A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection
ConditionColon Neoplasm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 Patients with intraoperative evidence of any of these conditions will be withdrawn from the study.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 Patients with intraoperative evidence of distal metastasis or peritoneal carcinosis will be withdrawn from the study.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 Patients with intraoperative evidence of intestinal or anal stenosis will be withdrawn from the study.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.
Trial design
Treatments tested in this trial
- Surgical device
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Istituto Clinico Humanitas
Lead sponsor
Carponovum AB
Collaborator
Source ClinicalTrials.gov