A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection

N/ANot Yet RecruitingNCT06481605

Istituto Clinico Humanitas30 enrolled

Overview

The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.

Despite technological advancements, the rate of anastomotic leak after left colon and rectal resection remains high. In most cases, these complications are identified only from the clinical symptoms and the delay in the diagnosis may lead to more severe outcomes. The device C-REX, developed by CarpoNovum, may help the anastomosis construction, providing at the same time a system to monitor the anastomosis until complete 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. The objective of the study is to provide preliminary data to determine whether the C-REX device may reduce the rate and severity of anastomotic leak after left colon and high rectal resection, providing new insights on the feasibility and effectiveness of the C-REX device in a real-word setting.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

C-REXDEVICE

The C-REX is a CE-marked class IIa device consisting of an invasive surgical part, including two anastomotic rings, intended for short-term use, and surgical instruments LapAid and RectoAid for assisting the placement of the anastomotic ring to intestine. The device is supplemented with a catheter to monitor the anastomosis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years old, men or women. * Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice. * Patient indicated to elective minimally invasive 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 preoperative evidence of distal metastasis. * Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. * Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition. * Patients indicated to defunctioning ileostomy (intention to treat). * 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.

Locations (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

Outcomes

Primary Outcomes

Radiological anastomotic leaks

Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm

Time frame: 90 days after surgery

Secondary Outcomes

Severity of anastomotic leaks

Assess the severity of the anastomotic leaks, classifying the events according to the International Study Group of Rectal Cancer (ISGR) criteria in the C-REX arm

Time frame: 90 days after surgery

Positive leak tests

Assess the rate of intraoperative positive leak tests in the C-REX arm

Time frame: Intraoperative

Positive C-REX integrity tests

Assess the rate of intraoperative positive C-REX integrity tests in the C-REX arm

Time frame: Intraoperative

Time of anastomosis construction

Assess the median time of anastomosis construction in the C-REX arm

Time frame: Intraoperative

Anastomotic stenosis

Assess the rate of anastomosis stenosis, as assessed by the 90-day endoscopic evaluation in the C-REX arm

Time frame: 90 days after surgery

Postoperative complications

Assess the median Comprehensive Complication Index (CCI) in the C-REX arm

Time frame: 90 days after surgery

Helathcare costs

Evaluate the median healthcare costs (direct and indirect) in the C-REX arm

Central Contacts

Annalisa Spinelli, PhD

CONTACT

02 8224 7776 colorapp@humanitas.it

Stefano De Zanet, MS

CONTACT

02 8224 7776 colorapp@humanitas.it

Data from ClinicalTrials.gov

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