NCT00647569已完成3 期
Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- incisional hernia formation determined by CT scan 1 year postoperative
研究概览
简要总结
The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.
排除标准
- •Pre or perioperative knowledge of disseminated malignancy
- •Unable to follow the control program
- •Known allergy to pig
- •Compromised immune defense
- •Artificial heart valve or recent (< 3 months) implanted foreign body
- •Age < 18 years
研究组 & 干预措施
B
Experimental
Previous major abdominal surgery
干预措施: Mesh repair (Procedure)
A
Experimental
No previous major abdominal surgery
干预措施: Conventional facial closure (Procedure)
B
Experimental
Previous major abdominal surgery
干预措施: Conventional facial closure (Procedure)
A
Experimental
No previous major abdominal surgery
干预措施: Mesh repair (Procedure)
结局指标
主要结局
incisional hernia formation determined by CT scan 1 year postoperative
时间窗: 1 year postoperative
次要结局
- postoperative morbidity(30 days postoperative)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Biologic Mesh Versus Synthetic Mesh in Repair of Ventral HerniasVentral HerniaNCT02451176Michael Rosen253
已完成
不适用
Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma FormationHerniaNCT00577603Mayo Clinic40
已完成
不适用
Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCPIntestinal ObstructionPelvic Organ ProlapseRectal ProlapseNCT06245577Evangelisches Klinikum Köln Weyertal gGmbH30
Unknown
4 期
Biologic Versus Synthetic Mesh for Treatment of Paraesophageal HerniaHiatal HerniaNCT02242526Stony Brook University312
终止
不适用
Endoscopic Mucosal Resection and Cellular MatrixBarretts Esophagus With High Grade DysplasiaBarrett AdenocarcinomaNCT03240679Mayo Clinic3