Randomised Non-inferiority Trial of Laparoscopic Cholecystectomy Performed With EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach Using Clinical, PROMS and Health Economic Endpoints
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Conversion rate
研究概览
简要总结
Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic gallstone disease
- •Age between 18 and 80 years
排除标准
- •ASA III or more
- •significant co-morbid cardiovascular, neurological diseases, diabetics and chronic obstructive airway disease
- •patients with previous history of invasive cancer
- •patients with previous surgery
- •patients requiring urgent/emergency interventions
结局指标
主要结局
Conversion rate
时间窗: During the intervention
1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
Morbidity
时间窗: 30 days
1 = if the patient has surgical complications 0 = no complications
Mortality
时间窗: 30 days
次要结局
- Postoperative course(1 week)
- Duration of hospital stay(6 days)
- Return of bowel function(12, 24, 48 hours)
研究者
Franco Mosca
Prof.
Azienda Ospedaliero, Universitaria Pisana
