NCT06615583

A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot clinical trial is provide preminary evidence of the effectiveness of the C-REX device, developed by CarpoNovum AB, in preventing anastomotic leak and improving anastomosis healing after sigmoid or high rectal resection in patients with colon neoplasia. The primary aim of the study is to evaluate the rate of anastomotic leak in patients receiving the study device within 90 days from the surgical procedure.

Detailed description

Despite technological advancements, the rate of anastomotic leak after left colon and high rectal resection remains high, around 20%. The device C-REX, developed by CarpoNovum, may help the anastomosis construction and promote its healing. This may lead to reduced anastomotic leak rate and severity. This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial. This pilot study will collect preliminary data on the rate and severity of 90-day anastomotic leak in patients receiving the C-REX device.

Conditions

• Colon Neoplasm

Interventions

Type	Name	Description
DEVICE	Surgical device	The C-REX device consists of an invasive surgical part, including two anastomotic rings, and surgical instruments for assisting the placement of the anastomotic ring to intestine. The rings are loosen from the inside of the intestinal wall and expelled with faeces per rectum once the anastomosis is healed in approximately ten days.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-11-30
• Completion: 2026-03-31
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: Italy