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临床试验/NCT04137172
NCT04137172已完成不适用

Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia. A Randomized Controlled Trial

Zagazig University1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2016年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
1
主要终点
post operative complications

研究概览

简要总结

entral hernias are a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5 % in the literature, and ventral incisional hernia rates vary from 35 to 60 % within 5 years after laparotomy . After laparoscopy, this rate is estimated to decline from 0.5 to 15 % even after two decades, LVHR or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position. . The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with IPOM reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • patients over 18 years undergoing surgery for primary or incisional ventral hernia
  • defect whose major axis not exceeding 12cm.

排除标准

  • Patients undergoing revision
  • Emergency surgery.
  • Parastomal hernias were not included.
  • Patients not candidate for laparoscopy including cardiac and COPD patients

结局指标

主要结局

post operative complications

时间窗: 6 months

Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery

次要结局

  • Surgical Site Occurrence (SSO)(6 months to one year)
  • Hernia Reoccurence(6 months to one year)
  • adequacy of different techniques(6 months to one year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

osama khalil

assistant profeosser

Zagazig University

研究点 (1)

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