NCT01513005已完成不适用
Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- unexpected admission rate
研究概览
简要总结
The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.
详细描述
The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.
The sequence of this study is the following:
- patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
- medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
- during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
- after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
- the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
- the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
- follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sufficient understanding
- •good observance of medical prescription
- •availability of a responsible adult for the first operative night
- •patients living nearby the hospital (1 h maximum away)
- •telephonic accessibility
- •between 18 and 60 years old adults
- •body mass index less than 60 kg/m2
- •obesity requiring bariatric surgery
- •surgery validated by an obesity-related staff
排除标准
- •patient under administrative or legal protection
- •obesity without HAS criteria
- •cardiovascular comorbidity
- •pulmonary comorbidity
- •curative anticoagulant therapy
- •bad diabetes control
- •body mass index higher than 60 kg/m2
结局指标
主要结局
unexpected admission rate
时间窗: the day following the surgery
the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.
次要结局
- readmission rate(one year)
- overall length of stay(one year)
- per operative outcomes(one year)
- unexpected consultation rate(one year)
- reoperation rate(one year)
- postoperative outcomes(one year)
- efficiency of Laparoscopic Sleeve Gastrectomy(six months)
研究者
研究点 (2)
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