Trial Outcomes & Findings for SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery (NCT NCT07241091)
NCT ID: NCT07241091
Last Updated: 2026-03-30
Results Overview
Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
2 months post-surgery
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 9.8 • n=30 Participants
|
56.1 years
STANDARD_DEVIATION 10.2 • n=30 Participants
|
55.4 years
STANDARD_DEVIATION 10.0 • n=60 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
27 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
33 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
|
ECOG Performance Status 0-1
|
26 Participants
n=30 Participants
|
25 Participants
n=30 Participants
|
51 Participants
n=60 Participants
|
|
Primary Malignancy Type
Colorectal cancer
|
12 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
23 Participants
n=60 Participants
|
|
Primary Malignancy Type
Ovarian cancer
|
9 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Primary Malignancy Type
Other peritoneal surface malignancies
|
9 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
18 Participants
n=60 Participants
|
|
Peritoneal Cancer Index (PCI)
|
17.8 score on a scale
STANDARD_DEVIATION 4.9 • n=30 Participants
|
18.3 score on a scale
STANDARD_DEVIATION 5.2 • n=30 Participants
|
18.1 score on a scale
STANDARD_DEVIATION 5.0 • n=60 Participants
|
|
HIPEC Performed
|
21 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
43 Participants
n=60 Participants
|
|
Completeness of Cytoreduction (CC Score)
CC-0 / CC-1 cytoreduction achieved
|
28 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
55 Participants
n=60 Participants
|
|
Completeness of Cytoreduction (CC Score)
Less than CC-1 cytoreduction
|
2 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 2 months post-surgeryIncidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Incidence of Major Intra-abdominal Complications
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 monthsIndividual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Individual Complication Rates
Enterocutaneous fistula
|
0 Participants
|
3 Participants
|
|
Individual Complication Rates
Adhesive small bowel obstruction
|
1 Participants
|
8 Participants
|
|
Individual Complication Rates
Surgical site infection
|
1 Participants
|
3 Participants
|
|
Individual Complication Rates
Incisional hernia (early)
|
0 Participants
|
2 Participants
|
|
Individual Complication Rates
MRI-detected dense adhesions
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 monthTime to bowel function recovery and diet tolerance
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Time to Bowel Function Recovery
|
4.2 days
Standard Deviation 1.7
|
6.1 days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: During index hospitalizationDuration of postoperative intensive care unit stay following cytoreductive surgery.
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Length of Intensive Care Unit Stay
|
1.9 days
Standard Deviation 1.1
|
3.1 days
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: During index hospitalizationTotal duration of hospitalization following cytoreductive surgery.
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Length of Hospital Stay
|
9.8 days
Standard Deviation 2.6
|
13.4 days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Within 2 months after surgeryPopulation: Patients undergoing cytoreductive surgery with peritonectomy did not have device, which is being evaluated in the study,
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.
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Device-related Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 2 months after surgeryNumber of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
MRI-Detected Intra-Abdominal Adhesions
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline to 2 months after surgeryChange 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
Outcome measures
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 Participants
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 Participants
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Change in Quality of Life Domains (EORTC QLQ-C30)
Global health status
|
18.6 score on a scale
Standard Deviation 7.4
|
9.2 score on a scale
Standard Deviation 6.8
|
|
Change in Quality of Life Domains (EORTC QLQ-C30)
Physical functioning
|
15.1 score on a scale
Standard Deviation 6.9
|
8.3 score on a scale
Standard Deviation 7.1
|
|
Change in Quality of Life Domains (EORTC QLQ-C30)
Pain (symptom scale)
|
21.4 score on a scale
Standard Deviation 8.1
|
11.7 score on a scale
Standard Deviation 7.9
|
Adverse Events
High Purity Type-I Collagen-based Peritoneal Substitute
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Peritonectomy Closure
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 participants at risk
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 participants at risk
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Surgical and medical procedures
Reoperation for intra-abdominal complication
|
0.00%
0/30 • From surgery to 2 months postoperative follow-up
|
20.0%
6/30 • Number of events 6 • From surgery to 2 months postoperative follow-up
|
Other adverse events
| Measure |
High Purity Type-I Collagen-based Peritoneal Substitute
n=30 participants at risk
Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
High-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.
|
Standard Peritonectomy Closure
n=30 participants at risk
Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
|
|---|---|---|
|
Gastrointestinal disorders
Adhesive small bowel obstruction
|
3.3%
1/30 • Number of events 1 • From surgery to 2 months postoperative follow-up
|
26.7%
8/30 • Number of events 8 • From surgery to 2 months postoperative follow-up
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/30 • From surgery to 2 months postoperative follow-up
|
10.0%
3/30 • Number of events 3 • From surgery to 2 months postoperative follow-up
|
|
Skin and subcutaneous tissue disorders
Surgical site infection
|
3.3%
1/30 • Number of events 1 • From surgery to 2 months postoperative follow-up
|
10.0%
3/30 • Number of events 3 • From surgery to 2 months postoperative follow-up
|
|
Musculoskeletal and connective tissue disorders
Early incisional hernia
|
0.00%
0/30 • From surgery to 2 months postoperative follow-up
|
6.7%
2/30 • Number of events 2 • From surgery to 2 months postoperative follow-up
|
Additional Information
Prof Naveen Narayan
Adichunchanagiri Institute of Medical Sciences
Phone: +91-9980023372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place