Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Sleeve Gastrectomy<br> | Procedure: Laparoscopic Sleeve Gastrectomy<br>* the operative technique consists in few steps: position of 4 trocars and insertion of a nasogastric tube dissection and mobilization of the greater curvature of the stomach preparation of the stomach for division gastric partition extraction of the gastric remnant postoperative surveillance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unexpected admission rate | the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery. | the day following the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| readmission rate | the readmission rate is defined as the number of readmission with conventional hospitalization | one year | 
| unexpected consultation rate | the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...) | one year | 
| reoperation rate |  | one year | 
| overall length of stay | the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up. | one year | 
| per operative outcomes | the per operative outcomes include each event observed during the surgical procedure | one year | 
| postoperative outcomes | the postoperative outcomes include all outcomes reported during the follow-up period | one year | 
| efficiency of Laparoscopic Sleeve Gastrectomy | the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Sleeve Gastrectomy, obesity management