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

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Enrolling

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

Treatments: Device: High-Purity Type-I Collagen Scaffold; Procedure: Standard Peritonectomy Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07241091

AIMS/IEC/266/2025

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

High Purity Type-I Collagen-based Peritoneal Substitute

Active Comparator group

Description:

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.

Treatment:

Device: High-Purity Type-I Collagen Scaffold

Standard Peritonectomy Closure

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Peritonectomy Closure