Comparative Effectiveness and safety of Hem-o-Lok® clips versus Endo loops for Appendicular stump closure in Laparoscopic Appendectomy: A randomized controlled trial in a Tertiary Care Center in Eastern Uttar Pradesh.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The time required to close the appendicular stump and investigate the differences in post-operative complications, including surgical site infections and stump leaks, as well as the length of hospital stay and recovery times between the two closure techniques.
研究概览
简要总结
During laparoscopic appendectomy, the appendiceal stump can be ligated and resected using various methods such as an endoloop, endostapler, or polymeric clip. While an endoloop may pose some challenges in handling, a polymeric clip offers the advantage of easy application. The safety of polymeric clips in this procedure is well-established,with several studies noting shorter surgical times compared to endoloops. Recent guidelines also endorse the use of polymeric clips due to their cost effectiveness and efficiency**. Furthermore, study showed fewer overall complications than using endoloops . However, there is a lack of sufficient evidence based data on this topic. This study aims to compare the effectiveness and safety of the widely available polymer locking ligation system that is Hem o Lok® clip versus the endoloop technique for stump closure in laparoscopic appendectomy.**
Hypothesis Hem o Lok® Clips are effective and safer than Endo Loops for Appendicular Stump Closure in Laparoscopic Appendectomy.
Patients will be randomized into one of the two study groups based on there order of arrival in opd all odd number patient will be group A hem o lok clip and all even number patient will be group B endoloop.
Patient will be followed for 40 days .in this duration patient will be assessed on day of discharge ,on the day when patient revisit for suture removal ,and 40 day after surgery .In addition patient will be assessed in between if any complications arise and patient revisit opd .
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.acute appendicitiS 2.chronic appendicitis.
排除标准
- •1.perforated appendicitis 2.necrotizing appendicitis 3.pregnant females 4.laparoscopic converted to open appendectomy 5.concomitant another procedure 6.patient not willing to be part of study.
结局指标
主要结局
The time required to close the appendicular stump and investigate the differences in post-operative complications, including surgical site infections and stump leaks, as well as the length of hospital stay and recovery times between the two closure techniques.
时间窗: Operative time and postoperative day 40.
次要结局
未报告次要终点
研究者
Dr Darshan Jalwal
All India Institute of Medical Sciences,Gorakhpur