NCT Number: NCT07241091
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Adichunchanagiri Institute of Medical Sciences, Mandya, Karnataka, India
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 months post-surgery
Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery
Time frame: 2 months
Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)
Time frame: 1 month
Time to bowel function recovery and diet tolerance
Time frame: During index hospitalization
Duration of postoperative intensive care unit stay following cytoreductive surgery.
Time frame: During index hospitalization
Total duration of hospitalization following cytoreductive surgery.
Time frame: Within 2 months after surgery
Any adverse event deemed related to the implanted High-Purity Type-I Collagen biomaterial, including mesh reaction, infection, seroma, rejection, or need for mesh removal, assessed within the 2-month postoperative period.
Time frame: Within 2 months after surgery
Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.
Time frame: Baseline to 2 months after surgery
Change from baseline in quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale.
For global health and functional scales, higher scores indicate better outcomes and higher change values represent improvement.
For pain (symptom scales), higher scores indicate worse symptoms; therefore, reductions from baseline represent improvement
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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