Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Cosmetic Score
研究概览
简要总结
Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery.
The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency.
Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints.
This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients above 18 years of age for elective cholecystectomy
- •Written informed consent from the subject
- •INR < 1.4, platelet count > 50'000/mcl
排除标准
- •Women in pregnancy
- •Contraindications on ethical grounds
- •Severe coagulopathy (platelet < 50'000/mcl, double medication on platelet antagonists (Plavix and Aspirin), INR > 1.4
- •liver cirrhosis
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Cosmetic Score
时间窗: 6 weeks postoperatively
validated score where the minimum is 3 and the maximum 24 points. A higher score signifies a greater satisfaction of the physical appearance of the scar
次要结局
- Body Image(6 weeks postoperatively)
- Pain(up to 6 weeks postoperatively)