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Clinical Trials/NCT07241091
NCT07241091RecruitingNot Applicable

A Randomized Controlled Trial of High-Purity Type-I Collagen-Based Biomaterial (Surgicoll-Mesh®) as a Peritoneal Substitute to Prevent Post-Peritonectomy Complications in Patients Undergoing Cytoreductive Surgery

Adichunchanagiri Institute of Medical Sciences, B G Nagara4 sites in 1 country60 target enrollmentStarted: October 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
4
Primary Endpoint
Incidence of major intra-abdominal complications

Study Overview

Brief Summary

This dual-centre, randomized controlled trial evaluates the safety and efficacy of high-purity Type-I collagen-based biomaterial, as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive surgery (CRS) for peritoneal surface malignancy. The study tests whether Surgicoll-Mesh can reduce major postoperative intra-abdominal complications compared with standard management.

Detailed Description

Peritonectomy during CRS often leads to adhesion formation, obstruction, and wound complications. High-purity Type-I collagen-based biomaterial, a resorbable collagen matrix, provides a temporary barrier and scaffold that promotes tissue regeneration and reduces adhesions. This trial will randomize 60 patients (30 per group) to receive standard closure or peritoneal reconstruction with high-purity Type-I collagen-based biomaterial. The primary endpoint is the incidence of major intra-abdominal complications within 2 months. Secondary endpoints include individual complication rates, bowel recovery, hospital stay, mesh-related events, and quality of life

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years
  • Diagnosed peritoneal surface malignancy (colorectal, ovarian, appendiceal, mesothelioma, pseudomyxoma)
  • Undergoing cytoreductive surgery ± HIPEC requiring peritonectomy
  • ECOG 0-2, adequate organ function, informed consent

Exclusion Criteria

  • Collagen allergy or active infection
  • Immunosuppression or chronic steroid use
  • Pregnancy/lactation
  • Uncontrolled sepsis, bowel perforation, or extensive small bowel resection

Outcomes

Primary Outcomes

Incidence of major intra-abdominal complications

Time Frame: 2 months post-surgery

Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery

Secondary Outcomes

  • Quality of life Assessment(2 months)
  • Individual complication rates(2 months)
  • Time to bowel function recovery(1 month)
  • Length of hospital and ICU stay(2 months)
  • Device-related adverse events(2 months)
  • Quality of life Assessment(2 months)
  • Number of participants with MRI-detected intra-abdominal adhesions or obstruction(2 months)

Investigators

Sponsor
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Naveen Narayan MS, MCh (Plastic Surgery)

Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Study Sites (4)

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