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

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

NCT ID: NCT06481605

Condition: Colorectal Neoplasms

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Colorectal Neoplasm
Anastomosis
Surgical device

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Pilot, single-center, interventional, prospective case-series study.

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: C-REX
Description: 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.
Arm group label: C-REX

Other name: C-REX RectoAid Cath device

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: IRCCS Humanitas Research Hospital

Address:
City: Rozzano
Zip: 20089
Country: Italy

Contact:
Last name: Annalisa Maroli, PhD

Phone: 02 8224 7776

Phone ext: 0039
Email: colorapp@humanitas.it

Contact backup:
Last name: Stefano De Zanet, MS

Phone: 02 8224 4623

Phone ext: 0039
Email: colorapp@humanitas.it

Investigator:
Last name: Antonino Spinelli, MD, PhD
Email: Principal Investigator

Start date: July 31, 2024

Completion date: August 31, 2025

Lead sponsor:
Agency: Istituto Clinico Humanitas
Agency class: Other

Collaborator:
Agency: Carponovum AB
Agency class: Industry

Source: Istituto Clinico Humanitas

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06481605