跳至主要内容
临床试验/CTRI/2019/05/019115
CTRI/2019/05/019115尚未招募不适用

To Compare absorbable versus non absorbable tacker for laparoscopy ventral hernia repair.a prospective randomised study.

Department of General Surgery1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Patient comfort in post-operative period (measured by Visual Analog Scale for post operative pain)

研究概览

简要总结

In this study regarding laparoscopic ventral hernia repair - 2 groups of 30 patients each (total sample size-60) ,selected randomly will be compared in terms of hernia repair by using absorbable vs nonabsorbable tackers. 

Outcome in terms of  post operative pain,hospital stay,recurrence rate,post operative complication.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All the patients between 18 to 65 year age with uncomplicated ventral hernia.

排除标准

  • infants and children(<18 years),patients with large irreducible hernia,strangulated hernia,patients unfit for general anaesthesia due to any reason.

结局指标

主要结局

Patient comfort in post-operative period (measured by Visual Analog Scale for post operative pain)

时间窗: 7 day,1 month,3 month,6 month

Post operative complications

时间窗: 7 day,1 month,3 month,6 month

Recurrence rates.

时间窗: 7 day,1 month,3 month,6 month

Post operative hospital stay

时间窗: 7 day,1 month,3 month,6 month

次要结局

  • Post operative complication.(Recurrence rate.)

研究者

发起方
Department of General Surgery
申办方类型
Government medical college

研究点 (1)

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