ArticleSurgical endoscopy2023
Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.
Article in Surgical endoscopy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Novel adjunctive technologies for the prevention of colorectal anastomotic leakage: a systematic review.Techniques in coloproctology · 2026Pooled it
- Anastomotic reinforcement in rectal surgery: a position statement from an expert panel of colorectal surgeons.Updates in surgery · 2026Article
- Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3).BMJ open gastroenterology · 2026Article
- Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study.Surgical endoscopy · 2026Article
- Taming colonic anastomotic leakage: Wisdom from the ancient Chinese legend of Yu the Great.World journal of gastrointestinal surgery · 2025Article
- Advanced innovations in reducing anastomotic leak: a review of emerging biomaterial applications in colorectal surgery.International journal of colorectal disease · 2025Review
- Clinical using of innovative biodegradable stent with extension sleeve in Ta_tme for low rectal cancer with high risk of anastomotic leakage.Scientific reports · 2025Article
- Analysis of decision-making factors for defunctioning ileostomy after rectal cancer surgery and their impact on perioperative recovery: a retrospective study of 1082 patients.Surgical endoscopy · 2024Article
- Endoscopic Vacuum Therapy: When and How to Use It?GE Portuguese journal of gastroenterologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProtective 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+.
methodsThis 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.
resultsA 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.
conclusionsColovac+ 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.
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