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) - Summary - 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

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Objective:

To evaluate the safety and effectiveness of the Colovac device compared with diverting loop ileostomy (DLI) following low anterior resection for rectal cancer.

Approach:
  • Study Design: International, multicenter, prospective, non-randomized comparative study with two cohorts: SH-SOC23 (DLI control) and SAFE-3CV (Colovac device).
  • Participants: 233 patients will be enrolled across 25 centers in 4 countries.
  • Endpoints: Primary endpoints include major complications at 9 months for safety and stoma avoidance at day 10 for effectiveness.
  • Data Analysis: Data will be analyzed using intention-to-treat principles and logistic regression.
Key Findings:
  • Anastomotic leakage occurs in 5–15% of patients after low anterior resection.
  • DLI reduces septic complications but is associated with significant morbidity and the need for stoma closure.
  • Colovac device may provide an alternative to DLI with potentially lower morbidity.
Interpretation:

The study aims to provide high-quality prospective data comparing the Colovac device and DLI, which is currently limited.

Limitations:
  • Non-randomized design may introduce bias.
  • Results may not be generalizable beyond the study population.
Conclusion:

The findings may inform future randomized trials and contribute to evidence-based recommendations on anastomotic protection.

Sources:

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

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