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
Adichunchanagiri Institute of Medical Sciences, B G Nagara
60 participants
Oct 20, 2025
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
Inclusion Criteria4
- 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 Criteria4
- Collagen allergy or active infection
- Immunosuppression or chronic steroid use
- Pregnancy/lactation
- Uncontrolled sepsis, bowel perforation, or extensive small bowel resection
Interventions
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.
Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07241091