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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
India
Adichunchanagiri Institute of Medical Sciences
RECRUITING
Mandya
JSS Medical College Hospital
RECRUITING
Mysore
Contact Information
Primary
Rajesh K Nanjundaiah, MBBS, MS
naveen_uno1@yahoo.co.in
+91-9986418503
Backup
Pallavi H Raghavendra, MBBS, MS
hr.pragna@gmail.com
+91-9986629321
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: JSS Medical College Hospital
Leads: Adichunchanagiri Institute of Medical Sciences, B G Nagara