Bowel Obstruction, Ovarian Cancer (OvCa), Peritoneal Surface Malignancy, Postoperative Adhesion, Surgical Site Infection After Major Surgery, Wound Complications
Conditions
Keywords
High-Purity Type-I Collagen, Collagen Biomaterial, Peritonectomy, Cytoreductive Surgery (CRS), Peritoneal Substitute, Adhesion Prevention, Peritoneal Reconstruction, Regenerative Collagen Matrix, HIPEC (Hyperthermic Intraperitoneal Chemotherapy), Intra-abdominal Healing
Brief 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.
Detailed description
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
Interventions
DEVICEHigh-Purity Type-I Collagen Scaffold
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.
PROCEDUREStandard Peritonectomy Closure
Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
JSS Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Intra-abdominal Complications | 2 months post-surgery | Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual Complication Rates | 2 months | Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula) |
| Time to Bowel Function Recovery | 1 month | Time to bowel function recovery and diet tolerance |
| Length of Intensive Care Unit Stay | During index hospitalization | Duration of postoperative intensive care unit stay following cytoreductive surgery. |
| Length of Hospital Stay | During index hospitalization | Total duration of hospitalization following cytoreductive surgery. |
| Device-related Adverse Events | 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. |
| MRI-Detected Intra-Abdominal Adhesions | Within 2 months after surgery | Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging. |
| Change in Quality of Life Domains (EORTC QLQ-C30) | 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 |
Countries
India
Contacts
STUDY_CHAIRNAVEEN NARAYAN, MS, MCh
Adichunchanagiri Institute of Medical Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 9.8 |
| Completeness of Cytoreduction (CC Score) CC-0 / CC-1 cytoreduction achieved | 27 Participants |
| Completeness of Cytoreduction (CC Score) Less than CC-1 cytoreduction | 3 Participants |
| ECOG Performance Status 0-1 | 25 Participants |
| HIPEC Performed | 21 Participants |
| Peritoneal Cancer Index (PCI) | 18.3 score on a scale STANDARD_DEVIATION 5.2 |
| Primary Malignancy Type Colorectal cancer | 11 Participants |
| Primary Malignancy Type Other peritoneal surface malignancies | 18 Participants |
| Primary Malignancy Type Ovarian cancer | 10 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment India | 30 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 16 / 30 |
| serious Total, serious adverse events | 0 / 30 | 6 / 30 |
Outcome results
None listed