A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

NCT06615583 | Not Yet Recruiting

• 1 other identifier: CHR1-2024-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Neoplasm

Keywords

Colorectal neoplasms; Colorectal anastomosis; Anastomotic leak; Surgical device

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak rate

  Rate of radiologically confirmed anastomotic leaks and their severity according to the International Study Group of Rectal Cancer (ISGR) grade

  90 days after surgery

Secondary Outcomes (4)

• Intraoperative anastomotic failures

  Intraoperative

• Time of anastomosis construction

  Intraoperative

• Time of C-REX evacuation

  Ten days after surgery

• Anastomosis stenosis incidence rate

  90 days after surgery

Study Arms (1)

C-REX arm

EXPERIMENTAL

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.

Device: Surgical device

Interventions

Surgical device 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.

C-REX arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Carponovum AB: collaborator

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Anastomotic Leak

Interventions

Surgical Fixation Devices

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Antonino Spinelli, M.D., Ph.D.

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, Ph.D.

CONTACT

02 8224 7776; colorapp@humanitas.it

Stefano De Zanet

CONTACT

02 8224 4623; colorapp@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, single-center, interventional, prospective, single-arm study

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: March 31, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)