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

NCT ID: NCT06481605

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-08-31

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

C-REX

Patients will receive the C-REX device during anastomosis construction

Group Type: EXPERIMENTAL

C-REX

Intervention Type: DEVICE

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.

Interventions

C-REX

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.

Intervention Type: DEVICE

Other Intervention Names

C-REX RectoAid Cath device

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carponovum AB

INDUSTRY

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

Countries

Italy

Central Contacts

Annalisa Spinelli, PhD

Role: CONTACT

colorapp@humanitas.it

02 8224 7776 ext. 0039

Stefano De Zanet, MS

Role: CONTACT

colorapp@humanitas.it

02 8224 7776 ext. 0039

Facility Contacts

Annalisa Maroli, PhD

Role: primary

colorapp@humanitas.it

02 8224 7776 ext. 0039

Stefano De Zanet, MS

Role: backup

colorapp@humanitas.it

02 8224 4623 ext. 0039

Other Identifiers

3902

Identifier Type: -

Identifier Source: org_study_id