent fistulotomy or fistulectomy. Fistula healing occurred in 71% of patients over a median of 1.3 (0.4-2.5) years. Seven patients (7%) underwent proctectomy, and 3 (3%) underwent ileal pouch excision. After multivariable adjustment, younger age at diagnosis of perianal fistula was associated with an increased likelihood of healing (OR 0.56 for each increased year; 95% CI, 0.34-0.92)., Limitations: Retrospective, single institution., Conclusions: Over two-thirds of fistulas heal in pediatric Crohn's disease patients with conventional surgical and medical intervention. Younger age at fistula development is associated with an increased likelihood of healing. See Video Abstract at http://links.lww.com/DCR/C185 ., Resultados a Largo Plazo De Las Fstulas Perianales En La Enfermedad De Crohn En Pacientes Peditricos: ANTECEDENTES:Aproximadamente el 30% de las fístulas perianales relacionadas con la enfermedad de Crohn se curan en la población adulta con intervenciones médicas y quirúrgicas convencionales. Esta tasa de curación sigue siendo desconocida en pacientes pediátricos.OBJETIVO:Determinar la tasa de curación de las fístulas de Crohn perianales en población pediátrica e identificar los factores asociados con la curación.DISEÑO:Serie de casos retrospectiva.ESCENARIO:Un centro de referencia cuaternario.PACIENTES:Pacientes menores de 18 años con fístula(s) perianal(es) por enfermedad de Crohn, atendidos entre el 1 de enero de 1991 y el 1 de agosto de 2021.INTERVENCIONES:Regresión logística multivariable para identificar factores asociados de forma independiente con la cicatrización de la fístula perianal.PRINCIPALES MEDIDAS DE RESULTADO:Curación de la fístula perianal de Crohn en la fecha del último encuentro clínico, definida como la nota clínica que informa una fístula curada o un examen perianal normal.RESULTADOS:Se identificó un total de 91 pacientes <18 años de edad con una fístula perianal relacionada con la enfermedad de Crohn (59% mujeres, 76% blancos). La edad media (DE) al diagnóstico de Crohn fue de 12 (±4) años. El seguimiento medio tras el diagnóstico de Crohn fue de 10 (±7) años. En general, el 89 % de los pacientes tenía fístula perianal, el 2 % tenía fístula anovaginal y el 10 % de los pacientes tenía fístula asociada a reservorio ileal. Los pacientes fueron sometidos a una mediana (RIC) de 2 (1-5) operaciones. En el 60% de los pacientes se colocó sedal, en el 47% se drenó el absceso y en el 44% se realizó fistulotomía o fistulectomía. La curación de la fístula se produjo en el 71% de los pacientes durante una mediana de 1,3 (0,4-2,5) años. Siete pacientes (7%) se sometieron a proctectomía y 3 (3%) se sometieron a escisión del reservorio ileal. Después del ajuste multivariable, la edad más joven en el momento del diagnóstico de la fístula perianal se asoció con una mayor probabilidad de curación (OR 0,56 por cada año de aumento, IC del 95%, 0,34-0,92).LIMITACIONES:Retrospectivo, institución única.CONCLUSIONES:Más de dos tercios de las fístulas se curan en pacientes pediátricos con enfermedad de Crohn con intervención médica y quirúrgica convencional. Una edad más joven en el momento del desarrollo de la fístula se asocia con una mayor probabilidad de curación. Consulte Video Resumen en http://links.lww.com/DCR/C185 . (Traducción--Dr. Felipe Bellolio )., (Copyright © The ASCRS 2023.)

Background: Postoperative recurrence (POR) of Crohn's disease (CD) is common after surgical resection. We aimed to compare biologic type and timing for preventing POR in adult CD patients after ileocecal resection (ICR)., Methods: We performed a retrospective cohort study of CD patients who underwent an ICR at 2 medical centers. Recurrence was defined by endoscopy (≥ i2b Rutgeerts score) or radiography (active inflammation in neoterminal ileum) and stratified by type and timing of postoperative prophylactic biologic within 12 weeks following an ICR (none, tumor necrosis factor antagonists [anti-TNF], vedolizumab, and ustekinumab)., Results: We identified 1037 patients with CD who underwent an ICR. Of 278 (26%) who received postoperative prophylaxis, 80% were placed on an anti-TNF agent (n = 223) followed by ustekinumab (n = 28, 10%) and vedolizumab (n = 27, 10%). Prophylaxis was initiated in 35% within 4 weeks following an ICR and in 65% within 4 to 12 weeks. After adjusting for factors associated with POR, compared with no biologic prophylaxis, the initiation of an anti-TNF agent within 4 weeks following an ICR was associated with a reduction in POR (adjusted hazard ratio, 0.61; 95% CI, 0.40-0.93). Prophylaxis after 4 weeks following an ICR or with vedolizumab or ustekinumab was not associated with a reduction in POR compared with those who did not receive prophylaxis., Conclusion: Early initiation of an anti-TNF agent within 4 weeks following an ICR was associated with a reduction in POR. Vedolizumab or ustekinumab, at any time following surgery, was not associated with a reduction in POR, although sample size was limited., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Aims: Mesenchymal stem cells [MSCs] have been used for the treatment of perianal Crohn's fistulising disease by direction injection. No studies to date have included patients with an ileal pouch-anal anastomosis [IPAA] in situ., Methods: A phase IB/IIA, randomised, control trial of bone marrow-derived, allogeneic MSCs via direct injection to treat adult patients with a peripouch fistula[s] was conducted; 75 million MSCs were administered with a 22 G needle, with repeat injection at 3 months if complete clinical and radiographic healing was not achieved. Adverse and serious adverse events at post-procedure Day 1, Week 2, Week 6, Month 3, Month 6, and Month 12 were assessed. Clinical healing, radiographic healing per pelvic magnetic resonance imaging [MRI], and patient-reported outcomes were assessed at the same time points., Results: A total of 22 patients were enrolled and treated; 16 were treated and six were controls. There were no adverse or serious adverse events related to MSC therapy. At 6 months, 31% of the treatment group and 20% of the control had complete clinical and radiographic healing. When stratifying the treatment group into perianal [n = 7] and ano-vaginal [n = 8] fistulas, 6-month healing in the treatment groups was 57% and 0%, respectively. The perianal Crohn's disease activity index [PCDAI], Wexner incontinence score, and van Assche score all significantly decreased in treatment patients at 6 months; only the PCDAI decreased in the control group., Conclusion: Bone marrow-derived, allogeneic MSCs offer a safe and effective alternative treatment approach for peripouch fistulas in the setting of a Crohn's like phenotype of the pouch [ClinicalTrials.gov Identifier: NCT04519684.]., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: Rectovaginal fistula occurs in up to 10-20% of women with Crohn's disease, significantly affecting their quality of life. We sought to determine outcomes of single and repeat operative interventions., Methods: A retrospective review of all adult patients with a Crohn's-related rectovaginal fistula, who underwent an operation between 1995 and 2021, was performed. Data collected included patient demographics, Crohn's-related medical treatment, surgical intervention, postoperative outcomes, and fistula outcomes., Results: A total of 166 patients underwent 360 operations; mean age was 42.8 [+/-13.2] years; 34 [20.7%] patients were current and 58 [35.4%] former smokers. The most commonly performed procedure was: a local approach [n = 160, 44.5%] using fibrin glue, fistulotomy/fistulectomy, or seton placement; followed by a transvaginal/transanal approach [n = 113, 31.4%] with an advancement flap repair [including Martius advancement flap] and episoproctotomy; a transabdominal approach [n = 98, 27.2%] including proctectomy or re-do anastomosis; and finally gracilis muscle interposition [n = 8, 2.2%]. The median number of operative interventions per patient was 2 [1.0-3.0] procedures. The overall fistula healing rate per patient was 71.7% [n = 119] at a median follow-up of 5.5 [1.2-9.8] years. Factors that impaired healing included former smoking (odds ratio [OR] 0.52, 95% confidence interval [CI] 0.31-0.87, p = 0.014) and seton insertion [OR 0.42, 95% CI 0.21-0.83, p = 0.012]., Conclusion: Over two-thirds of Crohn's-related rectovaginal fistulas can achieve closure with multiple surgical interventions. Smoking and seton usage negatively affect healing rates and should be avoided., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Inflammatory bowel disease (IBD) patients are at risk for Clostridioides difficile infection (CDI). The majority of published outcomes data feature medically treated patients. We aimed to analyze outcomes in a large cohort of surgical IBD patients diagnosed with CDI., Methods: All patients with IBD in the ACS NSQIP Colectomy and Proctectomy (2015-2019) modules were identified. The IBD-CDI and IBD cohorts were propensity score weighted on demographic and surgical factors and compared., Results: In the entire unmatched cohort (n = 12,782), 119/0.93% patients were diagnosed with CDI (74.2% Crohn's/25.7% UC/Indeterminate colitis) within 30-days of surgery. After propensity score weighting, IBD-CDI was associated with increased risk of readmission (OR 4.55 [3.09-6.71], p < 0.001), reoperation (3.17 [1.81-5.52], p < 0.001) and any complication (2.16 [1.47-3.17], p < 0.001). Any SSI (2.58 [1.67-3.98]), organ space SSI (2.49 [1.51-4.11], both p < 0.001), prolonged ventilation (4.03 [1.39-11.69],p = 0.01), acute renal failure (15.06 [4.26-53.26],p < 0.001), stroke (12.36 [1.26-121.06],p = 0.03), sepsis (2.4 [1.39-4.15],p = 0.002) and septic shock (3.29 [1.36-7.96],p = 0.008) were also higher in the IBD-CDI cohort. Mean length of stay was increased by 39% in CDI patients., Conclusion: Post colonic resection, IBD-CDI patients have worse outcomes than IBD patients without CDI. These patients represent a particularly vulnerable cohort who require close monitoring for the development of postoperative complications., Competing Interests: Declaration of competing interest Tara M. Connelly MBBCh, FRCS, PhD: No disclosures, Stefan D. Holubar MD, MS, FACS, FASCRS: consulting fees, Shionogi, Takeda, Guidepoint; Funding: Crohn's and Colitis Foundation. Cillian Clancy FRCS, MD: No disclosures, Ju Yong Cheong MBBS, PhD: No disclosures, Xue Jia MD, MPH: No disclosures, Anuradha R. Bhama MD, FACS, FASCRS: No disclosures, Amy Lightner, MD, FACS, FASCRS: No disclosures, Hermann Kessler MD, PhD, FACS, FASCRS: No disclosures, Michael Valente DO, FACS, FASCRS: No disclosures, David Liska, MD, FACS, FASCRS: No disclosures. None., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Recommendations regarding venous thromboembolism prophylaxis in patients admitted to the hospital for IBD continue to evolve., Objective: This study aimed to determine the 90-day rate and risk factors of deep venous thromboembolism and pulmonary embolism in cohorts of patients with IBD admitted to medical and surgical services., Design: This was a retrospective review., Setting: The study was conducted at a quaternary IBD referral center., Patients: The study included adult patients ( > 18 y of age) with a known diagnosis of either ulcerative colitis or Crohn's disease who had an inpatient hospital admission for IBD between January 1, 2002, and January 1, 2020., Main Outcome Measures: The primary outcome measures were 90-day rate of deep venous thromboembolism and pulmonary embolism among admitted patients., Results: A total of 86,276 hospital admissions from 16,551 patients with IBD occurred between January 1, 2002, and January 1, 2020. A total of 35,992 patients (41.7%) were given subcutaneous heparin for venous thromboembolism prophylaxis, and 8188 patients (9.49%) were given enoxaparin for venous thromboembolism prophylaxis during the inpatient hospital admission. From the date of hospital admission, the 90-day rate of deep venous thromboembolism was 4.3% (n = 3664); of these, 1731 patients (47%) were diagnosed during the admission and 1933 patients (53%) were diagnosed after discharge. From the date of hospital admission, the 90-day rate of pulmonary embolism was 2.4% (n = 2040); of these, 960 patients (47%) were diagnosed during admission and 1080 patients (53%) were diagnosed after discharge., Limitations: The study was limited by its retrospective nature and unmeasured severity of the disease., Conclusions: Patients admitted for IBD had a 90-day deep venous thromboembolism event rate of 4.3% and pulmonary embolism event rate of 2.4%. More than half of the events occurred after discharge, and venous thromboembolism events were higher among patients with IBD admitted to a medical service than those admitted to a surgical service. See Video Abstract at http://links.lww.com/DCR/B947 ., Tromboembolia Venosa En Pacientes Ingresados Con Enfermedad Inflamatoria Intestinal Una Experiencia En Toda La Empresa De Encuentros Hospitalarios: ANTECEDENTES:Recomendaciones sobre la profilaxis de tromboembolia venosa en pacientes ingresados con enfermedad inflamatoria intestinal (EII) continúa evolucionando.OBJETIVO:Determinar la tasa a 90 días y los factores de riesgo de tromboembolia venosa profunda y embolia pulmonar en cohortes de pacientes ingresados con EII médico y quirúrgico.DISEÑO:Esta fue una revisión retrospectiva.AJUSTE:El estudio se llevó a cabo en un centro cuaternario de derivación de EII.PACIENTES:Se incluyeron pacientes adultos (> 18 años) con diagnóstico conocido de colitis ulcerosa o enfermedad de Crohn que fueron hospitalizados por EII entre el 1 de Enero de 2002 y el 1 de Enero de 2020.PRINCIPALES MEDIDAS DE RESULTADOS:Las medidas principales fueron la tasa de tromboembolia venosa profunda a 90 días y la embolia pulmonar entre los pacientes ingresados.RESULTADOS:Un total de 86.276 ingresos hospitalarios de 16.551 pacientes con EII ocurrieron entre el 1 de Enero de 2002 y el 1 de Enero de 2020. A un total de 35.992 (41,7%) se les administró heparina subcutánea para profilaxis de tromboembolia venosa y a 8.188 (9,49%) se les administró enoxaparina para profilaxis de tromboembolia venosa durante el ingreso hospitalario. A partir de la fecha de ingreso hospitalario, la tasa de tromboembolia venosa profunda a 90 días fue del 4,3% (n = 3.664); de estos 1.731 (47%) se diagnosticaron durante el ingreso y 1.933 (53%) se diagnosticaron después del alta. Desde la fecha de ingreso hospitalario, la tasa de embolia pulmonar a los 90 días fue de 2,4% (n = 2.040); De estos, 960 (47%) fueron diagnosticados durante el ingreso y 1.080 (53%) fueron diagnosticados después del alta.LIMITACIONES:El estudio fue retrospectivo y no se midió la gravedad de la enfermedad.CONCLUSIÓNES:Los pacientes ingresados por EII tuvieron una tasa de tromboembolia venosa profunda y de eventos de embolia pulmonar de 4,3% y 2,4%, respectivamente, a 90 días. Más de la mitad de los eventos ocurrieron después del alta y los eventos de TEV fueron más altos entre los pacientes de EII médicos que quirúrgicos. Consulte Video Resumen en http://links.lww.com/DCR/B947 . (Traducción- Dr. Yesenia Rojas-Khalil )., (Copyright © The ASCRS 2022.)

Background: Patients with IBD with continent ileostomies may require revision surgeries. There remains a paucity of data regarding outcomes after redo continent ileostomy., Objective: This study aimed to evaluate patient outcomes after redo continent ileostomy., Design: Retrospective cohort study., Settings: This study was conducted at a high-volume, specialized colorectal surgery department., Patients: We identified patients who underwent redo continent ileostomy (defined as neo-pouch construction or major operations changing the pouch configuration) for IBD between 1994 and 2020., Main Outcome Measures: The main outcomes measured were patient demographics, short- and long-term outcomes, and quality of life., Results: A total of 168 patients met inclusion criteria; 102 (61%) were female, the mean age was 51 years (±13.1), and the mean BMI was 24.4 (±3.9). The median time between primary and redo continent ileostomy was 16.8 years. One hundred twenty-two patients (73%) who underwent redo surgery had ulcerative colitis, 36 (21%) had Crohn's disease, and 10 (6%) had indeterminate colitis. Slipped nipple valve and valve stricture were the most common indications for redo continent ileostomy (86%). After a median follow-up of 4 years, 48 patients (29%) required a subsequent reoperation and 27 (16%) had pouch failure requiring pouch excision. The pouch survival rate was 89% at 3 years, 84% at 5 years, and 79% at 10 years. On univariate analysis, a shorter interval between the primary and redo continent ileostomy was associated with long-term pouch failure ( p = 0.003). Cox regression multivariate analysis confirmed that a shorter interval between surgeries was independently associated with pouch failure ( p = 0.014). The mean Cleveland Clinic Global Quality of Life score was 0.61 (± 0.23) among the 70 patients who responded to the questionnaire., Limitations: The main limitations were that this was a retrospective, single-center study and that it had a low response rate for the Global Quality of Life questionnaire., Conclusions: Redo continent ileostomy surgery is associated with a long-term pouch retention rate of 79% and satisfactory quality of life. Therefore, redo surgery should be offered to patients who are motivated to keep their continent ileostomy. See Video Abstract at http://links.lww.com/DCR/C87 ., Rehacer La Ileostoma Continente En Pacientes Con Enfermedad Inflamatoria Intestinal Valiosas Lecciones Aprendidas Durante Aos: ANTECEDENTES:Los pacientes con enfermedad inflamatoria intestinal con ileostomías continentes pueden requerir cirugías de revisión. Sigue habiendo escasez de datos con respecto a los resultados después de volver a realizar la ileostomía continente.OBJETIVO:Evaluar los resultados después de rehacer la ileostomía continente.DISEÑO:Estudio de cohorte retrospectivo.ESCENARIO:Departamento especializado en cirugía colorrectal de alto volumen.PACIENTES:Identificamos pacientes que se sometieron a una nueva ileostomía continente (definida como construcción de una nueva bolsa u operaciones mayores que cambian la configuración de la bolsa) por enfermedad inflamatoria intestinal entre 1994 y 2020.PRINCIPALES MEDIDAS DE RESULTADO:Datos demográficos de los pacientes, resultados a corto y largo plazo y calidad de vida.RESULTADOS:Un total de 168 pacientes cumplieron con los criterios de inclusión; 102 (61%) eran mujeres, la edad media fue de 51 años (±13,1) y el IMC medio fue de 24,4 (±3,9). La mediana de tiempo entre la ileostomía primaria y la nueva ileostomía continente fue de 16,8 años. Ciento veintidós pacientes (73%) que se sometieron a una nueva cirugía tenían colitis ulcerosa, 36 (21%) tenían enfermedad de Crohn y 10 (6%) tenían colitis indeterminada. El deslizamiento de la válvula del pezón y la estenosis de la válvula fueron las indicaciones más comunes para rehacer la ileostomía continente (86%). Después de una mediana de seguimiento de 4 años, 48 (29%) pacientes requirieron una reintervención posterior y 27 (16%) tuvieron falla de la bolsa que requirió la escisión de la bolsa. La tasa de supervivencia de la bolsa fue del 89 % a los 3 años, del 84% a los 5 años y del 79% a los 10 años. En el análisis univariable, un intervalo de tiempo más corto entre la ileostomía continente primaria y la nueva se asoció con falla de la bolsa a largo plazo (p = 0,003). El análisis multivariable de regresión de Cox confirmó que el intervalo más corto entre cirugías se asoció de forma independiente con el fracaso de la bolsa (p = 0,014). La puntuación media de la Calidad de Vida Global fue de 0,61 (± 0,23) entre los 70 pacientes que respondieron al cuestionario.LIMITACIONES:Estudio retrospectivo de un solo centro. Baja tasa de respuesta al cuestionario de Calidad de Vida.CONCLUSIÓN:La cirugía de ileostomía continente se asocia con una tasa de retención de la bolsa a largo plazo del 79% y una calidad de vida satisfactoria. Por lo tanto, se debe ofrecer una nueva cirugía a los pacientes que están motivados para mantener su ileostomía continente. Consulte Video Resumen en http://links.lww.com/DCR/C87 . (Traducción-Dr. Felipe Bellolio )., (Copyright © The ASCRS 2022.)

Primary sclerosing cholangitis (PSC) is a progressive liver disease for which there is no effective therapy. Hepatocytes and cholangiocytes from a PSC patient were cocultured with mesenchymal stem cells (MSCs) to assess in vitro change. A single patient with progressive PSC was treated with 150 million MSCs via direct injection into the common bile duct. Coculture of MSCs with cholangiocytes and hepatocytes showed in vitro improvement. Local delivery of MSCs into a single patient with progressive PSC was safe. Radiographic and endoscopic evaluation showed stable distribution of multifocal structuring in the early postoperative period. MSCs may be effective for the treatment of PSC., (© 2022 The Authors. Cell Biology International published by John Wiley & Sons Ltd on behalf of International Federation of Cell Biology.)

Background: Refractory perianal Crohn's disease remains notoriously difficult to treat. We developed a novel technology using a commercially available bioabsorbable fistula plug to deliver autologous adipose-derived mesenchymal stem cells., Objective: This study aimed to assess therapeutic safety and feasibility in the completed STOMP (stem cells on matrix plugs) phase 1 clinical trial., Design: Prospective single-arm phase I clinical trial., Setting: Tertiary academic medical center., Patients: Adults (aged 18-65 y) with complex single-tract Crohn's disease perianal fistula who have failed conventional therapy were included in this study., Intervention: Autologous adipose-derived mesenchymal stem cells were isolated, ex vivo culture expanded, and seeded onto a commercially available bioabsorbable fistula plug. Six weeks later, patients returned to the operating room for removal of the seton and placement of the stem cell-loaded plug., Main Outcome Measures: Patients were followed up for a total of 8 visits through 12 months. Safety was the primary end point; clinical healing and MRI response were secondary end points., Results: Twenty patients (12 females; mean age 36 y) were treated with the stem cell-loaded plug. Of the 20 patients enrolled, 3 were not included in the 12-month analysis because of study withdrawal. Through 12 months, no patient experienced a serious adverse event related to the stem cell-loaded plug. Four patients experienced 7 serious adverse events and 12 patients experienced 22 adverse events. Complete clinical healing occurred in 14 of 18 patients at 6 months and 13 of 17 patients at 12 months. MRI response was observed in 12 of 18 patients at 6 months., Limitations: The main limitations were the small sample size and restrictive inclusion criteria., Conclusions: A stem cell-loaded plug can safely and effectively deliver cell-based therapy for patients with single-tract fistulizing perianal Crohn's disease. See Video Abstract at http://links.lww.com/DCR/C70 ., Respuesta Duradera Observada En Pacientes Con Enfermedad De Crohn Perianal Fistulizante Refractaria Mediante El Uso De Clulas Madre Mesenquimales Autlogas En Una Matriz Disoluble Resultados Del Ensayo De Fase I Stem Cell on Matrix Plug: ANTECEDENTES:La enfermedad de Crohn perianal refractaria sigue siendo notoriamente difícil de tratar. Desarrollamos una tecnología novedosa utilizando un tapón de fístula bioabsorbible disponible comercialmente para administrar células madre mesenquimales derivadas de tejido adiposo autólogo.OBJETIVO:Evaluar la seguridad y viabilidad terapéutica en el ensayo finalizado STOMP.DISEÑO:Ensayo clínico prospectivo de fase I de un solo brazo.AJUSTE:Centro médico académico terciario.PACIENTES:Adultos (18-65) con fístula perianal compleja de la enfermedad de Crohn de un solo tracto que han fracasado con la terapia convencional.INTERVENCIÓN:Se aislaron células madre mesenquimales derivadas de tejido adiposo autólogo, se expandieron en cultivo ex vivo y se sembraron en un tapón de fístula bioabsorbible disponible comercialmente. Seis semanas después, los pacientes regresaron al quirófano para retirar el setón y colocar el tapón cargado de células madre.PRINCIPALES MEDIDAS DE RESULTADO:Los pacientes fueron seguidos durante un total de 8 visitas durante 12 meses. La seguridad fue el criterio principal de valoración; la curación clínica y la respuesta a la resonancia magnética fueron criterios de valoración secundarios.RESULTADOS:Veinte pacientes (12 mujeres, edad media 36 años) fueron tratados con el tapón cargado de células madre. De los 20 pacientes inscritos, tres no se incluyeron en el análisis de 12 meses porque se retiraron del estudio. A lo largo de 12 meses, ningún paciente experimentó un evento adverso grave relacionado con el tapón cargado de células madre. Cuatro pacientes experimentaron 7 eventos adversos graves y 12 pacientes experimentaron 22 eventos adversos. La curación clínica completa ocurrió en 14 de 18 pacientes a los 6 meses y en 13 de 17 pacientes a los 12 meses. La respuesta a la resonancia magnética se observó en 12 de 18 pacientes a los 6 meses.LIMITACIONES:Las principales limitaciones son el tamaño pequeño de la muestra y los criterios de inclusión restrictivos.CONCLUSIONES:Un tapón cargado de células madre se puede administrar de manera segura y efectiva, una terapia basada en células para pacientes con enfermedad de Crohn perianal fistulizante de un solo tracto. Consule Video Resumen en http://links.lww.com/DCR/C70 . (Traducción- Dr. Yesenia Rojas-Khalil )., Competing Interests: Financial Disclosure : Dr Lightner is a consultant for Takeda. Mayo Clinic and Drs Faubion, Dozois, and Dietz have a financial interest related to this research. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic Conflict of Interest policies., (Copyright © The ASCRS 2022.)

Background: The standard of care for surgical treatment of ulcerative colitis is restorative proctocolectomy with ileal J-pouch. Leaks from the tip of the J-pouch are a known complication, but there is a paucity of literature regarding this type of leak., Objective: We aimed to describe the diagnosis, management, and long-term clinical outcomes of leaks from the tip of the J-pouch at our institution., Design: This was a retrospective study of a prospectively maintained pouch registry., Setting: This study was conducted at a quaternary IBD referral center., Patients: Patients included those with ileal J-pouches diagnosed with leaks from the tip of the J-pouch., Main Outcome Measures: The main measures of outcomes were pouch salvage rate, type of salvage procedures, and long-term Kaplan-Meier pouch survival., Results: We identified 74 patients with leaks from the tip of the J-pouch. Pain (68.9%) and pelvic abscess (40.9%) were the most common presentations, whereas 10.8% of patients presented with an acute abdomen. The leak was diagnosed by imaging and/or endoscopy in 74.3% of patients but only discovered during surgical exploration in 25.6% of patients. Some 63.5% of patients were diagnosed only after loop ileostomy closure, whereas 32.4% of patients were diagnosed before ileostomy closure. The most common methods used for diagnosis were pouchoscopy (31.1%) and gastrograffin enema (28.4%). A definitive nonoperative approach was attempted in 48.6% of patients but was successful in only 10.8% of patients overall. Surgical repair was attempted in 89.2% of patients, whereas 4.5% of patients had pouch excision. Salvage operations (n = 63) included sutured or stapled repair of the tip of the J (65%), pouch excision with neo-pouch (25.4%), and pouch disconnection, repair, and reanastomosis (9.5%). Ultimately' 10 patients (13.5%) required pouch excision, yielding an overall 5-year pouch survival rate of 86.3%., Limitations: This was a retrospective review; referral bias may limit the generalizability., Conclusions: Leaks from the tip of the J-pouch have variable clinical presentations and require a high index of suspicion. Pouch salvage surgery is required in the majority of patients and is associated with a high pouch salvage rate. See Video Abstract at http://links.lww.com/DCR/C50 ., Fugas Del Extremo De La Bolsa En J Diagnstico, Manejo Y Supervivencia a Largo Plazo De La Bolsa: ANTECEDENTES:El estándar de atención para el tratamiento quirúrgico de la colitis ulcerosa es la proctocolectomía restauradora con bolsa ileal en J. Las fugas del extremo de la bolsa en J son una complicación conocida, pero hay escasez de literatura sobre este tipo de fuga.OBJETIVO:Describir el diagnóstico, manejo y resultados clínicos a largo plazo de las fugas del extremo de la bolsa en J en nuestra institución.DISEÑO:Estudio retrospectivo de registro de bolsa mantenido prospectivamente.ENTORNO CLINICO:Centro de referencia de enfermedad inflamatoria intestinal cuaternaria.PACIENTES:Pacientes con bolsas ileales en J diagnosticadas con fugas del extremo de la J.PRINCIPALES MEDIDAS DE VALORACIÓN:Tasa de rescate de la bolsa, tipo de procedimientos de rescate y supervivencia a largo plazo de la bolsa Kaplan-Meier.RESULTADOS:Identificamos 74 pacientes con fugas del extremo de la bolsa en J. El dolor (68,9%) y el absceso pélvico (40,9%) fueron las presentaciones más comunes, mientras que el 10,8% de los pacientes presentaron abdomen agudo. La fuga se diagnosticó por imagen y/o endoscopia en el 74,3%, pero solo se descubrió durante la exploración quirúrgica en el 25,6%. El 63,5% fueron diagnosticados solo después del cierre de la ileostomía en asa, mientras que el 32,4% lo fueron antes del cierre de la ileostomía. Los métodos más comunes utilizados para el diagnóstico fueron la endoscopia (31,1%) y el enema de gastrografín (28,4%). Se intentó un abordaje no quirúrgico definitivo en el 48,6%, pero tuvo éxito en solo el 10,8% de los pacientes en general. Se intentó la reparación quirúrgica en el 89,2% de los pacientes, mientras que en el 4,5% se realizó la escisión del reservorio. Las operaciones de rescate (n = 63) incluyeron la reparación con sutura o grapas del extremo de la J (65%), la escisión del reservorio con neo-reservorio (25,4%) y la desconexión, reparación y reanastomosis del reservorio (9,5%). Finalmente, 10 (13,5%) pacientes requirieron la escisión de la bolsa, lo que se asocio con una alta tasa de supervivencia general de la bolsa a los 5 años del 86,3%.LIMITACIONES:Revisión retrospectiva; el sesgo de referencia puede limitar la generalización.CONCLUSIONES:Las fugas del extremo de la bolsa en J tienen presentaciones clínicas variables y requieren un alto índice de sospecha. La cirugía de rescate de la bolsa se requiere en la mayoría y se asocia con una alta tasa de rescate de la bolsa. Consulte Video Resumen en http://links.lww.com/DCR/C50 . (Traducción- Dr. Ingrid Melo )., (Copyright © The ASCRS 2022.)