A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

NCT ID: NCT06615583

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-03-31

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.

Conditions

Colon Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-REX arm

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.

Group Type: EXPERIMENTAL

Surgical device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carponovum AB

INDUSTRY

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonino Spinelli, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

Countries

Italy

Central Contacts

Annalisa Maroli, Ph.D.

Role: CONTACT

colorapp@humanitas.it

02 8224 7776 ext. 0039

Stefano De Zanet

Role: CONTACT

colorapp@humanitas.it

02 8224 4623 ext. 0039

Other Identifiers

CHR1-2024-102

Identifier Type: -

Identifier Source: org_study_id