Evidence map›Paper›PMID 42285586›Full record

ArticleBMJ open gastroenterology2026

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).

Clément Pastier, Patricia Sylla, Sang W Lee, Antonino Spinelli, Niels Komen, John Marks, Joseph Martz, Rebecca Rhee, Justin Maykel, Jorge Marcet and 13 more

2 registry-linked trialsAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

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.

NCT06152276 completednot on this map

SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)

TypeobservationalSponsorSafeHeal IncRan2024 to 2026Enrolled132ConditionsColorectal Cancer, Stoma IleostomyArmsDiverting loop ileostomy
NCT07116668 naenrolling by invitationnot on this map

SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study: A Study to Evaluate Safety and Effectiveness of the Colovac Anastomosis Protection Device

TypeinterventionalSponsorSafeHeal IncRan2026 to 2027Enrolled108ConditionsColorectal Cancer, Stoma - IleostomyArmsColovac Anastomosis Protection Device placement following low anterior resection of colon cancer
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Clément PastierDepartment of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France.
Patricia SyllaDepartment of Surgery, Icahn School of Medicine at Mount Sinai, New york, New York, USA.
Sang W LeeDivision of Colon and Rectal Surgery, University of Southern California, Los Angeles, California, USA.
Antonino SpinelliDepartment of Biomedical Sciences, Humanitas University, Milan, Italy.
Niels KomenDepartment of Abdominal Surgery, Antwerp University Hospital, Edegem, Belgium.
John MarksLankenau Medical Center, Main Line Health, Wynnewood, Pennsylvania, USA.
Joseph MartzDivision of Colon and Rectal Surgery, Lenox Hill Hospital, New York, New York, USA.
Rebecca RheeDepartment of Surgery, Maimonides Medical Center, Brooklyn, New York, USA.
Justin MaykelDepartment of Surgery, UMass Memorial Medical Center, Worcester, Massachusetts, USA.
Jorge MarcetDivision of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA.
Quentin DenostDepartment of General and Digestive Surgery, Bordeaux Colorectal Institute, Bordeaux, France.
Karen ZaghiyanDepartment of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Jennifer S DavidsDepartment of Surgery, Boston University Chobanian & Avedisian School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
Nivedh PaluvoiDivision of Colon and Rectal Surgery, Department of Surgery, University of Miami, Miller School of Medicine, Coral Gables, Florida, USA.
David HillerNovant Health Colon & Rectal Clinic, Clemmons, North Carolina, USA.
Elisabeth C McLemoreDepartment of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Richmond, California, USA.
Leon MaggioriDepartment of General-Endocrine and Digestive Surgery, Saint Louis Hospital, Paris, France.
Andre D'hooreDepartment of Abdominal Surgery, University Hospitals Leuven, Leuven, Belgium.
Mehraneh D JafariNew York-Presbyterian-Weill Cornell, New York, New York, USA.
Vitaliy PoylinDepartment of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Christopher Jerome BuzasDepartment of General and Colorectal Surgery, Geisinger Medical Center, Danville, Pennsylvania, USA.
Jean-Jaques TuechDepartment of Digestive Surgery, Rouen University Hospital, Rouen, France.
Jérémie H LefèvreDepartment of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France jeremie.lefevre@aphp.fr.ORCID http://orcid.org/0000-0001-7601-7464

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDiverting loop ileostomy (DLI) after low anterior resection for rectal cancer reduces the clinical consequences of anastomotic leakage but is associated with significant morbidity, impaired quality of life and the need for a second operation for stoma closure. Temporary intraluminal bypass devices have been developed to protect the anastomosis while avoiding DLI. However, high-quality prospective data comparing such devices with standard DLI remain limited. This study aims to evaluate the safety and effectiveness of the Colovac device compared with DLI. METHODS AND ANALYSIS: SafeHeal Studies (SAFE-3), consisting of SafeHeal Standard of Care (Diverting Ileostomy) study (SH-SOC23) and SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study (SAFE-3CV), is an international, multicentre, prospective, non-randomised comparative study comprising two sequential cohorts: SH-SOC23 (standard-of-care diverting ileostomy control) and SAFE-3CV (Colovac anastomosis protection device). A total of 233 patients will be enrolled (SAFE-3CV n=108-120; SH-SOC23 n=132) across 25 centres in 4 countries. The primary endpoints are the rate of major complications at 9 months for safety and stoma avoidance at day 10 for effectiveness. Secondary outcomes include overall postoperative morbidity, stoma-related complications, reoperation rates, length of stay and stoma avoidance. Sample size calculation is based on non-inferiority assumptions. Data will be analysed using intention-to-treat principles, with propensity score adjustment to account for baseline differences between cohorts. Comparative analyses will include logistic regression and sensitivity analyses. ETHICS AND DISSEMINATION: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. An independent safety monitoring committee regularly reviews adverse events and safety data throughout the study. Results will be disseminated through peer-reviewed publications and presentations at international meetings. TRIAL REGISTRATION NUMBERS: SH-SOC23: NCT06152276 and SAFE-3CV: NCT07116668.

Indexed as

Anastomosis, SurgicalAnastomotic LeakIleostomyRectal NeoplasmsHumansPostoperative ComplicationsProspective StudiesQuality of LifeReoperationResearch DesignTreatment OutcomeCOLORECTAL CANCERGASTROINTESTINAL FISTULAESURGICAL RESECTION

Identifiers

PMID42285586
PMCPMC13289065

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.