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

Istituto Clinico Humanitas

Status

Not yet enrolling

Conditions

Colorectal Neoplasms

Treatments

Device: C-REX

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06481605

3902

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.