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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
RECRUITINGJSS Medical College Hospital
Mysore, Karnataka, India
RECRUITINGIncidence of major intra-abdominal complications
Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery
Time frame: 2 months post-surgery
Individual complication rates
Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)
Time frame: 2 months
Time to bowel function recovery
Time to bowel function recovery and diet tolerance
Time frame: 1 month
Length of hospital and ICU stay
Duration (in days) from the date of surgery until discharge from the hospital, including the number of days spent in the ICU. This will capture differences in postoperative recovery and resource utilization between groups.
Time frame: 2 months
Device-related adverse events
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: 2 months
Quality of life Assessment
Quality of life assessment using the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire includes multiple subscales scored from 0 to 100. For functional scales and global health status, higher scores indicate better quality of life; for symptom scales, higher scores indicate worse symptoms.
Time frame: 2 months
Number of participants with MRI-detected intra-abdominal adhesions or obstruction
Radiologic assessment of intra-abdominal adhesions, bowel obstruction, or other postoperative abnormalities on MRI at baseline, 1 month, and 2 months. The number of participants demonstrating each finding will be recorded.
Time frame: 2 months
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