A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

Not Applicable

Not yet recruiting

• Conditions: Colon Neoplasm
• Interventions: Device: Surgical device

• Registration Number: NCT06615583
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Study Start: 2024-10-01
• Primary Completion: 2025-11-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients aged equal or more than 18 years old, both men and women.
• Patients with a proven diagnosis of sigmoid colon or high rectal tumors requiring anterior rectal resection as procedure of choice (colorectal cancer or benign polyps), as confirmed by radiological and histological exams.
• Patient indicated to minimally invasive or open sigmoid or high rectal resection.

Exclusion Criteria

• Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. Patients with intraoperative evidence of any of these conditions will be withdrawn from the study.
• Patients with preoperative evidence of distal metastasis. Patients with intraoperative evidence of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
• Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. Patients with intraoperative evidence of intestinal or anal stenosis will be withdrawn from the study.
• Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.
• Patients who are unable or received contraindication for the preoperative mechanical preparation. Patients with a preoperative evidence or suspicion of incomplete colon cleansing will be withdrawn from the study.
• Patients indicated to defunctioning stoma. Patients requiring diverting stoma as for intraoperative indication will be withdrawn from the study.
• Patients with an anastomosis in rectum below the peritoneal reflection and/or another procedure of choice than high anterior resection.
• Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-REX arm	Surgical device	Patients will receive the C-REX device during sigmoid or high rectal resection. They will be instructed to follow a low residue diet and administered with a stool softener for five days after the surgical intervention. Approximately ten days after surgery, patients will release the study device and the anastomosis will be assessed with digital endoscopy.

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	90 days after surgery	Rate of radiologically confirmed anastomotic leaks and their severity according to the International Study Group of Rectal Cancer (ISGR) grade

Secondary Outcome Measures

Name	Time	Method
Intraoperative anastomotic failures	Intraoperative	Rate of intraoperative anastomotic construction failures, as confirmed by positive air leak test, reverse air leak test, or C-REX integrity pressure test after anastomosis construction
Time of anastomosis construction	Intraoperative	Median time (in minutes) required to construct the anastomosis using the C-REX device
Time of C-REX evacuation	Ten days after surgery	Median time required to evacuate the anastomotic ring of the C-REX device, in days
Anastomosis stenosis incidence rate	90 days after surgery	Incidence rate of anastomotic stenosis, as confirmed by digital endoscopy

Trial Locations

Locations (1)

IRCCS Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy