N/A
Completed N=60
SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery
Peritoneal Surface Malignancy · Postoperative Adhesion · Bowel Obstruction · Wound Complications
Source: ClinicalTrials.gov NCT07241091 ↗
Enrolled (actual)
60
Serious AEs
10.0%
Results posted
Mar 2026
Primary outcomePrimary: Incidence of Major Intra-abdominal Complications — 4; 11 Participants
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.
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 | — |
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
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. Informational only — not medical advice.