Comparative Analysis of the Colovac Anastomosis Protection Device Versus Diverting Ileostomy Following Low Anterior Resection: A Protocol for an International, Multicenter, Prospective, Non-Randomized 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

Bmj Open Gastroenterology

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.

Comparative Analysis of the Colovac Anastomosis Protection Device Versus Diverting Ileostomy Following Low Anterior Resection: A Protocol for an International, Multicenter, Prospective, Non-Randomized Study (SAFE-3)

Objective:

Approach:

Key Findings:

Interpretation:

Limitations:

Conclusion:

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)

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