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

NCT07241091 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-30

Study results available
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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.

Conditions

  • Peritoneal Surface Malignancy
  • Postoperative Adhesion
  • Bowel Obstruction
  • Wound Complications
  • Surgical Site Infection After Major Surgery
  • Ovarian Cancer (OvCa)

Interventions

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.

PROCEDURE

Standard Peritonectomy Closure

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

Sponsors & Collaborators

  • JSS Medical College Hospital

    collaborator UNKNOWN

  • Adichunchanagiri Institute of Medical Sciences, B G Nagara

    lead OTHER

Principal Investigators

  • NAVEEN NARAYAN, MS, MCh · Adichunchanagiri Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-02-13
Completion
2026-02-21

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07241091 on ClinicalTrials.gov