N/A N=60 Randomized Treatment

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

Peritoneal Surface Malignancy · Postoperative Adhesion · Bowel Obstruction · Wound Complications · Surgical Site Infection After Major Surgery

Bottom Line

View on ClinicalTrials.gov: NCT07241091 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Mar 2026

Primary outcome: Primary: Incidence of Major Intra-abdominal Complications — 4; 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High-Purity Type-I Collagen Scaffold (Device); Standard Peritonectomy Closure (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Primary completion: Feb 2026

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Major Intra-abdominal Complications	4; 11	—
SECONDARY Individual Complication Rates	1; 8; 0; 3; 1; 3	—
SECONDARY Time to Bowel Function Recovery	4.2; 6.1	—
SECONDARY Length of Intensive Care Unit Stay	1.9; 3.1	—
SECONDARY Length of Hospital Stay	9.8; 13.4	—
SECONDARY Device-related Adverse Events	0; 0	—
SECONDARY MRI-Detected Intra-Abdominal Adhesions	3; 12	—
SECONDARY Change in Quality of Life Domains (EORTC QLQ-C30)	18.6; 9.2; 15.1; 8.3; 21.4; 11.7	—

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07241091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.