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) - Report - MDSpire

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)

  • By

  • 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

  • June 12, 2026

  • 0 min

Share

Clinical Report: Comparative Analysis of the Colovac Anastomosis Protection Device

Background

Anastomotic leakage (AL) is a significant complication following colorectal surgery, particularly low anterior resection, with rates ranging from 5% to 25%. Diverting loop ileostomy (DLI) is the current standard of care to mitigate the consequences of AL, but it is associated with considerable morbidity and the need for subsequent stoma closure. The SAFE-3 study seeks to provide high-quality prospective data comparing the Colovac device to DLI.

Data Highlights

Study CohortsNumber of Patients
SAFE-3CV (Colovac device)108–120
SH-SOC23 (Diverting Ileostomy)132

Key Findings

  • The SAFE-3 study is a multicenter, prospective, non-randomized comparative study.
  • A total of 233 patients will be enrolled across 25 centers in 4 countries.
  • The primary endpoints include major complications at 9 months and stoma avoidance at day 10.
  • Secondary outcomes will assess overall postoperative morbidity and stoma-related complications.
  • Data analysis will utilize intention-to-treat principles with propensity score adjustments.

Clinical Implications

The findings from the SAFE-3 study may provide valuable insights into the effectiveness of the Colovac device as an alternative to DLI, potentially influencing future surgical practices and guidelines. Understanding the comparative safety and effectiveness could lead to improved patient outcomes in colorectal surgery.

Conclusion

The SAFE-3 study aims to fill a critical evidence gap regarding anastomotic protection strategies in colorectal surgery.

Related Resources & Content

  1. Efficacy and Safety of the Colovac 2 Device for Colorectal Anastomosis Protection: Insights from the SafeHeal SAFE-2023 Trial
  2. Comparison analysis of short-term outcomes between degradable stent placement and diverting ileostomy in mid-to-low rectal cancer: a retrospective cohort study
  3. Novel Biomaterial Strategies for Mitigating Anastomotic Leaks in Colorectal Surgical Procedures: A Comprehensive Review
  4. Double-tube End Ileostomy: A Viable Alternative to Conventional Defunctioning Stomas in Rectal Surgical Procedures
  5. SEOM-GEMCAD-TTD clinical guidelines for localized rectal cancer (2025) - PMC
  6. Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study - PubMed
  7. When Is a Diverting Stoma Indicated after Low Anterior Resection? A Meta-analysis of Randomized Trials and Meta-Regression of the Risk Factors of Leakage and Complications in Non-Diverted Patients
  8. SEOM-GEMCAD-TTD clinical guidelines for localized rectal cancer (2025) - PMC
  9. Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study - PubMed
  10. When Is a Diverting Stoma Indicated after Low Anterior Resection? A Meta-analysis of Randomized Trials and Meta-Regression of the Risk Factors of Leakage and Complications in Non-Diverted Patients - ScienceDirect

Original Source(s)

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)

  • by 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

  • June 12, 2026

Related Content

Immunotherapy does not impair ovarian function in a mouse model of breast cancer

ASCO26: Michael Hassett, MD, MPH, eSyM

Dr. Michael Hassett of Dana-Farber Cancer Institute shared new findings showing deployment of eSyM, an ePRO-based, EHR-integrated symptom management program, was associated with statistically significant and potentially meaningful improvements in overall survival. Strategies to improve adoption of ePRO-based symptom management may be warranted.

  • July 1, 2026

  • 1 min
ASCO26: Alicia Morgans, MD, MPH, ARACOG

Dr. Alicia Morgans of Dana-Farber Cancer Institute reported at #ASCO26 that ARACOG found darolutamide was associated with less decline in cognitive testing than enzalutamide, which may help guide treatment choice.

  • July 1, 2026

  • 1 min