An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 3
- 主要终点
- Health-related quality of life, postoperative pain, and health care costs.
研究概览
简要总结
The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.
详细描述
Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. However, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.
Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.
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
- •Cholecystectomy is considered the best available treatment.
- •The patient understands trial information and is capable of making a decision after having received information.
- •The patient wants to undergo cholecystectomy and accepts participation in the trial.
排除标准
- •Age below 18 years.
- •The patient is unable to understand trial information.
- •Competence for both trial groups are lacking when a patient is randomized.
- •The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
- •The indication of cholecystectomy is proven or suspected cancer of the gallbladder.
结局指标
主要结局
Health-related quality of life, postoperative pain, and health care costs.
时间窗: Three, seven, eleven, and 30 postoperative days and one year after the operation.
次要结局
- Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.(Thirty days and one year after the operation.)