Clinical trial NCT06615583: A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection
Official title: A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colon Neoplasm
Keywords: Colorectal neoplasms
Colorectal anastomosis
Anastomotic leak
Surgical device
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Carponovum AB
First posted: 2024-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, single-center, interventional, prospective, single-arm study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Intraoperative anastomotic failures
timeFrame: Intraoperative
measure: Time of anastomosis construction
timeFrame: Intraoperative
measure: Time of C-REX evacuation
timeFrame: Ten days after surgery
measure: Anastomosis stenosis incidence rate
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Antonino Spinelli, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: