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Purpose Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. Trial registration This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554. The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336.

Purpose To assess the value of diffusion-weighted MRI (DW-MRI) in the non-invasive prediction of blastemal remnant after neoadjuvant chemotherapy in nephroblastoma. Methods This IRB-approved study included 32 pediatric patients with 35 tumors who underwent DW-MRI prior and after completion of neoadjuvant chemotherapy and subsequent surgical resection. Two blinded radiologists volumetrically assessed each tumor on pre- and post-neoadjuvant images and the parameters mean ADC, median ADC, 12.5th/25th/75th ADC percentile, skewness, and kurtosis were calculated. Blastemal remnant was determined per the pathology report. Associations between imaging features and blastemal remnant quartiles were examined using the Kruskal–Wallis test and adjusted for false discovery rate. Results Inter-reader agreement was high for mean ADC, skewness, kurtosis, and volume (ICC: 0.76–0.998). Pre-therapeutic histogram parameters skewness and kurtosis were found to be higher in patients with a higher amount of blastemal remnant for reader 1 (overall p = 0.035) and for kurtosis in reader 2 (overall p = 0.032) with skewness not reaching the level of statistical significance (overall p = 0.055). Higher tumor volume on pre-treatment imaging was associated with a higher amount of blastemal remnant after therapy (overall p = 0.032 for both readers). Conclusions Pre-treatment skewness and kurtosis of ADC histogram analysis were significantly associated with a larger fraction of a blastemal remnant after neoadjuvant chemotherapy. These findings could be incorporated into a more personalized chemotherapeutic regime in these patients and offer prognostic information at the time of initial diagnosis.

Background: Space motion sickness (SMS) is the most relevant medical problem during the first days in microgravity. Studies addressing pathophysiology in space face severe technical challenges and microgravity is frequently simulated using the 6° head-down tilt bed rest test (HDT). Aim: We were aiming to test whether SMS could be simulated by HDT, identify related changes in gastrointestinal physiology and test for beneficial effects of exercise interventions. Methods: HDT was performed in ten healthy individuals. Each individual was tested in three study campaigns varying by a 30-min daily exercise intervention of either standing, an upright exercise regimen, or no intervention. Gastrointestinal symptoms, stool characteristics, gastric emptying time, and small intestinal transit were assessed using standardized questionnaires, 13C octanoate breath test, and H2 lactulose breath test, respectively, before and at day 2 and 5 of HDT. Results: Individuals described no or minimal gastrointestinal symptoms during HDT. Gastric emptying remained unchanged relative to baseline data collection (BDC). At day 2 of HDT the H2 peak of the lactulose test appeared earlier (mean±standard error for BDC-1, HDT2, HDT5: 198±7, 139±18, 183±10min; p:0.040), indicating accelerated small intestinal transit. Furthermore, during HDT, stool was softer and stool mass increased (BDC: 47±6, HDT: 91±12, recovery: 53±8g/day; p:0.014), indicating accelerated colonic transit. Exercise interventions had no effect. Conclusion: HDT did not induce symptoms of SMS. During HDT, gastric emptying remained unchanged, but small and large intestinal transit was accelerated.

PURPOSE: Reliable animal models are essential to evaluate future therapeutic options like cell-based therapies for external anal sphincter insufficiency. The goal of our study was to describe the most reliable model for external sphincter muscle insufficiency by comparing three different methods to create sphincter muscle damage. METHODS: In an experimental animal study, female Lewis rats (200-250 g) were randomly assigned to three treatment groups (n = 5, each group). The external sphincter muscle was weakened in the left dorsal quadrant by microsurgical excision, cryosurgery, or electrocoagulation by diathermy. Functional evaluation included in vivo measurements of resting pressure, spontaneous muscle contraction, and contraction in response to electrical stimulation of the afferent nerve at baseline and at 2, 4, and 6 weeks after sphincter injury. Masson's trichrome staining and immunofluorescence for skeletal muscle markers was performed for morphological analysis. RESULTS: Peak contraction after electrical stimulation was significantly decreased after sphincter injury in all groups. Contraction forces recovered partially after cryosurgery and electrocoagulation but not after microsurgical excision. Morphological analysis revealed an incomplete destruction of the external sphincter muscle in the cryosurgery and electrocoagulation groups compared to the microsurgery group. CONCLUSIONS: For the first time, three different models of external sphincter muscle insufficiency were directly compared. The animal model using microsurgical sphincter destruction offers the highest level of consistency regarding tissue damage and sphincter insufficiency, and therefore represents the most reliable model to evaluate future therapeutic options. In addition, this study represents a novel model to specifically test the external sphincter muscle function.

INTRODUCTION: Voluntary muscle activity, including swallowing, decreases during the night. The association between nocturnal awakenings and swallowing activity is under-researched with limited information on the frequency of swallows during awake and asleep periods. AIM: The aim of this study was to assess nocturnal swallowing activity and identify a cut-off predicting awake and asleep periods. METHODS: Patients undergoing impedance-pH monitoring as part of GERD work-up were asked to wear a wrist activity detecting device (Actigraph(®)) at night. Swallowing activity was quantified by analysing impedance changes in the proximal esophagus. Awake and asleep periods were determined using a validated scoring system (Sadeh algorithm). Receiver operating characteristics (ROC) analyses were performed to determine sensitivity, specificity and accuracy of swallowing frequency to identify awake and asleep periods. RESULTS: Data from 76 patients (28 male, 48 female; mean age 56 ± 15 years) were included in the analysis. The ROC analysis found that 0.33 sw/min (i.e. one swallow every 3 min) had the optimal sensitivity (78 %) and specificity (76 %) to differentiate awake from asleep periods. A swallowing frequency of 0.25 sw/min (i.e. one swallow every 4 min) was 93 % sensitive and 57 % specific to identify awake periods. A swallowing frequency of 1 sw/min was 20 % sensitive but 96 % specific in identifying awake periods. Impedance-pH monitoring detects differences in swallowing activity during awake and asleep periods. Swallowing frequency noticed during ambulatory impedance-pH monitoring can predict the state of consciousness during nocturnal periods

Objective: To integrate CT-perfusion into a routine, clinical contrast-enhanced (ce) PET/CT protocol for the evaluation of liver metastases and to compare functional CT and PET parameters. Materials and methods: Forty-six consecutive patients (mean age: 60 (34-82) years; 20 f, 26m) with known liver lesions (colorectal metastases (n=34), primary liver cancer (n=4), breast cancer (n=3), anal cancer, gastric cancer, esophageal cancer, GIST, duodenal cancer (all: n=1) who were referred for staging or therapy follow-up by [18F]-Fluoro-2-deoxy-D-glucose-positron-emission-tomography/computed-tomography imaging (FDG-PET/CT) were included. After acquisition of a low-dose PET/CT, a split-injection (70-90mL) ce-CT-protocol, including a 35-s CT-perfusion scan of the liver and a diagnostic ce-CT of the thorax and/or abdomen (70s delay, iv-contrast volume: 90mL, 4mL/s) was performed. CT-perfusion parameters (BF, BV, MTT,) and semi-quantitative PET-parameters (SUVmax, SUVmean, TLG, PETvol) were analyzed and compared. Results: CT-perfusion data could be obtained in all but one patient with shallow breathing. In all patients, diagnostic ce-PET/CT quality was adequate without the use of additional contrast media. Significant correlations (P

The clinical and morphologic outcome of patients with obstructed defecation syndrome after stapled transanal rectal resection was prospectively evaluated. Twenty-four consecutive patients (22 women; median age, 61 (range, 36–74) years) who suffered from obstructed defecation syndrome and with rectal redundancy on magnetic resonance defecography were enrolled in the study. Constipation was assessed by using the Cleveland Constipation Score. Morphologic changes were determined by using closed-configuration magnetic resonance defecography before and after stapled transanal rectal resection. After a median follow-up of 18 (range, 6–36) months, Cleveland Constipation Score significantly decreased from 11 (range, 1–23) preoperatively to 5 (range, 1–15) postoperatively (P = 0.02). In 15 of 20 patients, preexisting intussusception was no longer visible in the magnetic resonance defecography. Anterior rectoceles were significantly reduced in depth, from 30 mm to 23 mm (P = 0.01), whereas the number of detectable rectoceles did not significantly change. Complications occurred in 6 of the 24 patients; however, only two were severe (1 bleeding and 1 persisting pain requiring reintervention). Clinical improvement of obstructed defecation syndrome after stapled transanal rectal resection correlates well with morphologic correction of the rectal redundancy, whereas correction of intussusception seems to be of particular importance in patients with obstructed defecation syndrome.

The purpose of this study was to assess the accuracy of double-contrast magnetic resonance (MR) imaging for the treatment response evaluation of hepatocellular carcinoma (HCC) in cirrhotic liver after transarterial chemoembolization (TACE). Twenty-two patients with 30 HCC nodules treated by TACE underwent double-contrast MR imaging 1 month after treatment. MR images were obtained before and after the sequential administration of superparamagnetic iron oxide (SPIO) and gadopentetate dimeglumine contrast agent within the same imaging session. Two observers retrospectively assessed all treated nodules for evidence of residual viable tumor after TACE. The diagnostic performance of gadolinium-enhanced, SPIO-enhanced, and double-contrast enhanced images was calculated. Histopathological and angiographical findings served as standard of reference. Receiver operating characteristic curves and areas under the curves (A z) were calculated. Double-contrast technique (A z = 0.95) was significantly (p = 0.036) more accurate than SPIO-enhanced technique (A z = 0.92) and gadolinium-enhanced technique (p = 0.005) (A z = 0.81) in viable tumor detection after TACE. Double-contrast technique was significantly more sensitive (92%) than SPIO-enhanced technique (80%) and gadolinium-enhanced technique (68%). Kappa values for interobserver agreement ranged from 0.67 to 0.87 and were significantly different from zero (all p