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临床试验/NCT00904865
NCT00904865Unknown2 期

Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
2 期
入组人数
200
试验地点
2
主要终点
Cosmesis, body image and quality of life scale

研究概览

简要总结

Background:

Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.

Objective:

Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.

Hypothesis:

SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.

Methods:

All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.

Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.

Randomization will be performed before surgeries after patients have given their informed consent to the study.

No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.

Endpoints:

  • Morbidity
  • Body image and Cosmetic results
  • Post-operative pain (opioid sparing effect)
  • Operative time
  • Hospital stay

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
None

入排标准

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

入选标准

  • Age more than 18 years

排除标准

  • Contraindication to laparoscopy
  • Liver disease
  • Cognitive trouble

结局指标

主要结局

Cosmesis, body image and quality of life scale

时间窗: at 1 month

次要结局

  • Post-operative pain(10 days)
  • Post-operative morbidity(at 30 days)
  • Operative time(day 1)

研究者

申办方类型
Other

研究点 (2)

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