跳至主要内容
临床试验/NCT04419844
NCT04419844Unknown不适用

Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .

Mansoura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Recurrence

研究概览

简要总结

Aim of the work In this study, we will evaluate posterior component separation (TAR) technique with or without Botox injection for open huge ventral hernia and large abdominal wall defect repair. The primary outcome will be recurrence while the secondary outcome will be infection, postoperative complications (bleeding and dehiscence), pain score, operative time, hospitalization, need for drain, time for drain removal and pulmonary function test before and after surgery.

This prospective clinical study will be performed on 40 eligible patients admitted to general surgery department at Mansoura University Hospi

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
12 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patient fit for general anesthesia with huge ventral hernia (primary, incisional or recurrent).Any patient with large abdominal wall defect secondary to abdominal wall tumor excision or burst after surgery

排除标准

  • •Patients who are unfit for general anaesthesia. Poor pulmonary function tests. Pregnant females. Patient younger than 18 years. Immunodeficiency. Patient with psychiatric disease disabling surgical intervention. Patients who refuse to participate in our study.

研究组 & 干预措施

TAR with Botox

Active Comparator

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection .

干预措施: Tar with Botox (Procedure)

TAR without Botox

Active Comparator

Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection .

干预措施: Tar with Botox (Procedure)

结局指标

主要结局

Recurrence

时间窗: one year

Recurrence of the ventral hernia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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