Effect of Duramesh™ on Hernia Formation After Ileostomy Closure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- hernia rates
研究概览
简要总结
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)
- •Age 18 or greater
- •Surgical oncology patient where routine radiologic surveillance for malignancy is planned
- •Patient accepts participation and gives informed consent
排除标准
- •• Pregnancy
- •Prior mesh hernia repair at laparotomy site
- •Life expectancy less than 1 years
- •Patient is unable / unwilling to provide informed consent
- •Patient is unable to comply with the protocol or proposed follow-up visits
- •Patient is enrolled in another hernia study
- •Non-English-speaking participants
- •Data from children will not analyzed in this study.
- •Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
- •Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.
研究组 & 干预措施
Duramesh
using duramesh suture for ileostomy fascial closure
干预措施: duramesh (Device)
Control
standard ileostomy fascial closure
干预措施: Control (Device)
结局指标
主要结局
hernia rates
时间窗: 1 year
Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure
次要结局
- infection rate(1 year)
研究者
Vitaliy Poylin
Director, Section of Colon and Rectal Surgery
Northwestern University