Outpatient Bariatric Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical and Economic Evaluation of Outpatient Bariatric Surgery

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Other: Outpatient health care pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) dialysis Liver cirrhosis Subject under guardianship, curatorship, safeguarding/protection of justice Pregnancy Breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatients<br>Health care pathway: patient education, communication to liberal nurses, first-position surgical planning, bariatric surgery (bypass or sleeve) as outpatient procedure, follow-up by home nurse twice-a-day, standardized communication to surgeons, management of possible complications | Other: Outpatient health care pathway<br>* A surgical procedure performed as an outpatient procedure means that the patient leaves the hospital before 8pm the same day. The surgery is identical but the standard care pathway is reinforced to insure a safe return to home.<br>|
| No Intervention: Inpatients<br>Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cost evaluation of health care pathway | Mean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology | from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean hospital length of stay | Mean hospital length of stay including readmission duration | from surgery to one month postoperatively | 
| Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale | The EQ-5D Quality of Life scale consists of : (i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. (ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state and Worst imaginable health state. | at day 0, day 7 and day 30 postoperatively | 
| Complication rate | rate of postoperative complications | from surgery to one month postoperatively | 
| Ambulatory failure rate | rate of patients in Arm 1 who spent at least the first night in the hospital | from surgery to one month postoperatively | 
| Readmission rate | rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0 | from surgery to one month postoperatively | 
| Costs related to Complication | costs related to the postoperative complications will be assessed by micro-costing methodology | from surgery to one month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Obesity, Outpatient Surgery, Bariatric Surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy