To explore the decision-making factors for defunctioning ileostomy (DI) after rectal cancer surgery and to analyze the impact of the DI on perioperative outcomes.

A retrospective case-control study was conducted that included rectal cancer patients who underwent low anterior resection from January 2013 to December 2023. Among them, 33 patients did not undergo DI but with anastomotic leakage (AL) after surgery, and 1030 patients were without AL. Preoperative, operative and tumor factors between these two groups were compared to explore the decision-making factors for DI. Meanwhile, the differences of perioperative outcomes between the DI group of 381 cases and non-DI group of 701 cases were compared.

For preoperative factors, the proportions of male patients and preoperative chemoradiotherapy (CRT) in the AL with non-DI group were greater than those in the non-AL group (p < 0.05); for operative factors, the proportion of patients in the AL with non-DI group with a surgical time > 180 min were greater (p < 0.05); for tumor factors, the proportion of T3-4 stage was higher in the AL with non-DI group (p < 0.05). Multiple regression analysis revealed that male sex and preoperative CRT were the independent risk factors affecting DI. For perioperative outcomes, the DI did not reduce the incidence of all and symptomatic AL and non-AL postoperative complications (p > 0.05) but with 12.07% stoma-related complications, and increase hospitalization costs (p < 0.05); however, it can shorten the postoperative hospital stay, pelvic drainage tube removal time, and reduce the anal tube placement rate and readmission rate (all p < 0.05).

Male patients and preoperative CRT were the independent risk factors affect the decision of DI in our study, and DI can shorten the postoperative hospitalization, pelvic drainage tube removal time, and decrease the anal tube placement rate and readmission rate during the perioperative period but with a higher economic cost.

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.

This study aimed to investigate the safety and feasibility of a novel stent-assisted ileal bypass for rectal cancer patients who received sphincter-preserving surgery.

Patients who were diagnosed with rectal cancer and received sphincter-preserving surgery plus a novel stent-assisted ileal bypass were respectively included from January 2022 to January 2023. Biofragmentable ileal stent with diaphragm sheet in the cavity was placed in the terminal ileum using absorbable sutures after anastomosis. At the proximal end of the stent, an intestinal diversion tube was placed in the prefabricated purse-string, through which faeces were drained. The stent completely disintegrated in the body after 3-4 weeks, which protected the anastomosis after surgery and avoided protective stoma. Clinical characteristics and surgical outcomes were collected.

Eleven patients who successfully received surgery were included. There were seven (63.6%) males and four (36.4%) females. The tumour size was 3.2 ± 1.7 cm and the lower verge of tumour to anal verge was 6.8 ± 1.3 cm. As for surgical outcomes, operation time was 216.4 ± 54.1 min, blood loss was 43.6 ± 64.6 mL, time to first flatus via intestinal diversion tube was 3.2 ± 1.1 days, time to discharge stent was 22.8 ± 3.0 days, and postoperative hospital stay was 21.0 ± 5.4 days. Two patients suffered from postoperative complications including pneumonia and incision infection.

This novel stent-assisted ileal bypass is safe and feasible, it provides a new choice for rectal cancer patients to avoid protective stoma and secondary surgery.

Diverting ileostomy and colostomy after total mesorectal excision reduces the risk of complications related to anastomotic leakages but is associated with a reduction in health-related quality of life and long-term economic consequences that are unknown. Our objective was to estimate the lifetime costs of stoma placement after rectal cancer resection in the U.S., England, and Germany.

Input parameters were derived from quasi-systematic literature searches. Decision-analytic models with survival from colorectal cancer-adjusted life tables and country-specific stoma reversal proportions were created for the three countries to calculate lifetime costs. Main cost items were stoma maintenance costs and reimbursement for reversal procedures. Discounting was applied according to respective national guidelines. Sensitivity analysis was conducted to explore the impact of parameter uncertainty onto the results.

The cohort starting ages and median survival were 63 and 11.5 years for the U.S., 69 years and 8.5 years for England, and 71 and 6.5 years for Germany. Lifetime discounted stoma-related costs were $26,311, £9512, and €10,021, respectively. All three models were most sensitive to the proportion of ostomy reversal, age at baseline, and discount rate applied.

Conservative model-based projections suggest that stoma care leads to significant long-term costs. Efforts to reduce the number of patients who need to undergo a diverting ostomy could result in meaningful cost savings.

Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period. The objective of this clinical trial was to evaluate the preliminary efficacy and safety of the Colovac+.

This was a prospective, multicenter, pilot study aiming to enroll 15 patients undergoing LAR with Colovac+ placement. After 10 days, a CT scan was performed to evaluate the anastomosis and the Colovac+ was retrieved endoscopically. During the 10-day implantation and 3-month follow-up period, we collected data regarding predefined efficacy and safety endpoints. The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure.

A total of 25 patients were included (68% male), of whom 15 were consecutively treated with the Colovac+ and Vacuum Loss Alert System. The Colovac+ was successfully implanted in all 15 patients. No major discomfort was reported during the implantation period. The endoscopic retrieval was performed in 14/15 (93%) patients. The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. A device migration occurred in 2 (13%) patients, but these were not associated with AL or stoma conversion. Overall, Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the PI in 11/15 (73%) patients.

Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the majority (73%) of patients. The improved design reduces the overall migration rate and limits the clinical impact of a migration.

Our previously published clinical studies described the short-term outcomes of a newly developed intraluminal fecal diverting device (FDD). FDD was a safe and effective substitute for a defunctioning stoma. However, the long-term efficacy and safety of this device remain unknown. We investigated the long-term outcomes of the use of the FDD as a substitute for a defunctioning stoma.

We examined the medical records of patients who participated in our two previous FDD clinical studies. The main outcome was the number of patients with bowel continuity for 2 years after undergoing the FDD procedure or defunctioning stoma creation.

Between May 2015 and July 2018, 85 patients were screened for inclusion in this study. Of those, 27 patients underwent a defunctioning ileostomy after proctectomy. The remaining 58 underwent the FDD procedure after proctectomy. Seventy-two patients (ileostomy group, n = 22; FDD group, n = 50) with a follow-up duration > 24 months were included in this analysis. The mean duration of fecal diversion was significantly shorter (p < 0.001) in the FDD group (3.1 [1.6-6.1] weeks) than in the ileostomy group (16.7 [10.0-31.6] weeks). However, the rate of permanent stoma creation was not statistically different between the two groups (ileostomy and FDD groups, 13.6% [3/22] and 10.0% [5/50], respectively; p = 0.693).

The FDD procedure is a feasible substitute for a defunctioning stoma after proctectomy. Multicenter large-scaled clinical studies are required to validate our results.

BackgroundThe protective ostomy is the current standard of care to protect a low colorectal anastomosis from leakage, but exposes patients to complications requiring an alternative strategy. The Colovac+ is a vacuum-based intraluminal bypass device designed to shield the anastomosis from fecal content, preventing the clinical outcomes of anastomotic leakage. The objective of this study was to evaluate the preliminary efficacy, safety, and technical feasibility of the Colovac+ in a porcine model. Methods: Twelve pigs received a colorectal anastomosis with Colovac+ implantation. The device was left in situ for 10 days and then retrieved endoscopically. Six pigs were to be sacrificed immediately after device retrieval and the other 6 were to be sacrificed on day 38. Clinical, endoscopic, and histopathological examinations were performed to evaluate the following endpoints: prevention of contact between the anastomosis and fecal content, device migration, feasibility of the implantation and retrieval procedure, collateral damage to the colonic wall, colon healing after device retrieval, and systemic toxicity related to the device. Results: Eleven pigs completed the study. One pig died prematurely due to a surgical complication unrelated to the device (bladder damage with uroperitoneum). There was no evidence of contact between the anastomosis and fecal content, none of the pigs developed symptomatic anastomotic leakage, there were no significant device migrations, and there was no evidence of systemic toxicity. Colovac+ implantation was easily performed in all cases except 1 (due to an inappropriate lubricant). Colovac+ retrieval was achieved successfully in all cases. Postretrieval examinations on day 10 revealed ulcerations at the anchoring site in 4 cases indicating mechanical damage caused by the stent. However, in the recovery group, no ulcerations were observed on day 38, and the colonic wall had properly healed in all animals. Conclusions: The Colovac+ is a technically feasible, safe, and efficient device for the protection of a colorectal anastomosis in a porcine model. The device holds promise for clinical use and warrants further research.

Anastomotic leakage (AL) is the most important complication of colorectal surgery, leading to high morbidity and mortality. Protective ostomy, the current standard of care for protecting a colorectal anastomosis, has important drawbacks that require the creation of an alternative strategy. Over the past 30 years, several intraluminal bypass devices, designed to shield the anastomosis from the faecal stream, have been developed. The aim of this literature review was to create an updated overview of the devices available and their effectiveness in preventing AL, and to investigate whether they could serve as an alternative to protective ostomy in the future.

A systematic review of the literature on intraluminal bypass devices used for preventing colorectal AL was performed. The MEDLINE and Cochrane Library databases were searched, and articles were marked as relevant if an intraluminal bypass device was studied in an animal or human population.

The database search yielded 24 relevant articles related to 10 intraluminal bypass devices protecting a colorectal anastomosis. These articles included experimental animal studies, preclinical (pilot) studies, as well as retrospective and prospective clinical studies. Each device was assessed with regard to surgical technique, effectiveness and device-related complications.

Intraluminal bypass devices show promise in preventing AL and its clinical consequences. However, there is insufficient high-level evidence to draw firm conclusions. There is a need for randomized controlled trials that directly compare these devices with the protective ostomy.