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临床试验/NCT07241091
NCT07241091招募中不适用

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

Adichunchanagiri Institute of Medical Sciences, B G Nagara4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
4
主要终点
Incidence of major intra-abdominal complications

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Collagen allergy or active infection
  • Immunosuppression or chronic steroid use
  • Pregnancy/lactation
  • Uncontrolled sepsis, bowel perforation, or extensive small bowel resection

结局指标

主要结局

Incidence of major intra-abdominal complications

时间窗: 2 months post-surgery

Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery

次要结局

  • Quality of life Assessment(2 months)
  • Individual complication rates(2 months)
  • Time to bowel function recovery(1 month)
  • Length of hospital and ICU stay(2 months)
  • Device-related adverse events(2 months)
  • Quality of life Assessment(2 months)
  • Number of participants with MRI-detected intra-abdominal adhesions or obstruction(2 months)

研究者

发起方
Adichunchanagiri Institute of Medical Sciences, B G Nagara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Naveen Narayan MS, MCh (Plastic Surgery)

Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Adichunchanagiri Institute of Medical Sciences, B G Nagara

研究点 (4)

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