跳至主要内容
临床试验/NCT03070457
NCT03070457Unknown不适用

Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial

Hospital Universitari de Bellvitge2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Readmissions rate

研究概览

简要总结

Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.

详细描述

This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients eligible for Sleeve gastrectomy
  • BMI 35 to 50
  • ASA I to III
  • Conventional address close to our Hospital
  • Laparoscopic surgery
  • Accompanying person after discharge
  • Availability for a smart phone

排除标准

  • Revisional Surgery
  • Conversion to laparotomy
  • ICU Admission after surgery
  • Insulin dependent Diabetes Mellitus
  • Surgery finishing after 3 pm

结局指标

主要结局

Readmissions rate

时间窗: 1 month

No hospital admissions after surgery

次要结局

  • Chronogram for complications after surgery(1 month)
  • Quality of life(1 month)
  • Patients agreement to the protocol(1 month)
  • Morbidity rate(1 month)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amador Garci-a Ruiz de Gordejuela

MD, PhD

Hospital Universitari de Bellvitge

研究点 (2)

Loading locations...

相似试验