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

A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: C-REX

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annalisa Spinelli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
• Study Contact Backup: Name: Stefano De Zanet, MS; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • IRCCS Humanitas Research Hospital
      • Contact: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
      • Contact: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it
      • Principal Investigator: Antonino Spinelli, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-REX; Patients will receive the C-REX device during anastomosis construction	Device: 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.; Other Names: C-REX RectoAid Cath device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological anastomotic leaks	Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm	90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 days after surgery
Positive leak tests	Assess the rate of intraoperative positive leak tests in the C-REX arm	Intraoperative
Positive C-REX integrity tests	Assess the rate of intraoperative positive C-REX integrity tests in the C-REX arm	Intraoperative
Time of anastomosis construction	Assess the median time of anastomosis construction in the C-REX arm	Intraoperative
Anastomotic stenosis	Assess the rate of anastomosis stenosis, as assessed by the 90-day endoscopic evaluation in the C-REX arm	90 days after surgery
Postoperative complications	Assess the median Comprehensive Complication Index (CCI) in the C-REX arm	90 days after surgery
Helathcare costs	Evaluate the median healthcare costs (direct and indirect) in the C-REX arm	90 days after surgery
Low Anterior Resection Syndrome	Assess the median Low Anterior Resection Syndrome (LARS) score (ranging from 0 to 40, with 21 indicating significant symtpoms) in the C-REX arm.	90 days after surgery
Investigator's satisfaction	Evaluate the grade of investigator's satisfaction in using the C-REX device by using a simple likert scale ranging from 0 (completely unsatisfaid) to 5 (completely satisfaid).	Intraoperative

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Carponovum AB
• Investigators: Principal Investigator: Antonino Spinelli, MD, PhD, IRCCS Humanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Anastomosis; Colorectal Neoplasm; Surgical device
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 3902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No