RecruitingNot ApplicableNCT07241091

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

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


Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Enrollment

60 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a high-purity collagen patch (SurgiPerito) used to rebuild the lining of the abdominal cavity (peritoneum) after extensive cancer-removal surgery, with the goal of reducing complications and improving healing. **You may be eligible if...** - You are 18 years or older with cancer that has spread to the lining of the abdomen (peritoneal surface cancers — such as colorectal, ovarian, appendiceal, mesothelioma, or pseudomyxoma) - You are undergoing cytoreductive surgery (surgery to remove as much tumor as possible), with or without heated chemotherapy (HIPEC), that requires removal of some of the abdominal lining - You are in reasonable health (ECOG 0–2) with adequate organ function **You may NOT be eligible if...** - You have a known allergy to collagen - You have an active infection - You are on long-term steroids or immune-suppressing medications - You are pregnant or breastfeeding - You have uncontrolled sepsis, a bowel rupture, or major small bowel removal during surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-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.

PROCEDUREStandard Peritonectomy Closure

Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.


Locations(2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India

JSS Medical College Hospital

Mysore, Karnataka, India

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NCT07241091


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