Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery (GASTRAMBU)
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|ClinicalTrials.gov Identifier: NCT01513005|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : February 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: Laparoscopic Sleeve Gastrectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2013|
|Experimental: Laparoscopic Sleeve Gastrectomy||
Procedure: Laparoscopic Sleeve Gastrectomy
the operative technique consists in few steps:
- unexpected admission rate [ Time Frame: 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.
- readmission rate [ Time Frame: one year ]the readmission rate is defined as the number of readmission with conventional hospitalization
- unexpected consultation rate [ Time Frame: 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 [ Time Frame: one year ]
- overall length of stay [ Time Frame: 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.
- per operative outcomes [ Time Frame: one year ]the per operative outcomes include each event observed during the surgical procedure
- postoperative outcomes [ Time Frame: one year ]the postoperative outcomes include all outcomes reported during the follow-up period
- efficiency of Laparoscopic Sleeve Gastrectomy [ Time Frame: six months ]the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513005
|North Universitary Hospital|
|Amiens, France, 80054|
|Principal Investigator:||Jean-Marc REGIMBEAU, MD,phD||CHU Amiens|