Obesity
Conditions
Keywords
Laparoscopic Sleeve Gastrectomy, obesity management
Brief summary
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
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: 1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests. 2. medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed. 3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study 4. after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit. 5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...) 6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up. 7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
Interventions
PROCEDURELaparoscopic Sleeve Gastrectomy
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
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| unexpected admission rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| unexpected consultation rate | one year | the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...) |
| reoperation rate | one year | — |
| overall length of stay | one year | the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up. |
| readmission rate | one year | the readmission rate is defined as the number of readmission with conventional hospitalization |
| postoperative outcomes | one year | the postoperative outcomes include all outcomes reported during the follow-up period |
| efficiency of Laparoscopic Sleeve Gastrectomy | six months | the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire |
| per operative outcomes | one year | the per operative outcomes include each event observed during the surgical procedure |
Countries
France
Outcome results
None listed