[C-seal for prevention of anastomotic leakage following colorectal anastomosis].

The C-seal is a new product for prevention of anastomotic leakage following colorectal anastomosis. Anastomotic leakage is a much-feared complication of colorectal surgery, with an incidence of around 11%. The C-seal is a biodegradable sheath that is attached to the inner surface of the bowel, just above the colorectal anastomosis, with a circular stapler. Intestinal contents drain from the body via the C-seal. The C-seal can be used in stapled anastomoses at up to 15 cm from the anus and is compatible with all circular staplers. To date, 50 patients have been treated with a C-seal. Results are encouraging and therefore the C-seal is soon to be investigated under randomized study conditions

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial.

BACKGROUND: Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence.The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30  days postoperative. METHODS: The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30  days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18  years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis. DISCUSSION: This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage

Documenting correct assessment of biliary anatomy during laparoscopic cholecystectomy

BACKGROUND: Correct assessment of biliary anatomy can be documented by photographs showing the “critical view of safety” (CVS) but also by intraoperative cholangiography (IOC). METHODS: Photographs of the CVS and IOC images for 63 patients were presented to three expert observers in a random and blinded fashion. The observers answered questions pertaining to whether the biliary anatomy had been conclusively documented. RESULTS: The CVS photographs were judged to be “conclusive” in 27%, “probable” in 35%, and “inconclusive” in 38% of the cases. The IOC images performed better and were judged to be “conclusive” in 57%, “probable” in 25%, and “inconclusive” in 18% of the cases (P < 0.001 compared with the photographs). The observers indicated that they would feel comfortable transecting the cystic duct based on the CVS photographs in 52% of the cases and based on the IOC images in 73% of the cases (P = 0.004). The interobserver agreement was moderate for both methods (kappa values, 0.4–0.5). For patients with a history of cholecystitis, both the CVS photographs and the IOC images were less frequently judged to be sufficient for transection of the cystic duct (P = 0.006 and 0.017, respectively). CONCLUSION: In this series, IOC was superior to photographs of the CVS for documentation of the biliary anatomy during laparoscopic cholecystectomy. However, both methods were judged to be conclusive only for a limited proportion of patients, especially in the case of cholecystitis. This study highlights that documenting assessment of the biliary anatomy is not as straightforward as it seems and that protocols are necessary, especially if the images may be used for medicolegal purposes. Documentation of the biliary anatomy should be addressed during training courses for laparoscopic surgery

Thirty-seven patients treated with the C-seal:protection of stapled colorectal anastomoses with a biodegradable sheath

<p>The present study was performed to get a better insight in the incidence of anastomotic leakage leading to reintervention when using the C-seal: a biodegradable sheath that protects the stapled colorectal anastomosis from leakage.</p><p>The C-seal is a thin walled tube-like sheath that forms a protective sheath within the bowel lumen. Thirty-seven patients undergoing surgery with creation of a stapled colorectal anastomosis with C-seal were analyzed. Follow-up was completed until 3 months after surgery.</p><p>One patient (3 %) developed anastomotic leakage leading to reintervention. None of the 37 anastomoses was dismantled. One patient was diagnosed with a rectovaginal fistula. In three patients (8 %), a perianastomotic abscess spontaneously drained.</p><p>The incidence of anastomotic leakage leading to reintervention when using the C-seal (3 %) is lower than expected based on the literature (11 %). We have currently set-up a multicenter randomized trial to confirm the efficiency of the C-seal (www.csealtrial.nl).</p>