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.

Fiche publication

Date publication

mai 2024

Journal

Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

Auteurs

Membres identifiés du Cancéropôle Est :
Dr LAKKIS Zaher

Tous les auteurs :
Hain E, Lefèvre JH, Ricardo A, Lee S, Zaghiyan K, McLemore E, Sherwinter D, Rhee R, Wilson M, Martz J, Maykel J, Marks J, Marcet J, Rouanet P, Maggiori L, Komen N, De Hous N, Lakkis Z, Tuech JJ, Sylla P, Attiyeh F, Cotte E

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/38750621

Résumé

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.