Clinical trial NCT01513005: Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery
Official title: Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Laparoscopic Sleeve Gastrectomy
obesity management
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: unexpected admission rate
timeFrame: the day following the surgery
Secondary outcomes:
measure: readmission rate
timeFrame: one year
measure: unexpected consultation rate
timeFrame: one year
measure: reoperation rate
timeFrame: one year
measure: overall length of stay
timeFrame: one year
measure: per operative outcomes
timeFrame: one year
measure: postoperative outcomes
timeFrame: one year
measure: efficiency of Laparoscopic Sleeve Gastrectomy
timeFrame: six months
Other outcomes:
Locations:
city: Amiens
country: France
facility: North Universitary Hospital
Study officials:
affiliation: CHU Amiens
name: Jean-Marc REGIMBEAU, MD,phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pequignot 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.
citation: 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. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3.