SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study : an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device

Hain, Elisabeth; Lefevre, Jeremie H.; Ricardo, Alison; Lee, Sang; Zaghiyan, Karen; Mclemore, Elisabeth; Sherwinter, Danny; Rhee, Rebecca; Wilson, Matthew; Martz, Joseph; Maykel, Justin; Marks, John; Marcet, Jorge; Rouanet, Philippe; Maggiori, Leon; Komen, Niels; De Hous, Nicolas; Lakkis, Zaher; Tuech, Jean-Jacques; Sylla, Patricia; Attiyeh, Fadi; Cotte, Eddy

doi:10.1111/CODI.17012

Title

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study : an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device

Author

Hain, Elisabeth

Lefevre, Jeremie H.

Ricardo, Alison

Lee, Sang

Zaghiyan, Karen

Mclemore, Elisabeth

Sherwinter, Danny

Rhee, Rebecca

Wilson, Matthew

Martz, Joseph

Maykel, Justin

Marks, John

Marcet, Jorge

Rouanet, Philippe

Maggiori, Leon

Komen, Niels

De Hous, Nicolas

Lakkis, Zaher

Tuech, Jean-Jacques

Sylla, Patricia

More...

Abstract

Aim: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. Methods: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. Discussion: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. Trial registration: NCT05010850.

Language

English

Source (journal)

Colorectal disease. - Oxford

Publication

Hoboken : Wiley , 2024

ISSN

1462-8910

DOI

10.1111/CODI.17012

Volume/pages

26 :6 (2024) , p. 1271-1284