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IntroductionDespite optimal patient selection and surgical effort, recurrence is seen in over 70% of patients undergoing cytoreductive surgery (CRS) for peritoneal metastases (PM). Apart from the Peritoneal Cancer Index (PCI), completeness of cytoreduction and tumour grade, there are other factors like disease distribution in the peritoneal cavity, pathological response to systemic chemotherapy (SC), lymph node metastases and morphology of PM which may have prognostic value. One reason for the underutilisation of these factors is that they are known only after surgery. Identifying clinical predictors, specifically radiological predictors, could lead to better utilisation of these factors in clinical decision making and the extent of peritoneal resection performed for different tumours. This study aims to study these factors, their impact on survival and identify clinical and radiological predictors.Methods and analysisThere is no therapeutic intervention in the study. All patients with biopsy-proven PM from colorectal, appendiceal, gastric and ovarian cancer and peritoneal mesothelioma undergoing CRS will be included. The demographic, clinical, radiological, surgical and pathological details will be collected according to a prespecified format that includes details regarding distribution of disease, morphology of PM, regional node involvement and pathological response to SC. In addition to the absolute value of PCI, the structures bearing the largest tumour nodules and a description of the morphology in each region will be recorded. A correlation between the surgical, radiological and pathological findings will be performed and the impact of these potential prognostic factors on progression-free and overall survival determined. The practices pertaining to radiological and pathological reporting at different centres will be studied.Ethics and disseminationThe study protocol has been approved by the Zydus Hospital ethics committee (27 July, 2020) and Lyon-Sud ethics committee (A15-128).Trial registration numberCTRI/2020/09/027709; Pre-results.

Background Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei (PMP) is associated with excessive bleeding and acquired fibrinogen deficiency. Maintaining plasma fibrinogen may support hemostasis. Objectives To compare hemostatic efficacy and safety of human fibrinogen concentrate (HFC) vs cryoprecipitate as fibrinogen sources for bleeding patients with acquired fibrinogen deficiency undergoing PMP CRS. Methods FORMA‐05 was an off‐label single‐center, prospective, randomized, controlled phase 2 study. Patients undergoing PMP surgery with predicted intraoperative blood loss ≥2 L received human fibrinogen concentrate (HFC; 4 g) or cryoprecipitate (two pools of 5 units, containing approximately 4.0‐4.6 g fibrinogen), repeated as needed. The primary endpoint was a composite of intraoperative and postoperative efficacy, graded using objective 4‐point scales and adjudicated by an independent committee. Results One hundred percent of patients receiving HFC (95% confidence interval: 83.9‐100.0, n = 21) or cryoprecipitate (84.6‐100.0, n = 22) achieved hemostatic success. HFC demonstrated noninferior efficacy (P = .0095; post hoc) and arrived in the operating room 46 minutes faster. There were significantly greater mean increases with HFC vs cryoprecipitate in plasma fibrinogen (0.78 vs 0.35 g/L; P

BACKGROUND: The interest and adoption of transanal total mesorectal excision (TaTME) is growing worldwide, but evidence on nationwide implementation and short-term outcomes is scarce. This study aims to evaluate national results for this relatively new technique in the UK. METHODS: A l l TaTME procedures performed in the UK and recorded on the international TaTME registry between January 2013 and January 2018 were analyzed. Surgeons who received training on TaTME in the UK were sent a survey regarding their experience with implementation of TaTME in their unit. Primary endpoint was a composite for "optimal pathology" (free resection margin (R0) and TME specimen with no major defects and no rectal wall perforations). Sec¬ ondary outcomes included 30-day clinical course and survey outcomes. RESULTS: Forty-two hospitals entered 513 cases over a 5-year period; 28 of 42 hospitals (66.7%) performed ten cases or less. The indication for surgery was cancer in 364 (71.0%) cases. Optimal pathology was achieved in 295 (92.8%), with an involved resection margin (R1) rate of 13 of 513 (4.1%). A Clavien-Dindo >III within 30 days was 13.4% (N.=45) and 6.8% (N.=10) in the cancer and benign groups, respectively. Based on the survey (response rate 68 of 86; 79%), 76.1% of the surgeons implemented TaTME in their unit after receiving training, all of whom experienced difficulties with performing TaTME. CONCLUSIONS: This study reports acceptable nationwide short-term outcomes of TaTME. However, adoption oc¬ curred in a rapid and non-standardized manner. A structured TaTME training program is therefore recommended.

Summary Background Radical surgery via total mesorectal excision might not be the optimal first-line treatment for early-stage rectal cancer. An organ-preserving strategy with selective total mesorectal excision could reduce the adverse effects of treatment without substantially compromising oncological outcomes. We investigated the feasibility of recruiting patients to a randomised trial comparing an organ-preserving strategy with total mesorectal excision. Methods TREC was a randomised, open-label feasibility study done at 21 tertiary referral centres in the UK. Eligible participants were aged 18 years or older with rectal adenocarcinoma, staged T2 or lower, with a maximum diameter of 30 mm or less; patients with lymph node involvement or metastases were excluded. Patients were randomly allocated (1:1) by use of a computer-based randomisation service to undergo organ preservation with short-course radiotherapy followed by transanal endoscopic microsurgery after 8–10 weeks, or total mesorectal excision. Where the transanal endoscopic microsurgery specimen showed histopathological features associated with an increased risk of local recurrence, patients were considered for planned early conversion to total mesorectal excision. A non-randomised prospective registry captured patients for whom randomisation was considered inappropriate, because of a strong clinical indication for one treatment group. The primary endpoint was cumulative randomisation at 12, 18, and 24 months. Secondary outcomes evaluated safety, efficacy, and health-related quality of life assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30 and CR29 in the intention-to-treat population. This trial is registered with the ISRCTN Registry, ISRCTN14422743. Findings Between Feb 22, 2012, and Dec 19, 2014, 55 patients were randomly assigned at 15 sites; 27 to organ preservation and 28 to radical surgery. Cumulatively, 18 patients had been randomly assigned at 12 months, 31 at 18 months, and 39 at 24 months. No patients died within 30 days of initial treatment, but one patient randomly assigned to organ preservation died within 6 months following conversion to total mesorectal excision with anastomotic leakage. Eight (30%) of 27 patients randomly assigned to organ preservation were converted to total mesorectal excision. Serious adverse events were reported in four (15%) of 27 patients randomly assigned to organ preservation versus 11 (39%) of 28 randomly assigned to total mesorectal excision (p=0·04, χ2 test). Serious adverse events associated with organ preservation were most commonly due to rectal bleeding or pain following transanal endoscopic microsurgery (reported in three cases). Radical total mesorectal excision was associated with medical and surgical complications including anastomotic leakage (two patients), kidney injury (two patients), cardiac arrest (one patient), and pneumonia (two patients). Histopathological features that would be considered to be associated with increased risk of tumour recurrence if observed after transanal endoscopic microsurgery alone were present in 16 (59%) of 27 patients randomly assigned to organ preservation, versus 24 (86%) of 28 randomly assigned to total mesorectal excision (p=0·03, χ2 test). Eight (30%) of 27 patients assigned to organ preservation achieved a complete response to radiotherapy. Patients who were randomly assigned to organ preservation showed improvements in patient-reported bowel toxicities and quality of life and function scores in multiple items compared to those who were randomly assigned to total mesorectal excision, which were sustained over 36 months’ follow-up. The non-randomised registry comprised 61 patients who underwent organ preservation and seven who underwent radical surgery. Non-randomised patients who underwent organ preservation were older than randomised patients and more likely to have life-limiting comorbidities. Serious adverse events occurred in ten (16%) of 61 non-randomised patients who underwent organ preservation versus one (14%) of seven who underwent total mesorectal excision. 24 (39%) of 61 non-randomised patients who underwent organ preservation had high-risk histopathological features, while 25 (41%) of 61 achieved a complete response. Overall, organ preservation was achieved in 19 (70%) of 27 randomised patients and 56 (92%) of 61 non-randomised patients. Interpretation Short-course radiotherapy followed by transanal endoscopic microsurgery achieves high levels of organ preservation, with relatively low morbidity and indications of improved quality of life. These data support the use of organ preservation for patients considered unsuitable for primary total mesorectal excision due to the short-term risks associated with this surgery, and support further evaluation of short-course radiotherapy to achieve organ preservation in patients considered fit for total mesorectal excision. Larger randomised studies, such as the ongoing STAR-TREC study, are needed to more precisely determine oncological outcomes following different organ preservation treatment schedules. Funding Cancer Research UK.

Contains fulltext : 238902.pdf (Publisher’s version ) (Closed access) AIMS: Tumour deposits (TDs) are an important prognostic marker in colorectal cancer. However, the classification, and inclusion in staging, of TDs has changed significantly in each tumour-node-metastasis (TNM) edition since their initial description in TNM-5, and terminology remains controversial. Expert consensus is needed to guide the future direction of precision staging. METHODS AND RESULTS: A modified Delphi consensus process was used. Statements were formulated and sent to participants as an online survey. Participants were asked to rate their agreement with each statement on a five-point Likert scale and also to suggest additional statements for discussion. These responses were circulated together with anonymised comments, and statements were modified prior to carrying out a second online round. Consensus was set at 70%. Overall, 32 statements reached consensus. There were concerns that TDs were currently incorrectly placed in the TNM system and that their prognostic importance was being underestimated. There were concerns regarding interobserver variation and it was felt that a clearer, more reproducible definition of TDs was needed. CONCLUSIONS: Our main recommendations are that the number of TDs should be recorded even if lymph node metastases (LNMs) are also present and that nodules with evidence of origin [extramural venous invasion (EMVI), perineural invasion (PNI), lymphatic invasion (LI)] should still be categorised as TDs and not excluded, as TNM-8 specifies. Whether TDs should continue to be included in the N category at all is controversial, and did not achieve consensus; however, participants agreed that TDs are prognostically worse than LNMs and the N1c category is suboptimal, as it does not reflect this.

Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520. Registered on 5 February 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2085-2) contains supplementary material, which is available to authorized users.

International audience; Background and Objectives: The aims of this multi‐institutional study were to assess the feasibility of iterative cytoreductive surgery (iCRS)/hyperthermic intraperitoneal chemotherapy, iCRS in colorectal peritoneal carcinomatosis (CRPC), evaluate survival, recurrence, morbidity and mortality outcomes, and identify prognostic factors for overall survival.Methods: Patients with CRPC that underwent an iCRS, with or without intraperitoneal chemotherapy, from June 1993 to July 2016 at 13 institutions were retrospectively analyzed from prospectively maintained databases.Results: The study comprised of 231 patients, including 126 females (54.5%) with a mean age at iCRS of 51.3 years. The iterative high‐grade (3/4) morbidity and mortality rates were 23.4% and 1.7%, respectively. The median recurrence‐free survival was 15.0 and 10.1 months after initial and iCRS, respectively. The median and 5‐year survivals were 49.1 months and 43% and 26.4 months and 26% from the initial and iCRS, respectively. Independent negative predictors of survival from the initial CRS included peritoneal carcinomatosis index (PCI) > 20 ( P = 0.02) and lymph node positivity ( P = 0.04), and from iCRS, PCI > 10 ( P = 0.03 for PCI 11‐20; P 20), high‐grade complications ( P = 0.012), and incomplete cytoreduction ( P

Publication of surgical activity and mortality was first introduced in the United Kingdom (UK) in 2004 for adult cardiac surgery. The Kennedy Inquiry into paediatric cardiac deaths at the Bristol Royal Infirmary [1] motivated this initiative. The Freedom of Information Act in 2005 and the Francis Report [2] which appeared in 2012 led to the NHS Commissioning Board’s document “Everybody Counts” [3]. Aimed to improve surgical care and promote patient safety, these reports underlined the need for greater transparency and informed patient decision-making. They recommended the publication of surgical “activity, clinical quality measures and survival rates from national audits for every practicing consultant” in nine surgical specialties and in interventional cardiology. Adjusted 90-day mortality rates are currently available online for all colorectal cancer surgeons in England [4], but the introduction of surgeon-specific outcome data (SSD) has raised concerns, not least because of the variable quality of such dataand the statistical methods employed to analyse them [5], but also over the value of these results for informing patient and clinician choice. While good evidence exists that surgeons support the publication of outcome data [6], there is a potential for this to influence a surgeon’s practice adversely, for example in avoiding elective surgery for high-risk patients. Alternative reporting methods may provide a more sensitive quality assessment of treatment by reflecting the multidisciplinary approach to perioperative care rather than that provided by the individual surgeon.

OBJECTIVE: This study aimed to validate a magnetic resonance imaging (MRI) staging classification that preoperatively assessed the relationship between tumor and the low rectal cancer surgical resection plane (mrLRP).BACKGROUND: Low rectal cancer oncological outcomes remain a global challenge, evidenced by high pathological circumferential resection margin (pCRM) rates and unacceptable variations in permanent colostomies.METHODS: Between 2008 and 2012, a prospective, observational, multicenter study (MERCURY II) recruited 279 patients with adenocarcinoma 6 cm or less from the anal verge. MRI assessed the following: mrLRP "safe or unsafe," venous invasion (mrEMVI), depth of spread, node status, tumor height, and tumor quadrant. MRI-based treatment recommendations were compared against final management and pCRM outcomes.RESULTS: Overall pCRM involvement was 9.0% [95% confidence interval (CI), 5.9-12.3], significantly lower than previously reported rates of 30%. Patients with no adverse MRI features and a "safe" mrLRP underwent sphincter-preserving surgery without preoperative radiotherapy, resulting in a 1.6% pCRM rate. The pCRM rate increased 5-fold for an "unsafe" compared with "safe" preoperative mrLRP [odds ratio (OR) = 5.5; 95% CI, 2.3-13.3)]. Posttreatment MRI reassessment indicated a "safe" ymrLRP in 33 of 113 (29.2%), none of whom had ypCRM involvement. In contrast, persistent "unsafe" ymrLRP posttherapy resulted in 17.5% ypCRM involvement. Further independent MRI assessed risk factors were EMVI (OR = 3.8; 95% CI, 1.5-9.6), tumors less than 4.0 cm from the anal verge (OR = 3.4; 95% CI, 1.3-8.8), and anterior tumors (OR = 2.8; 95% CI, 1.1-6.8).CONCLUSIONS: The study validated MRI low rectal plane assessment, reducing pCRM involvement and avoiding overtreatment through selective preoperative therapy and rationalized use of permanent colostomy. It also highlights the importance of posttreatment restaging.

Background Pseudomyxoma peritonei (PMP) is characterized by mucinous ascites, predominantly arising form a perforated tumour of the appendix. This study aimed to assess Health-Related Quality of Life (HRQL) in patients following cytoreductive surgery and intraperitoneal chemotherapy for PMP. Methods Over a one year period, 49 consecutive patients (13 male, 36 females) with a median age of 55 (range 37–81 years) were enrolled. Patients were asked to complete the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire prior to surgery and at one, three, six and twelve months post-operatively. Results 26 patients (53%) underwent complete cytoreduction and 20 (42%) patients had major tumour debulking. One patient died from progressive disease three months from surgery and two patients withdrew from the study within 6 months of surgery. Baseline questionnaire compliance was 100 per cent and remained high (overall 98% of eligible patients) during follow up. Grade III/IV morbidity occurred in 4 patients (9%). Patients undergoing both complete cytoreduction and major tumour debulking reported a clinically significant improvement in emotional well-being, appetite and global HRQL at 1 year following surgery. Conclusion Despite the high morbidity associated with cytoreductive surgery and intraperitoneal chemotherapy, an improvement in quality of life at 1 year following the procedure was seen following both complete cytoreduction and major tumour debulking. Longer term assessment is required to demonstrate the durability of this enhancement.

Background. Anastomotic leakage represents a major complication after anterior resection of the rectum. The incidence of anastomotic leakage varies considerably among clinical studies in part owing to the lack of a standardized definition of this complication. The aim of the present article was to propose a definition and severity grading of anastomotic leakage after anterior rectal resection. Methods. After a literature review a consensus definition, and severity grading of anastomotic leakage was developed within the International Study Group of Rectal Cancer Results. Anastomotic leakage should, be defined as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments. Severity of anastomotic leakage should be graded according to the impact on clinical management. Grade A anastomotic leakage results in no change in patients' management, whereas grade B leakage requires active therapeutic intervention but is manageable without re-laparotomy. Grade C anastomotic leakage requires re-laparotomy. Conclusion. The proposed definition and clinical grading is applicable easily in the setting of clinical studies. It should be applied in future reports to facilitate valid comparison, of the results of different studies. (Surgery 2010;147:339-51.)

Summary Background Adhesions after abdominal and pelvic surgery are important complications, although their basic epidemiology is unclear. We investigated the frequency of such complications in the general population to provide a basis for the targeting and assessment of new adhesion-prevention measures. Methods We used validated data from the Scottish National Health Service medical record linkage database to identify patients undergoing open abdominal or pelvic surgery in 1986, who had no record of such surgery in the preceding 5 years. Patients were followed up for 10 years and subsequent readmissions were reviewed and outcomes classified by the degree of adhesion. We also assessed the rate of adhesion-related admissions in 1994 for the population of 5 million people. Findings 1209 (5·7%) of all readmissions (21 347) were classified as being directly related to adhesions, with 1169 (3·8%) managed operatively. Overall, 34·6% of the 29 790 patients who underwent open abdominal or pelvic surgery in 1986 were readmitted a mean of 2·1 times over 10 years for a disorder directly or possibly related to adhesions, or for abdominal or pelvic surgery that could be potentially complicated by adhesions. 22·1% of all outcome readmissions occurred in the first year after initial surgery, but readmissions continued steadily thoughout the 10-year period. In 1994, 4199 admissions were directly related to adhesions. Interpretation Postoperative adhesions have important consequences to patients, surgeons, and the health system. Surgical procedures with a high risk of adhesion-related complications need to be identified and adhesion prevention carefully assessed.