OBJECTIVE:To compare the safety and effectiveness of the Colovac Anastomosis Protection Device with standard diverting ostomy (DO) following low anterior resection (LAR) for rectal cancer. SUMMARY BACKGROUND DATA:DO is standard of care (SOC) following LAR for rectal cancer but is associated with substantial morbidity. Colovac Device is designed to divert the fecal stream away from the anastomosis intraluminally. METHODS:Three prospective multicenter Colovac trials were pooled and compared with a prospective cohort of patients undergoing LAR with DO for rectal cancer using a propensity score-weighted approach to balance baseline characteristics. The primary safety endpoint for both Colovac and SOC trials was the rate of device-related or stoma-related early major complications by POD10. Secondary endpoints included early anastomotic leak (AL) rates, fecal stream diversion effectiveness, and device migration. RESULTS:Patients were included (Colovac=49, DO=54). By POD10, device- or stoma-related major complications rates were 4.1% (2/49) vs 5.6% (3/54) (P=0.167). All Colovac devices were successfully placed and retrieved with stoma avoidance achieved in 83.7% at POD10. Major complication rates were similar between groups. Rates of AL detected on POD9/10 were comparable between Colovac and control patients (28.6% vs. 20.4%, P=0.102), with total AL rate of 32.6% in Colovac versus 27.8% (P=0.342) in control at POD30. Effective fecal diversion was achieved in 91.7% of Colovac patients, with device migration in 14.3%. CONCLUSIONS:Colovac enabled ostomy avoidance in most patients without increasing major complications or AL, suggesting its role as a potential alternative to DO following LAR for rectal cancer. TRIAL REGISTRATION:SAFE-2019: NCT05180565; SAFE-2: NCT05010850; SAFE-2023: NCT06540807; SH-SOC23: NCT06152276.

INTRODUCTION:Diverting loop ileostomy (DLI) after low anterior resection for rectal cancer reduces the clinical consequences of anastomotic leakage but is associated with significant morbidity, impaired quality of life and the need for a second operation for stoma closure. Temporary intraluminal bypass devices have been developed to protect the anastomosis while avoiding DLI. However, high-quality prospective data comparing such devices with standard DLI remain limited. This study aims to evaluate the safety and effectiveness of the Colovac device compared with DLI. METHODS AND ANALYSIS:SafeHeal Studies (SAFE-3), consisting of SafeHeal Standard of Care (Diverting Ileostomy) study (SH-SOC23) and SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study (SAFE-3CV), is an international, multicentre, prospective, non-randomised comparative study comprising two sequential cohorts: SH-SOC23 (standard-of-care diverting ileostomy control) and SAFE-3CV (Colovac anastomosis protection device). A total of 233 patients will be enrolled (SAFE-3CV n=108-120; SH-SOC23 n=132) across 25 centres in 4 countries. The primary endpoints are the rate of major complications at 9 months for safety and stoma avoidance at day 10 for effectiveness. Secondary outcomes include overall postoperative morbidity, stoma-related complications, reoperation rates, length of stay and stoma avoidance. Sample size calculation is based on non-inferiority assumptions. Data will be analysed using intention-to-treat principles, with propensity score adjustment to account for baseline differences between cohorts. Comparative analyses will include logistic regression and sensitivity analyses. ETHICS AND DISSEMINATION:The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. An independent safety monitoring committee regularly reviews adverse events and safety data throughout the study. Results will be disseminated through peer-reviewed publications and presentations at international meetings. TRIAL REGISTRATION NUMBERS:SH-SOC23: NCT06152276 and SAFE-3CV: NCT07116668.

Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. NCT05010850.

Anastomotic leaks represent one of the most alarming complications following any gastrointestinal anastomosis due to the substantial effects on post-operative morbidity and mortality of the patient with long-lasting effects on the functional and oncologic outcomes. There is a lack of consensus related to the definition of an anastomotic leak, with a variety of options for prevention and management. A number of patient-related and technical risk factors have been found to be associated with the development of an anastomotic leak and have inspired the development of various preventative measures and technologies. The International Multispecialty Anastomotic Leak Global Improvement Exchange group was convened to establish a consensus on the definition of an anastomotic leak as well as to discuss the various diagnostic, preventative, and management measures currently available.

BACKGROUND: Our primary objective was to demonstrate the utility and feasibility of the intraoperative assessment of colon and rectal perfusion using fluorescence angiography (FA) during left-sided colectomy and anterior resection. Anastomotic leak (AL) after colorectal resection increases morbidity, mortality, and, in cancer cases, recurrence rates. Inadequate perfusion may contribute to AL. The PINPOINT Endoscopic Fluorescence Imaging System allows for intraoperative assessment of anastomotic perfusion.STUDY DESIGN: This is a prospective, multicenter, open-label, clinical trial that assessed the feasibility and utility of FA for intraoperative perfusion assessment during left-sided colectomy and anterior resection at 11 centers in the United States.RESULTS: A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Diverticulitis (44%), rectal cancer (25%), and colon cancer (21%) were the most prevalent indications for surgery. The mean level of anastomosis was 10 +/- 4 cm from the anal verge. Splenic-flexure mobilization was performed in 81% and high ligation of the inferior mesenteric artery in 61.9% of patients. There was a 99% success rate for FA, and FA changed surgical plans in 11 (8%) patients, with the majority of changes occurring at the time of transection of the proximal margin (7%). Overall morbidity rates were 17%. The anastomotic leak rate was 1.4% (n = 2). There were no anastomotic leaks in the 11 patients who had a change in surgical plan based on intraoperative perfusion assessment with FA.CONCLUSIONS: PINPOINT is a safe and feasible tool for intraoperative assessment of tissue perfusion during colorectal resection. There were no anastomotic leaks in patients in whom the anastomosis was revised based on inadequate perfusion with FA. ((C) 2015 by the American College of Surgeons. Published by Elsevier Inc.)

INTRODUCTION: Pyoderma gangrenosum (PG) is a rare, inflammatory skin pathology frequently associated with systemic inflammatory disease. While rare after surgery, recognition of this disease in the post-surgical setting is important as it can mimic wound infection.PRESENTATION OF CASE: We herein present a dramatic presentation of perianal PG four days after routine excision and fulguration of anal condyloma acuminatum. The affected area did not improve with broad spectrum antibiotics or surgical debridement. A diagnosis of PG was made from clinical suspicion and pathology findings, and further confirmed with rapid improvement after starting steroids. Diagnosis of this disease in the postoperative period requires high suspicion when the characteristic ulcerative or bullae lesions are seen diffusely and show minimal improvement with antibiotic treatment or debridement.DISCUSSION: Our case highlights the importance of recognizing this disease in the post-operative period, to allow for early initiation of appropriate treatment and prevent unnecessary surgical debridement of a highly sensitive area. There have been 32 case reports of PG in the colorectal literature, mostly following stoma creation. There is one case report of idiopathic perianal pyoderma gangrenosum with no known prior trauma. To our knowledge there are no previously reported cases of perianal PG after routine elective anorectal surgery.CONCLUSION: This is the first reported case of perianal pyoderma gangrenosum in the post-surgical setting. Increased awareness of pyoderma gangrenosum in the surgical literature will aid in prompt diagnosis and proper medical management of this uncommon postoperative morbidity. (C) 2015 The Authors. Published by Elsevier Ltd. on behalf of IJS Publishing Group Ltd.

Variabilities of both oncologic and functional outcomes are major problems after rectal cancer treatment. Standardized techniques might produce more consistent surgical quality. This study reports outcomes during a 20-year period resulting from a systematically applied surgical approach.

BACKGROUND:There are few studies that compare the incidence of incisional hernia following elective laparoscopic colon resection to open colectomy and determine the risk factors for its development.METHODS:Elective open and laparoscopic colon resections performed between February 2002 and May 2007 were reviewed. In the laparoscopic group, mesenteric transection was performed via intracorporeal division for left-sided colectomy and via extracorporeal technique for right-sided colectomy. The ileocolic anastomosis was performed by extracorporeal stapling for right colectomies and by intracorporeal for left colectomies.RESULTS:Two hundred eighteen patients (mean age 62 years, 52% male) underwent elective colon resection (50% open, 5% hand-assisted, and 45% laparoscopic). Six percent of the cases that started as laparoscopic were converted and are included in the open group. Mean follow-up was 26 months. The overall incisional hernia rate was 16% (open and minimally invasive group 17% vs 15%, P = .14). Hernia was not dependent on the type of resection, indication, or extraction site. Body mass index >36 kg/m(2), male gender, and surgical site infection were risk factors for hernia development.CONCLUSIONS:Laparoscopic colectomy does not reduce the development of incisional hernia.

Radiofrequency ablation (RFA) has changed the treatment strategy of hepatocellular carcinoma. Although RFA is usually applied for the treatment of small (≤3 cm) hepatocellular carcinomas, the combination with hepatic arterial chemoembolization has expanded the use of RFA to larger tumors. Refinements have lessened complications, leading to better prognosis even in the longer term.

Retained foreign body is a recognized complication of abdominal, pelvic, and thoracic surgery and a cause of medical malpractice. Efforts to reduce its incidence include safe exposure and the use of fewer laparotomy pads. The EZ DASH is an absorbent 12-thickness laparotomy pad covering a malleable stainless steel mesh, providing both the needed retraction and a reduction in the use of individual pads. EZ DASH has been introduced into clinical use in 183 consecutive cases by specialty surgeons (colorectal, gynecology, and gynecologic oncology services) at multiple medical centers. The retractor may be shaped to the individual needs of an operating field, eg, the pelvis, and the small bowel secured behind the retractor, held in place by the tension of its mesh and the security of the abdominal wall. Positioning has been intuitive and secure, and the intraoperative use of sponges and of operating time have both been noticeably reduced. Among 183 cases, 91% of uses were felt to reduce OR time by or=10 minutes. Ninety-three percent of EZ DASH cases used fewer individual laparotomy pads for small bowel retraction. Ninety-five percent of uses suggested a value added to the case by the operating surgeon with an expressed desire to use the product repeatedly. The EZ DASH is a simple method of obtaining small bowel retraction and laparotomy pad absorption with a reduction in the need for individual pads, providing excellent exposure for the operative field and reducing the risk of retained foreign body.

BACKGROUND:The rarity of retrorectal cysts and their nonspecific clinical presentations often lead to misdiagnoses and inappropriate operations. In recent years, several such patients have been referred to our institutions for evaluation and treatment of misdiagnosed retrorectal cysts. A review of these patients is presented.STUDY DESIGN:Medical records of the colorectal surgery divisions at two institutions were reviewed. Patients found to have previously misdiagnosed retrorectal cysts were identified. Preliminary diagnoses, radiologic examinations, operative procedures, and final diagnoses were obtained.RESULTS:Seven patients with retrorectal cysts who had been misdiagnosed before referral were identified. These patients had been treated for fistulae in ano, pilonidal cysts, perianal abscesses; psychogenic, lower back, posttraumatic, or postpartum pain, and proctalgia fugax before the correct diagnosis was made. Patients underwent an average of 4.1 operative procedures. Physical examination in combination with CT scanning made the correct diagnosis in all patients. All patients underwent successful resection through a parasacrococcygeal approach, and six of seven did not require coccygectomy. The resected tumors included four hamartomas, two epidermoid cysts, and one enteric duplication cyst.CONCLUSIONS:Retrorectal cysts are a rare entity that can be difficult to diagnose without a high index of clinical suspicion. A history of multiple unsuccessful procedures should alert the clinician to the diagnosis of retrorectal cyst. Once suspected, the correct diagnosis can be made with physical examination and a CT scan before a definitive surgical procedure.

In the design of operations for rectal cancers, the focus is often on circumventing the local extent of disease and leaving the pelvis free of cancer. The local extent of disease may range from minimal intramural invasion to the direct extension of a primary tumor to pelvic sidewall structures, e.g., the internal iliac vessels. In the absence of distant spread, understanding the planes of pelvic anatomy may allow the knowledgeable surgeon to cure patients who would otherwise be declared unresectable. We present the four planes (and one rare situation) available for sharp dissection which allow for the resection of all but a few cases of locally advanced disease.