GASTRAMBU: Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
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medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
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during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
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after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
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the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
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the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
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follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Laparoscopic Sleeve Gastrectomy
|
Procedure: Laparoscopic 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- readmission rate [one year]
the readmission rate is defined as the number of readmission with conventional hospitalization
- 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.
- per operative outcomes [one year]
the per operative outcomes include each event observed during the surgical procedure
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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sufficient understanding
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good observance of medical prescription
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availability of a responsible adult for the first operative night
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patients living nearby the hospital (1 h maximum away)
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telephonic accessibility
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between 18 and 60 years old adults
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body mass index less than 60 kg/m2
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obesity requiring bariatric surgery
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surgery validated by an obesity-related staff
Exclusion Criteria:
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patient under administrative or legal protection
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obesity without HAS criteria
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cardiovascular comorbidity
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pulmonary comorbidity
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curative anticoagulant therapy
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bad diabetes control
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body mass index higher than 60 kg/m2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Universitary Hospital | Amiens | France | 80054 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire, Amiens
Investigators
- Principal Investigator: Jean-Marc REGIMBEAU, MD,phD, CHU Amiens
Study Documents (Full-Text)
None provided.More Information
Publications
- Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016.
- Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.
- Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.
- Péquignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.
- Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.
- PI10-PR.-REGIMBEAU
- 2010-A01178-31