Clinical Outcomes of Absorbable or Hem-o-lok Clip Closure of the Cystic Stump in Laparoscopic Cholecystectomy: a Prospective Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.
研究概览
简要总结
Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.
详细描述
In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study
排除标准
- •open surgery emergency cholecystectomy refuse to trial
研究组 & 干预措施
Single absorbable
Cystic duct to be closed with absorbable single clip
干预措施: Surgycal procedure (Other)
Single Hem-o-lok
Cystic duct to be closed with Hem-o-lok single clip
干预措施: Surgycal procedure (Other)
结局指标
主要结局
Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.
时间窗: first 30 day
Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?
次要结局
- The costs of the clips used(one week)
研究者
Ulas Aday
Ass. Prof.
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital