Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study.

BACKGROUND

Temporary diverting ostomies have become the predominant approach to reduce anastomotic leakage (AL) after anterior resection. Colovac Device is an anastomosis protection device designed to divert feces from the anastomosis. This study evaluated a new version of the Colovac Device (Colovac 2), used with the novel SmartVac Vacuum Management Device, which is used to anchor the device in the colon.

METHODS

The SAFE-2023 Study was a prospective, multicenter single-arm study that enrolled patients undergoing low anterior resection (LAR) and Colovac placement. The primary performance endpoint was to assess the clinically significant (CS) migration rate of the device through device retrieval. The other performance endpoints were ostomy avoidance rate at Day 10 visit, and fecal diversion success as assessed by cleanliness of the colon immediately prior to device retrieval.

RESULTS

A total of 24 patients were enrolled. 100% (24/24) of the Colovac devices were successfully placed in the intended location, and 100% were successfully removed endoscopically without complications. CS migration occurred in 2 patients (8.3%) on POD8 and POD9, respectively. In both cases, the device was successfully retrieved without complications, good anastomotic healing was confirmed, and no ostomy conversion was performed. The ostomy avoidance rate was 87.5% (21/24) at Day 10 and 83% (20/24) at Day 30 post-device placement. Fecal diversion success assessed immediately prior to device retrieval was 95.8% (23/24).

CONCLUSIONS

The SAFE-2023 study demonstrated a low CS migration rate for the Colovac. The Colovac Device provides a minimally invasive option to protect the anastomosis during the healing process by avoiding the need for a diverting ostomy in 87.5% of patients at Day 10.

TRIAL REGISTRATION: SAFE-2023: NCT06540807.