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临床试验/NCT02738710
NCT02738710已完成不适用

Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision

Thammasat University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy

详细描述

Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •elective laparoscopic cholecystectomy
  • •willing to participate

排除标准

  • •pregnancy
  • •immunocompromised host
  • •on continuous ambulatory peritoneal dialysis
  • •morbid obesity (Body mass index > 35 kg/m2)
  • •End-stage renal disease with hemodialysis dependent
  • •uncontrolled coagulopathy

研究组 & 干预措施

transumbilical wound

Experimental

transumbilical incision

干预措施: transumbilical incision (Procedure)

infra umbilical wound

Active Comparator

infra umbilical incision

干预措施: Infra umbilical incision (Procedure)

结局指标

主要结局

Postoperative pain

时间窗: 7 days postoperatively

visual analog scale (0-10)

次要结局

  • wound infection(at 1 week and 1 month postoperatively)
  • patient satisfaction(1 week and 3 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boonying Siribumrungwong

Dr.

Thammasat University

研究点 (1)

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