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临床试验/NCT01740973
NCT01740973已完成不适用

Risk of Umbilical Trocar-site Hernia After SILC Versus Conventional Laparoscopic Cholecystectomy

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 699 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
699
试验地点
1
主要终点
Umbilical trocar-site hernia formation

研究概览

简要总结

Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain, especially around the umbilical port is dominating the first postoperative week. Single Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative incisional pain and improve cosmetic results, but results are not convincing and the risk of formation of an umbilical trocar-site hernia is not properly investigated.

This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC vs. conventional 4-port laparoscopic cholesystectomy.

Methods This is a cohort registry study with prospective questionnaire and clinical follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a conventional laparoscopic cholecystectomy (consecutively from one month before and after SILC. They are matched for age, gender, date of operation, and surgeons skills (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation (operation for a umbilical hernia or clinical hernia).

The H0 hypothesis is that there is not difference between SILC and conventional.

Exclusion criteria are: death, operation for acute cholecystitis. The included patients will be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia, and perioperative data that we do not have in the database. Futhermore those patients who suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or discomfort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • SILC 1/1-2009-1/6-2011 and matched controls consecutively from the cholecystectomy-database having a lap. chol. one month before and one month after the SILC group.

排除标准

  • death in the follow-up time
  • an abdominal operation before la.chol/SILC with midline incision
  • an abdominal operation after la.chol/SILC with midline incision
  • primary operation for acute cholecystitis

结局指标

主要结局

Umbilical trocar-site hernia formation

时间窗: participants will be followed for expected average of 3 years

Operation for an umbilical trocar-site hernia or clinical trocar-site hernia formation

次要结局

  • chronic pain and discomfort(participants will be followed for expected average of 3 years)

研究者

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

Mette Willaume Christoffersen

M. D.

Hvidovre University Hospital

研究点 (1)

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