跳至主要内容
临床试验/NCT05208385
NCT05208385已完成不适用

Effectiveness of the Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy: Prospective Randomized Clinical Trial of 240 Patients

Samsun Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年1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
发起方
入组人数
240
试验地点
1
主要终点
Trocar site hernia (TSH)

研究概览

简要总结

A prospective randomized study was performed including consecutive patients who underwent an elective laparoscopic cholecystectomy (LC) for symptomatic cholelithiasis during the 18 months period. This prospective randomized trial aims to compare two umbilical closure techniques for trocar site hernia (TSH) in laparoscopic cholecystectomy.

详细描述

Laparoscopic cholecystectomy (LC) is currently the gold standard in the treatment for symptomatic cholelithiasis that offers a variety of advantages over conventional open surgery such as shorter recovery time, better cosmesis, less wound complication rates, and less pain (1,2). Despite these advantages, LC can result in unique complications. Among these complications, trocar site hernia (TSH) is one of the most important complications because laparoscopic cholecystectomy promises smaller abdominal incisions and better cosmetic outcomes. A second surgical intervention due to TSH may overshadow the gains of the previous laparoscopic surgery. In studies conducted to date, the rate of trocar hernia in laparoscopic cholecystectomy has been presented at very different rates. Many studies have shown that the most frequent site of TSH is the umbilical trocar site (3-6).

To avoid this important complication of laparoscopic cholecystectomy, many different techniques have been described to date for trocar port fascia repair (7-12). Most of these techniques require special devices. In addition, a few studies compare these techniques with standard fascial closure, which is mostly used by surgeons (11,12).

We hypothesized that the fascial closure of the umbilical trocar incision under the intra-abdominal vision with the laparoscopic camera could be reduced TSH. This prospective randomized controlled study aims to assess whether fascial closure of umbilical trocar site under direct laparoscopic vision in LC can reduce the incidence of TSH.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

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

  • •age above 18 years
  • •symptomatic cholelithiasis

排除标准

  • •acute cholecystitis
  • •age under 18 years
  • •previous umbilical hernia repair
  • •pre-existing umbilical hernia

研究组 & 干预措施

Standard umbilical trocar incision closure (UC)

Other

standard umbilical trocar incision closure

干预措施: video-assisted umbilical closure (Procedure)

Video-assisted umbilical trocar incision closure (UCVA))

Active Comparator

video-assisted umbilical trocar incision closure

干预措施: video-assisted umbilical closure (Procedure)

结局指标

主要结局

Trocar site hernia (TSH)

时间窗: 18 months

trocar site hernia presence

次要结局

  • Length of hospital stay (LOH)(18 months)
  • Wound infection (WI)(three weeks later)
  • Abdominal Pain(Preoperative first day, postoperative first day)
  • Hematoma (H)(18 months (postoperative first day and three weeks later))

研究者

发起方
Samsun Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Colak

Associate Professor

Samsun Education and Research Hospital

研究点 (1)

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