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
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
- 否
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
Dr Naveen Narayan MS, MCh (Plastic Surgery)
Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery
Adichunchanagiri Institute of Medical Sciences, B G Nagara