A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

Launched by ISTITUTO CLINICO HUMANITAS · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the C-REX, which is designed to help prevent leaks and improve healing after surgery for certain types of colon tumors. Specifically, the trial focuses on patients who need surgery to remove tumors from the sigmoid colon or the upper part of the rectum, known as high rectal resection. The main goal is to see how well the C-REX device works in preventing complications within 90 days after surgery.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of a tumor in the sigmoid colon or high rectum that requires surgical removal. However, certain people may not be eligible, including those with serious pre-existing health problems, evidence of cancer spread, or other conditions that could complicate surgery. Participants can expect to be closely monitored after their surgery to assess how well the device is working and to ensure their recovery goes smoothly. This trial is not yet recruiting, so interested individuals should keep an eye out for updates.

Gender

ALL

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 Patients with intraoperative evidence of any of these conditions will be withdrawn from the study.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 Patients with intraoperative evidence of distal metastasis or peritoneal carcinosis will be withdrawn from the study.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 Patients with intraoperative evidence of intestinal or anal stenosis will be withdrawn from the study.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.