SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery

March 27, 2026 updated by: Dr Naveen Narayan MS, MCh (Plastic Surgery), Adichunchanagiri Institute of Medical Sciences, B G Nagara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mandya, Karnataka, India, 571448
        • Adichunchanagiri Institute of Medical Sciences
      • Mysore, Karnataka, India, 570004
        • JSS Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Purity Type-I Collagen-based Peritoneal Substitute
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
Device: High-Purity Type-I Collagen Scaffold
Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
Active Comparator: Standard Peritonectomy Closure
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Procedure: Standard Peritonectomy Closure
Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual Complication Rates
Time Frame: 2 months
Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)
2 months
Time to Bowel Function Recovery
Time Frame: 1 month
Time to bowel function recovery and diet tolerance
1 month
Length of Intensive Care Unit Stay
Time Frame: During index hospitalization
Duration of postoperative intensive care unit stay following cytoreductive surgery.
During index hospitalization
Length of Hospital Stay
Time Frame: During index hospitalization
Total duration of hospitalization following cytoreductive surgery.
During index hospitalization
Device-related Adverse Events
Time Frame: Within 2 months after surgery
Any adverse event deemed related to the implanted High-Purity Type-I Collagen biomaterial, including mesh reaction, infection, seroma, rejection, or need for mesh removal, assessed within the 2-month postoperative period.
Within 2 months after surgery
MRI-Detected Intra-Abdominal Adhesions
Time Frame: Within 2 months after surgery
Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.
Within 2 months after surgery
Change in Quality of Life Domains (EORTC QLQ-C30)
Time Frame: Baseline to 2 months after surgery

Change from baseline in quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale.

For global health and functional scales, higher scores indicate better outcomes and higher change values represent improvement.

For pain (symptom scales), higher scores indicate worse symptoms; therefore, reductions from baseline represent improvement
Baseline to 2 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Collaborators

JSS Medical College Hospital

Investigators

  • Study Chair: NAVEEN NARAYAN, MS, MCh, Adichunchanagiri Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2025

Primary Completion (Actual)

February 13, 2026

Study Completion (Actual)

February 21, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMS/IEC/266/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data and statistical code will be available upon reasonable request after publication of results.

IPD Sharing Time Frame

6 months post-publication

IPD Sharing Access Criteria

De-identified individual participant data will be made available to investigators upon reasonable request beginning 6 months after publication. Access will be granted to researchers who provide a methodologically sound proposal and agree to use the data only for research purposes. Researchers must sign a data access agreement. The Study Protocol and Statistical Analysis Plan (SAP) will also be shared 6 months post-publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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