A Prospective, Single-blind, Randomized, Multi centre, study to assess the clinical equivalence of Trutie® Ligating clips to Ligaclip® ligating clips in laparoscopic cholecystectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Assess the incidence of bile leakage and bleeding after closure of cystic duct and cystic artery in both groups
研究概览
简要总结
The current study aims to establish clinical equivalence of Trutie® Ligating clips (Healthium Medtech Limited) to Ligaclip® ligating clips (Ethicon) in laparoscopic cholecystectomy and generate additional evidence on usage of Titanium metal ligating clips. The use of surgical clips is crucial in laparoscopic surgery/ cholecystectomy. Titanium ligating clips are a type of non-absorbable clip that are commonly used in laparoscopic cholecystectomy procedures to secure the cystic duct and cystic artery during gallbladder removal. These clips are made of a lightweight, durable metal and are designed to provide a secure and permanent closure of the ducts. In current study we plan to assess the clinical equivalence of both devices via incidence of bile leakage and bleeding after closure of cystic duct and cystic artery, assessment of intra and post-operative complications, adverse device reactions, and adverse events from day of surgery to 6 months post-operatively, time taken from initial incision to closure of wound, intraoperative handling of clips and clip applicator between the two groups using 5-point scale, number of clip breakage, failure to ligate, and malformed or deformed clips, Postoperative length of hospital stay, incidence of residual risks of ligating clips, time to recovery as measured by return to the normal day to day activities and quality of life using the Otago gallstones condition specific questionnaire. Clinical data obtained by this study will add value to the user’s decision to choose the titanium ligating clip in various surgeries.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female patients aged between 18 to 60 years
- •Subjects scheduled for elective laparoscopic cholecystectomy surgery
- •Subjects willing to give written informed consent and willing to comply with all study requirements.
排除标准
- •Subjects with history of pancreatitis
- •Subjects with suspicion of gallbladder carcinoma or other metastatic diseases
- •Subjects who are pregnant or lactating at the time of surgery
- •Subjects with coagulation disorder
- •Subjects intraoperatively found to have with modified Nassar difficulty grading scale 3 4 and 5
- •Subjects whose surgical approach got converted from laparoscopic to open surgery.
结局指标
主要结局
Assess the incidence of bile leakage and bleeding after closure of cystic duct and cystic artery in both groups
时间窗: Day of surgery, Day of discharge, Day 10 post surgery, Day 30 post surgery, Day 180 post surgery
次要结局
- To evaluate the quality of life using the Otago gallstones condition specific questionnaire(Baseline visit Day 30 post surgery Day 180 post surgery)
- Assessment of intra and post operative complications adverse device reactions and adverse events from day of surgery to 6 months post operatively(Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery)
- Number of clips used to ligate cystic duct and artery(Day of surgery)
- Time taken from initial incision to closure of wound
- Postoperative length of hospital stay in both the groups(Day of discharge)
- To assess the incidence of residual risks of ligating clips(Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery)
- Assessment of intraoperative handling of clips between the two groups using 5 point scale and Assessment of number of clip breakage failure to ligate and malformed or deformed clips(Day of surgery)
- To assess the time to recovery as measured by return to the normal day to day activities(Day 10 post surgery Day 30 post surgery Day 180 post surgery)