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临床试验/NCT03402542
NCT03402542已完成不适用

Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Surgery duration

研究概览

简要总结

Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic vesicular stones. There is considerable controversy as to whether it should be practiced in outpatient surgery or as part of inpatient surgery, regarding to patient safety.

"Minor" surgical procedures, such as anal surgery or simple inguinal hernia interventions, were initially considered eligible for an outpatient procedure. Advances in surgical techniques, anesthesia and early rehabilitation have also made it possible to consider more "heavy" interventions, such as cholecystectomy.

The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in outpatient surgery, taking surgical criteria into account.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other)

排除标准

  • Pregnant women
  • Diabetic patients under insulin treatment
  • History of major abdominal surgery
  • Acute cholecystitis as per anatomo-pathological examination

结局指标

主要结局

Surgery duration

时间窗: Up to 4h

Duration of the surgical intervention

Post surgical pain

时间窗: Up to 1 day after surgery

Pain killer medication administered post surgery, expressed in mg

Post surgery hospitalization duration

时间窗: Up to 10 days after surgery

Post surgery hospitalization duration

Medical complications after surgery

时间窗: Up to 1 year after surgery

Medical complications after surgery

Nausea

时间窗: Up to 1 day after surgery

Occurence of nausea or vomiting post surgery

次要结局

  • Body mass index(5 min)
  • Type of surgery(Up to 4 hours)
  • Data extraction from medical files: medical history(5 min)
  • Physical status score(5 min)
  • Hospitalisation type(Up to 10 days after surgery)

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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