Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery (GASTRAMBU)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Obesity

Treatments: Procedure: Laparoscopic Sleeve Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01513005

PI10-PR.-REGIMBEAU

2010-A01178-31 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Laparoscopic Sleeve Gastrectomy

Experimental group

Treatment:

Procedure: Laparoscopic Sleeve Gastrectomy