A. N. Morks

Can intraluminal devices prevent or reduce colorectal anastomotic leakage : A review

Colorectal anastomotic leakage is a serious complication of colorectal surgery, leading to high morbidity and mortality rates. In recent decades, many strategies aimed at lowering the incidence of anastomotic leakage have been examined. The focus of this review will be on mechanical aids protecting the colonic anastomosis against leakage. A literature search was performed using MEDLINE, EMBASE, and The Cochrane Collaborative library for all papers related to prevention of anastomotic leakage by placement of a device in the colon. Devices were categorised as decompression devices, intracolonic devices, and biodegradable devices. A decompression device functions by keeping the anal sphincter open, thereby lowering the intraluminal pressure and lowering the pressure on the anastomosis. Intracolonic devices do not prevent the formation of dehiscence. However, they prevent the faecal load from contacting the anastomotic site, thereby preventing leakage of faeces into the peritoneal cavity. Many attempts have been made to find a device that decreases the incidence of AL; however, to date, none of the devices have been widely accepted.

Late anastomotic leakage in colorectal surgery: a significant problem.

Reported incidence rates of colorectal anastomotic leakage (AL) vary between 2.5 and 20%. There is little information on late anastomotic leakage (LAL). The aim of this study was to determine the incidence of LAL after colorectal resection.

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

BackgroundAnastomotic 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.MethodsThe 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.DiscussionThis Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage.Trial registrationNTR3080

The C-seal: A Biofragmentable Drain Protecting the Stapled Colorectal Anastomosis from Leakage

Colorectal anastomotic leakage (AL) is a serious complication in colorectal surgery leading to high morbidity and mortality rates1. The incidence of AL varies between 2.5 and 20% 2-5. Over the years, many strategies aimed at lowering the incidence of anastomotic leakage have been examined6, 7. The cause of AL is probably multifactorial. Etiological factors include insufficient arterial blood supply, tension on the anastomosis, hematoma and/or infection at the anastomotic site, and co-morbid factors of the patient as diabetes and atherosclerosis8. Furthermore, some anastomoses may be insufficient from the start due to technical failure. Currently a new device is developed in our institute aimed at protecting the colorectal anastomosis and lowering the incidence of AL. This so called C-seal is a biofragmentable drain, which is stapled to the anastomosis with the circular stapler. It covers the luminal side of the colorectal anastomosis thereby preventing leakage. The C-seal is a thin-walled tube-like drain, with an approximate diameter of 4 cm and an approximate length of 25 cm (figure 1). It is a tubular device composed of biodegradable polyurethane. Two flaps with adhesive tape are found at one end of the tube. These flaps are used to attach the C-seal to the anvil of the circular stapler, so that after the anastomosis is made the C-seal can be pulled through the anus. The C-seal remains in situ for at least 10 days. Thereafter it will lose strength and will degrade to be secreted from the body together with the gastrointestinal natural contents. The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage. Currently, a phase II study testing the C-seal in 35 patients undergoing (colo-)rectal resection with stapled anastomosis is recruiting. The C-seal can be used in both open procedures as well as laparoscopic procedures. The C-seal is only applied in stapled anastomoses within 15cm from the anal verge. In the video, application of the C-seal is shown in an open extended sigmoid resection in a patient suffering from diverticular disease with a stenotic colon.

Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis

Anastomotic leakage is a potential major complication after colorectal surgery. The C‐seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C‐seal trial was initiated to evaluate the efficacy of the C‐seal in reducing anastomotic leakage in stapled colorectal anastomoses.

Commentary: Letter to the Editor for “Thirty-seven patients treated with the C-seal: protection of stapled colorectal anastomoses with a biodegradable sheath” of Warwick A. et al.

Dear Editor: We thank Miss Warwick and colleagues for their interest in our paper and we appreciate the opportunity to respond to their letter. The heart of the matter is our conclusion from the study that the observed rate of anastomotic leakage is lower than expected from the literature. Several definitions of anastomotic leakage are used in the literature, we chose to use anastomotic leakage leading to reintervention as this is a ‘hard’ end point leaving little room for discussion. This is in accordance with the definition used by the Dutch Surgical Colorectal Audit and other groups. It is true of course that there are patients with an anastomotic leakage who will not undergo treatment for this leak. This may be a radiologic leakage with no clinical consequence or a perianastomotic abscess that becomes asymptomatic after spontaneous drainage. We observed these cases in our study as mentioned by Miss Warwick. We hypothesized that some of these ‘minor’ leaks could have been ‘major’without the use of C-seal. Our inclusion criteria are clearly stated in the paragraph ‘Study Population’ in the Methods section of the paper: age ≥18 years and ASA score ≤3 undergoing colorectal resection with creation of a stapled anastomosis at maximally 15 cm from the anal verge. The C-seal trial will give us the answers we both are waiting for.