跳至主要内容
临床试验/CTRI/2017/10/009976
CTRI/2017/10/009976已完成不适用

Comparison of unidirectional and bidirectional barbed suture in vaginal cuff closure during total laparoscopic hysterectomy- A randomized controlled trial

Jawaharlal Institute of Postgraduate Medical Education And Research JIPMER1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
To compare vault closure time during total laparoscopic hysterectomy (TLH) using unidirectional barbed suture with bidirectional barbed suture

研究概览

简要总结

Total laparoscopic hysterectomy (TLH) is a well established alternative to transabdominal hysterectomy for treatment of benign uterine disease with special advantage of less pain, shorter hospitalisation, earlier return to normal activities and better cosmetic outcome. In TLH when vaginal vault is closed laparoscopically intra corporeal knot tying is done which requires experience. With development in technology , several solutions have been proposed to reduce stress on surgeons. One of these is Barb technology, which has microscopic etching which allows self anchoring without the need of knots

In this study the time taken for closure of vaginal cuff in TLH using unidirectional and bidirectional barbed suture will be compared.

Hypothesis: Unidirectional barbed suture have to be locked by a loop at one end , this step is not needed for bidirectional barbed suture. Hence time taken for bidirectional barbed suture closure of vaginal cuff may be shorter

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • •Patients who are scheduled to undergo total laparoscopic hysterectomy for benign conditions.

排除标准

  • •Uterus >20 Weeks Acute PID.

结局指标

主要结局

To compare vault closure time during total laparoscopic hysterectomy (TLH) using unidirectional barbed suture with bidirectional barbed suture

时间窗: Duration in minutes

次要结局

  • To compare the post operative vaginal bleeding, infection and cuff dehiscence between the unidirectional and bidirectional barbed suture in total laparoscopic hysterectomy(2 and 4 weeks after the procedure)

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education And Research JIPMER
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验