Treating acute colonic diverticulitis with extraluminal pericolic air: An Acute Care Surgery in the Netherlands (ACCSENT) multicenter retrospective cohort study.

BACKGROUND: Owing to improved quality of computed tomography, a new category of complicated acute diverticulitis, including patients with pericolic air but without abscess formation, can be defined (Hinchey 1a). Recent studies question whether this new category of acute diverticulitis could be treated as uncomplicated cases. The aim of our study is to report on the clinical course of acute diverticulitis Hinchey 1a in current clinical practice. METHODS: For this multicenter retrospective cohort study, patients presenting at the emergency department with Hinchey 1a acute diverticulitis as demonstrated by computed tomography scan, were identified. The primary outcome measure was successful conservative treatment with observation alone, antibiotics, and/or hospital admission. Readmissions, percutaneous drainage of abscesses, and emergency operations were considered as failure. RESULTS: Between October 2016 and October 2018, 1,199 patients were clinically suspected for acute diverticulitis, of whom 101 (8.4%) were radiologically diagnosed to have type 1a acute diverticulitis (average age 57 (±13) years, 45% female) and started with conservative treatment. This was successful in 86 (85%) patients. One of the 15 unsuccessfully treated patients (1%) received percutaneous drainage of an abdominal abscess. Surgery was required in 9 cases (9%) after a median time of 6 days (range, 3 to 69 days). Although a difference in the volume of extraluminal air on computed tomography scan was found, this was not shown to be a risk factor for the clinical course. CONCLUSION: Patients with type 1a acute diverticulitis can be treated successfully by conservative therapy in the majority of cases (85%). More research is required to define predictive factors for successful conservative management.

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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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).

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.

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.

[C-seal for prevention of anastomotic leakage following colorectal anastomosis]. / C-seal tegen naadlekkage bij colorectale anastomosen.

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: 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 rates. The incidence of AL varies between 2.5 and 20%. Over the years, many strategies aimed at lowering the incidence of anastomotic leakage have been examined. 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 atherosclerosis. 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. 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 15 cm 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.

Current surgical treatment of diverticular disease in The Netherlands.

AIM: To evaluate the development of diagnostic tools, indications for surgery and treatment modalities concerning diverticular disease (DD) in The Netherlands. METHODS: Data were collected from 100 patients who underwent surgery for DD in three Dutch hospitals. All hospitals used the same standardized database. The collected data included patient demographics, patient history, type of surgery and complications. Patients were divided into two groups, one undergoing elective surgery (elective group) and the other undergoing acute surgery (acute group). RESULTS: Two hundred and ninety-nine patients were admitted between 2000 and 2007. One hundred and seventy-eight patients underwent acute surgery and 121 patients received elective operations. The median age of the 121 patients was 69 years (range: 28-94 years), significantly higher in acute patients (P = 0.010). Laparoscopic resection was performed in 31% of elective patients. In the acute setting, 61% underwent a Hartmann procedure. The overall morbidity and mortality were 51% and 10%, and 60% and 16% in the acute group, which were significantly higher than in the elective group (36% and 1%). Only 35% of the temporary ostomies were restored. CONCLUSION: This study gives a picture of current surgical practice for DD in The Netherlands. New developments are implemented in daily practice, resulting in acceptable morbidity and mortality rates.