An interventional study of High-Purity Type-I Collagen Scaffold and Standard Peritonectomy Closure in Peritoneal Surface Malignancy, Postoperative Adhesion and Bowel Obstruction, sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. Completed at 2 sites in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara · Not applicable, Interventional, and Treatment
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
249 studies on the registry are indexed under Peritoneal Neoplasms; 55 are open to participants now.
This study's enrollment of 60 is above the median of 46 across 202 interventional studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →Adichunchanagiri Institute of Medical Sciences, B G Nagara is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: High-Purity Type-I Collagen Scaffold
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.
Procedure: Standard Peritonectomy Closure
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.
Incidence 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 Intensive Care Unit Stay
Duration of postoperative intensive care unit stay following cytoreductive surgery.
Time frame: During index hospitalization
Length of Hospital Stay
Total duration of hospitalization following cytoreductive surgery.
Time frame: During index hospitalization
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: Within 2 months after surgery
MRI-Detected Intra-Abdominal Adhesions
Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.
Time frame: Within 2 months after surgery
Change in Quality of Life Domains (EORTC QLQ-C30)
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
Time frame: Baseline to 2 months after surgery
| Milestone | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery
| Participants | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Incidence of Major Intra-abdominal Complications | 4 | 11 |
Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)
| Participants | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Adhesive small bowel obstruction | 1 | 8 |
| Enterocutaneous fistula | 0 | 3 |
| Surgical site infection | 1 | 3 |
| Incisional hernia (early) | 0 | 2 |
| MRI-detected dense adhesions | 3 | 12 |
Time to bowel function recovery and diet tolerance
| days | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Time to Bowel Function Recovery | 4.2 ± 1.7 | 6.1 ± 2.4 |
Duration of postoperative intensive care unit stay following cytoreductive surgery.
| days | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Length of Intensive Care Unit Stay | 1.9 ± 1.1 | 3.1 ± 1.4 |
Total duration of hospitalization following cytoreductive surgery.
| days | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Length of Hospital Stay | 9.8 ± 2.6 | 13.4 ± 3.1 |
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.
| Participants | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Device-related Adverse Events | 0 | 0 |
Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.
| Participants | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| MRI-Detected Intra-Abdominal Adhesions | 3 | 12 |
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
| score on a scale | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Global health status | 18.6 ± 7.4 | 9.2 ± 6.8 |
| Physical functioning | 15.1 ± 6.9 | 8.3 ± 7.1 |
| Pain (symptom scale) | 21.4 ± 8.1 | 11.7 ± 7.9 |
Collected over From surgery to 2 months postoperative follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Purity Type-I Collagen-based Peritoneal Substitute | 0/30 (0%) | 0/30 (0%) | 2/30 (6.7%) |
| Standard Peritonectomy Closure | 0/30 (0%) | 6/30 (20%) | 16/30 (53.3%) |
| Event | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Reoperation for intra-abdominal complicationSurgical and medical procedures | 0/30 | 6/30 |
| Event | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure |
|---|---|---|
| Adhesive small bowel obstructionGastrointestinal disorders | 1/30 | 8/30 |
| Enterocutaneous fistulaGastrointestinal disorders | 0/30 | 3/30 |
| Surgical site infectionSkin and subcutaneous tissue disorders | 1/30 | 3/30 |
| Early incisional herniaMusculoskeletal and connective tissue disorders | 0/30 | 2/30 |
| Age, Continuous(years) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Mean | 54.6 ± 9.8 | 56.1 ± 10.2 | 55.4 ± 10.0 |
| Sex: Female, Male(Participants) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Female | 13 | 14 | 27 |
| Male | 17 | 16 | 33 |
| Race and Ethnicity Not Collected(Participants) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| India | 30 | 30 | 60 |
| ECOG Performance Status 0-1(Participants) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Count of participants | 26 | 25 | 51 |
| Primary Malignancy Type(Participants) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Colorectal cancer | 12 | 11 | 23 |
| Ovarian cancer | 9 | 10 | 19 |
| Other peritoneal surface malignancies | 9 | 9 | 18 |
| Peritoneal Cancer Index (PCI)(score on a scale) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Mean | 17.8 ± 4.9 | 18.3 ± 5.2 | 18.1 ± 5.0 |
| HIPEC Performed(Participants) | High Purity Type-I Collagen-based Peritoneal Substitute | Standard Peritonectomy Closure | Total |
|---|---|---|---|
| Count of participants | 21 | 22 | 43 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data and statistical code will be available upon reasonable request after publication of results.
Supporting information: Study protocol, Statistical analysis plan
Time frame: 6 months post-publication
Access criteria: De-identified individual participant data will be made available to investigators upon reasonable request beginning 6 months after publication. Access will be granted to researchers who provide a methodologically sound proposal and agree to use the data only for research purposes. Researchers must sign a data access agreement. The Study Protocol and Statistical Analysis Plan (SAP) will also be shared 6 months post-publication.
Ran from Oct 2025 to primary completion in Feb 2026, 3 months.
Results were first posted in Mar 2026, 1 month after primary completion.
Of 34 interventional studies with no phase under Peritoneal Neoplasms, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 80. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Adichunchanagiri Institute of Medical Sciences, B G Nagara