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临床试验/NCT01709877
NCT01709877Unknown不适用

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

Azienda Ospedaliero, Universitaria Pisana5 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年4月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Franco Mosca

Prof.

Azienda Ospedaliero, Universitaria Pisana

研究点 (5)

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