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Publications

Journal Article Epublish

PubMed: 42285586 DOI: 10.1136/bmjgast-2025-002235

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 Gastroenterol 13(1)

Authors: Clément Pastier, Patricia Sylla, Sang W Lee, Antonino Spinelli, Niels Komen, John Marks, Joseph Martz, Rebecca Rhee, Justin Maykel, Jorge Marcet, Quentin Denost, Karen Zaghiyan, Jennifer S Davids, Nivedh Paluvoi, David Hiller, Elisabeth C McLemore, Leon Maggiori, Andre D'hoore, Mehraneh D Jafari, Vitaliy Poylin, Christopher Jerome Buzas, Jean-Jaques Tuech, Jérémie H Lefèvre

Affiliations

  • Department of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France.
  • Gut, Liver & Microbiome Research (GLIMMER) FHU, Paris, France.
  • Department of Surgery, Icahn School of Medicine at Mount Sinai, New york, New York, USA.
  • Division of Colon and Rectal Surgery, University of Southern California, Los Angeles, California, USA.
  • Department of Biomedical Sciences, Humanitas University, Milan, Italy.
  • IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
  • Department of Abdominal Surgery, Antwerp University Hospital, Edegem, Belgium.
  • Antwerp RESURG Group, Antwerp Surgical Training, Anatomy and Research Centre (ASTARC), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.
  • Lankenau Medical Center, Main Line Health, Wynnewood, Pennsylvania, USA.
  • Division of Colon and Rectal Surgery, Lenox Hill Hospital, New York, New York, USA.
  • Department of Surgery, Maimonides Medical Center, Brooklyn, New York, USA.
  • Department of Surgery, UMass Memorial Medical Center, Worcester, Massachusetts, USA.
  • Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA.
  • Department of General and Digestive Surgery, Bordeaux Colorectal Institute, Bordeaux, France.
  • Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.
  • Department of Surgery, Boston University Chobanian & Avedisian School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
  • Division of Colon and Rectal Surgery, Department of Surgery, University of Miami, Miller School of Medicine, Coral Gables, Florida, USA.
  • Novant Health Colon & Rectal Clinic, Clemmons, North Carolina, USA.
  • Department of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Richmond, California, USA.
  • Colon and Rectal Surgery Research Chair, LAMC General Surgery Residency, Kaiser Permanente Los Angeles Medical Center (LAMC), Los Angeles, California, USA.
  • Department of General-Endocrine and Digestive Surgery, Saint Louis Hospital, Paris, France.
  • Department of Abdominal Surgery, University Hospitals Leuven, Leuven, Belgium.
  • New York-Presbyterian-Weill Cornell, New York, New York, USA.
  • Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
  • Department of General and Colorectal Surgery, Geisinger Medical Center, Danville, Pennsylvania, USA.
  • Department of Digestive Surgery, Rouen University Hospital, Rouen, France.
  • Department of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France.

Abstract

INTRODUCTION

Diverting 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.

MeSH

Safety, Morbidity, Ileostomy