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
Phase: NA
Conditions: Peritoneal Surface Malignancy, Postoperative Adhesion, Bowel Obstruction, Wound Complications, Surgical Site Infection After Major Surgery, Ovarian Cancer (OvCa)
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara

Title: SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal 
Reconstruction After Cytoreductive Surgery 
 
NCT No: NCT07241091 
 
 
Date: March 03, 2026 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

INTRODUCTION 
Peritoneal surface malignancies (PSMs), arising from primary tumors such as colorectal carcinoma, 
ovarian cancer, appendiceal neoplasms, malignant peritoneal mesothelioma, and pseudomyxoma 
peritonei, represent a challenging oncologic condition associated with significant morbidity and 
historically poor survival outcomes. Over the last two decades, cytoreductive surgery (CRS), with or 
without hyperthermic intraperitoneal chemotherapy (HIPEC), has emerged as a standard-of-care 
strategy in selected patients, demonstrating improved overall and disease-free survival when complete 
cytoreduction is achieved [1–3]. 
CRS frequently necessitates extensive peritonectomy to remove macroscopic tumor deposits. While 
oncologically effective, peritonectomy disrupts the native peritoneal lining, a specialized mesothelial 
surface responsible for frictionless visceral movement, immunologic defense, fluid homeostasis, and 
rapid tissue repair [4]. Loss of this biological barrier predisposes patients to a spectrum of 
postoperative complications, including dense intra-abdominal adhesions, adhesive small bowel 
obstruction, prolonged postoperative ileus, enterocutaneous fistula formation, surgical site infection, 
incisional hernia, and the need for reoperation [5–7]. These complications significantly prolong 
hospital stay, delay adjuvant oncologic therapies, impair quality of life, and increase overall 
healthcare utilization. 
At present, there is no universally accepted standard for peritoneal reconstruction following 
peritonectomy. Conventional surgical practice typically involves leaving the peritoneal defect 
untreated, allowing secondary healing through fibrosis. However, this process is often disorganized 
and pro-inflammatory, promoting excessive fibrin deposition and adhesion formation rather than 
structured regeneration of a functional mesothelial layer [8]. Consequently, there has been increasing 
interest in biologic materials that can serve as temporary peritoneal substitutes, restoring anatomic 
continuity while modulating the wound-healing response. 
High-purity Type I collagen (HPTC)–based biomaterials have demonstrated favorable biological and 
mechanical properties across a range of reconstructive and regenerative surgical applications. 
Collagen, the principal structural protein of the extracellular matrix, plays a critical role in cellular 
adhesion, angiogenesis, and tissue remodeling. When processed through stringent purification 
protocols, HPTC scaffolds are biocompatible, minimally immunogenic, and bioresorbable, providing 
a three-dimensional framework that supports orderly tissue regeneration rather than scar-driven 
fibrosis [9–11]. 
In abdominal and reconstructive surgery, collagen-based matrices have been shown to reduce 
infection rates, improve integration in contaminated fields, and promote functional tissue repair. Prior 
studies evaluating biological meshes in the context of complex abdominal wall reconstruction during 
CRS have demonstrated acceptable safety profiles and encouraging clinical outcomes [12]. 
Additionally, emerging clinical evidence from wound care and soft tissue reconstruction has shown 

that HPTC-based scaffolds can significantly reduce complication rates and enhance healing outcomes 
when compared with alternative biological substitutes [13–16]. 
Surgicoll-Mesh® is a sterile, resorbable, high-purity Type I collagen–based biomaterial designed to 
function as a temporary regenerative scaffold [17]. When used as a peritoneal substitute following 
peritonectomy, it is hypothesized to provide a protective barrier between visceral surfaces, reduce 
fibrin-mediated adhesion formation, and facilitate organized neo-peritoneal regeneration during the 
critical early postoperative period. Despite strong biological plausibility and supportive evidence from 
related surgical domains, high-quality prospective randomized data evaluating collagen-based 
peritoneal substitutes in patients undergoing CRS for intraperitoneal malignancy remain limited. 
Given the substantial morbidity associated with post-peritonectomy complications and the absence of 
standardized reconstructive strategies, there exists a clear unmet clinical need for interventions that 
enhance intra-abdominal healing without compromising oncologic safety. This need is particularly 
relevant in resource-conscious healthcare systems, where reducing postoperative complications has 
direct implications for patient outcomes and system sustainability. 
Accordingly, this prospective, multicenter, randomized controlled trial was designed to evaluate the 
safety and efficacy of Surgicoll-Mesh® as a peritoneal substitute following peritonectomy in patients 
undergoing CRS for intraperitoneal malignancies. The primary objective was to determine whether 
the use of a high-purity Type I collagen scaffold reduces the incidence of major postoperative intra-
abdominal complications compared with standard peritonectomy closure. Secondary objectives 
included assessment of individual complication rates, bowel function recovery, length of hospital and 
intensive care stay, device-related adverse events, radiologic evidence of adhesions, and patient-
reported quality of life outcomes using a validated instrument. 
 
MATERIALS AND METHODS 
Study Design and Setting 
This study was designed as a prospective, multicenter, open-label, randomized controlled clinical trial 
evaluating the safety and efficacy of a high-purity Type I collagen–based biomaterial (Surgicoll-
Mesh®) as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive 
surgery (CRS) for intraperitoneal malignancies. The trial was conducted at two tertiary referral 
centers specializing in oncologic and reconstructive surgery. 
The trial was conducted at two tertiary oncology referral centers – JSS Academy of Higher Education 
and Research, Mysuru and Adichunchangiri Institute of Medical Sciences, B G Nagara. The trial was 
registered prospectively with ClinicalTrials.gov (ID: NCT07241091) and approved by the 
Institutional Ethics Committee (Approval No.: AIMS/IEC/266/2025). The study was conducted in 
accordance with the principles of the Declaration of Helsinki, Good Clinical Practice (GCP) 
guidelines, and Consolidated Standards of Reporting Trials (CONSORT) recommendations [18]. 

Institutional Ethics Committee approval was obtained at all participating centers prior to patient 
enrollment. 
 
Study Population 
Patients were consecutively screened for eligibility during multidisciplinary tumor board evaluation at 
participating centers. Adults aged 18–75 years with histologically confirmed peritoneal surface 
malignancy (including colorectal, ovarian, appendiceal, pseudomyxoma peritonei, or malignant 
peritoneal mesothelioma) scheduled to undergo cytoreductive surgery with anticipated peritonectomy, 
with or without hyperthermic intraperitoneal chemotherapy, were considered eligible. Additional 
inclusion criteria included Eastern Cooperative Oncology Group (ECOG) performance status 0–2 
[19], adequate hematologic, renal, and hepatic function, and ability to provide written informed 
consent.  
Exclusion criteria comprised known hypersensitivity to collagen-based products, active intra-
abdominal infection or uncontrolled sepsis, chronic immunosuppression or long-term systemic 
corticosteroid therapy, pregnancy or lactation, extensive small-bowel resection precluding safe 
reconstruction, and emergency surgery or bowel perforation at presentation. 
 
 
Randomization and Allocation 
Eligible patients were randomized in a 1:1 ratio to either the intervention group (HPTC peritoneal 
reconstruction) or the control group (standard peritonectomy closure). Randomization was performed 
using a computer-generated block randomization sequence with variable block sizes to ensure 
balanced group allocation across participating centers. 
Allocation concealment was achieved using sealed, opaque envelopes opened intraoperatively after 
completion of cytoreduction and confirmation of peritoneal defect suitability. Due to the nature of the 
surgical intervention, blinding of the operating surgeon was not feasible. However, outcome 
assessors, radiologists evaluating imaging studies, and statisticians were blinded to treatment 
allocation wherever applicable. 
 
Surgical Procedure and Intervention 
Cytoreductive Surgery and Peritonectomy 
All patients underwent CRS performed by experienced surgical oncologists following standardized 
institutional protocols. The goal of CRS was complete or near-complete macroscopic tumor clearance 
(CC-0 or CC-1 resection). Peritonectomy procedures were carried out as required based on disease 
distribution and included parietal and/or visceral peritoneal stripping. 
The use of HIPEC was permitted and performed according to tumor-specific protocols but was evenly 
distributed between study arms. 

 
Intervention Group: HPTC Peritoneal Reconstruction 
In patients randomized to the intervention arm, peritoneal defects created following peritonectomy 
were reconstructed using HPTC (Surgicoll-Mesh®), a sterile, resorbable, high-purity Type I collagen 
scaffold. The mesh was tailored intraoperatively to match the dimensions of the peritoneal defect and 
secured using interrupted absorbable sutures to adjacent tissue margins prior to abdominal closure. 
The biomaterial was applied without tension and without overlap onto visceral organs. 
The mesh was intended to function as a temporary biologic barrier and regenerative scaffold, 
facilitating organized tissue remodeling during the early postoperative period [9–11]. 
 
Control Group: Standard Peritonectomy Closure 
Patients allocated to the control arm underwent standard peritonectomy closure without the use of any 
peritoneal substitute or biomaterial. Peritoneal defects were left untreated, allowing secondary healing 
according to standard institutional practice. 
 
Postoperative Care and Follow-Up 
Postoperative management protocols, including analgesia, antibiotic prophylaxis, early mobilization, 
and nutritional advancement, were standardized across centers. Nasogastric decompression was 
discontinued at the discretion of the treating team based on bowel function recovery. 
Patients were followed for a minimum of two months postoperatively, with scheduled clinical 
assessments at discharge, 30 days, and 60 days. Imaging studies and quality-of-life assessments were 
performed according to protocol-defined timelines. 
 
Outcome Measures 
Primary Outcome 
The primary outcome was the incidence of major intra-abdominal complications within two months 
following surgery. Major complications were predefined as: 
• 
Adhesive small bowel obstruction requiring intervention 
• 
Enterocutaneous fistula 
• 
Reoperation for intra-abdominal complication 
• 
Grade ≥3 wound complications based on the Clavien–Dindo classification 
 
Secondary Outcomes 
Secondary outcomes included: 
• 
Individual complication rates, including intraperitoneal adhesions, bowel obstruction, surgical 
site infection, incisional hernia, and fistula formation 

• 
Time to bowel function recovery, defined as the time to first flatus and tolerance of oral diet 
• 
Length of intensive care unit (ICU) stay and total hospital stay 
• 
Device-related adverse events, including infection, inflammatory reaction, or mesh-related 
complications 
• 
Radiologic assessment of adhesions or obstruction using magnetic resonance imaging (MRI) 
at baseline, one month, and two months 
• 
Quality of life assessment using the European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), a validated cancer-
specific instrument [20] 
 
Sample Size Calculation 
Based on prior literature reporting postoperative complication rates of approximately 40–45% 
following extensive peritonectomy, a reduction to 15–20% in the intervention group was considered 
clinically meaningful. The required sample size for comparing two independent proportions was 
estimated using the formula: 
n = ((Z1−α/2 + Z1−β)² × [p1(1−p1) + p2(1−p2)]) / (p1−p2)² 
where p1  represents the expected complication rate in the control group and p2 the expected rate in the 
intervention group, Z1−α/2 corresponds to the two-sided significance level α=0.05, and Z1−β to the 
desired power (80%). Assuming p1=0.40 and p2=0.20, the calculated minimum sample size was 26 
patients per group. To account for potential dropouts and protocol deviations, 30 patients were 
enrolled in each arm, yielding a total sample size of 60 participants.  
 
Statistical Analysis Plan 
Statistical analyses were performed using SPSS version 29.0 (IBM Corp., Armonk, NY, USA). 
Continuous variables were assessed for normality using the Shapiro–Wilk test and are presented as 
mean ± standard deviation for normally distributed data or median with interquartile range for non-
normally distributed data. Between-group comparisons were conducted using the independent t-test or 
Mann–Whitney U test for continuous variables and the chi-square test or Fisher’s exact test for 
categorical variables, as appropriate. Effect estimates for the primary and key secondary binary 
outcomes were expressed as relative risks with 95% confidence intervals. Time-to-event outcomes, 
including time to bowel function recovery, were analyzed using Kaplan–Meier survival curves with 
log-rank testing. Multivariable logistic regression analysis was performed to adjust for potential 
confounders, including age, primary tumor type, peritoneal cancer index score, and use of 
hyperthermic intraperitoneal chemotherapy. All statistical tests were two-sided, and a p-value < 0.05 
was considered statistically significant. Analyses were conducted on an intention-to-treat basis. 
 

Data Management and Ethical Considerations 
All data were prospectively collected using standardized case report forms and anonymized prior to 
analysis. Data integrity was ensured through regular monitoring and cross-verification. The study 
included a predefined plan for de-identified individual participant data (IPD) sharing upon reasonable 
request following publication. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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