Clinical trial NCT06481605: A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal 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: Colorectal Neoplasms
Keywords: Colorectal Neoplasm
Anastomosis
Surgical device
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Carponovum AB
First posted: 2024-07-01
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 case-series study.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiological anastomotic leaks
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Severity of anastomotic leaks
timeFrame: 90 days after surgery
measure: Positive leak tests
timeFrame: Intraoperative
measure: Positive C-REX integrity tests
timeFrame: Intraoperative
measure: Time of anastomosis construction
timeFrame: Intraoperative
measure: Anastomotic stenosis
timeFrame: 90 days after surgery
measure: Postoperative complications
timeFrame: 90 days after surgery
measure: Helathcare costs
timeFrame: 90 days after surgery
measure: Low Anterior Resection Syndrome
timeFrame: 90 days after surgery
measure: Investigator's satisfaction
timeFrame: Intraoperative
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, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: