Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery (GASTRAMBU)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study|
- unexpected admission rate [ Time Frame: the day following the surgery ] [ Designated as safety issue: Yes ]the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.
- readmission rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]the readmission rate is defined as the number of readmission with conventional hospitalization
- unexpected consultation rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- overall length of stay [ Time Frame: one year ] [ Designated as safety issue: Yes ]the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up.
- per operative outcomes [ Time Frame: one year ] [ Designated as safety issue: Yes ]the per operative outcomes include each event observed during the surgical procedure
- postoperative outcomes [ Time Frame: one year ] [ Designated as safety issue: Yes ]the postoperative outcomes include all outcomes reported during the follow-up period
- efficiency of Laparoscopic Sleeve Gastrectomy [ Time Frame: six months ] [ Designated as safety issue: No ]the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire
|Study Start Date:||May 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: Laparoscopic Sleeve Gastrectomy||
Procedure: Laparoscopic Sleeve Gastrectomy
the operative technique consists in few steps:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513005
|North Universitary Hospital|
|Amiens, France, 80054|
|Principal Investigator:||Jean-Marc REGIMBEAU, MD,phD||CHU Amiens|