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临床试验/NCT04423575
NCT04423575已完成不适用

Clinical and Economic Evaluation of Outpatient Bariatric Surgery

IHU Strasbourg1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月9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
60
试验地点
1
主要终点
Mean cost evaluation of health care pathway

研究概览

简要总结

This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient). Then, the study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences.

详细描述

This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient).

This single-center, matched case-control study will be conducted in the Endocrine and Digestive Surgery Unit, Center of Excellence in Bariatric Surgery, of the University Hospital of Strasbourg. All the patients scheduled for bariatric procedures (Roux-en-Y gastric bypass and Sleeve Gastrectomy) and eligible for outpatient ambulatory procedures, will be checked for the inclusion criteria and will be asked if they accepted the outpatient bariatric procedure. If they accept, they will be included in the group A ("Outpatients"). At the end of the inclusion period, the patients in group A will be paired to patients who were operated in the same period, who had a conventional hospitalization and who will be matched based on the type of intervention, the age and the ASA status. These patients will form the group B ("Inpatients").

The integrated care pathway of the outpatients was formalized in order to secure this care pathway. It includes: patient education, enhanced rehabilitation program, first-position surgical planning, follow-up by home nurse twice-a-day, standardized communication to surgeons, and management of possible complications. All the health care interventions (anticipated or not) will be recorded for both groups.

The study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences. A cost-minimization analysis will be performed from the perspective of the healthcare provider. The direct costs of care production will be considered and estimated by a micro-costing methodology. The time horizon is set from the pre-operative outpatient appointment with the bariatric surgeon to the one-month post-operative appointment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Patient between the age of 18 and 60
  • Patient with a BMI of more than 35 with comorbidities or BMI of more than 40
  • Speaking and understanding French
  • Access to a phone
  • Access to a suitable healthcare facility near his residence
  • Appropriate post-operative residence
  • Moderate and/or controlled comorbidities
  • Patient able to understand research objectives and risks and to give informed consent
  • Patient not living alone
  • affiliated to the French health insurance system

排除标准

  • patient unable to provide informed consent
  • Previous bariatric surgery
  • Previous laparotomy
  • BMI of more than 50
  • Insulin-dependent diabetes
  • Uncorrected preoperative anaemia
  • Anticoagulation that cannot be interrupted
  • Ischemic heart disease
  • Untreated obstructive sleep apnea syndrome (OSA)
  • Liver cirrhosis
  • Subject under guardianship, curatorship, safeguarding/protection of justice
  • Pregnancy
  • Breastfeeding

结局指标

主要结局

Mean cost evaluation of health care pathway

时间窗: from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment

Mean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology

次要结局

  • Readmission rate(from surgery to one month postoperatively)
  • Complication rate(from surgery to one month postoperatively)
  • Mean hospital length of stay(from surgery to one month postoperatively)
  • Costs related to Complication(from surgery to one month postoperatively)
  • Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale(at day 0, day 7 and day 30 postoperatively)
  • Ambulatory failure rate(from surgery to one month postoperatively)

研究者

发起方
IHU Strasbourg
申办方类型
Other
责任方
Sponsor

研究点 (1)

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