A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post-operative pain 6 months
研究概览
简要总结
This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.
详细描述
As above
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of symptomatic gallstones
- •American Society of Anesthesiologists (ASA) score 1 or 2
- •informed consent
排除标准
- •active acute cholecystitis
- •previous open upper abdominal surgery
- •bleeding disorders
研究组 & 干预措施
SILC
Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision
干预措施: SILC (Procedure)
LC
Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank
干预措施: LC (Procedure)
结局指标
主要结局
Post-operative pain 6 months
时间窗: 6 months post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 24 hours
时间窗: 24 hours post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 4 hours
时间窗: 4 hours post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Post-operative pain 14 days
时间窗: 14 days post-operative
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
次要结局
- Procedural complications(6 months)
- Operative duration(following skin closure)
- Subject satisfaction(14 days and 6 months)
- Return to function(14 days)