Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
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
- 否
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)
