Clinical trial NCT01539967: Impact of the Residual Gastric Volume in Laparoscopic Sleeve Gastrectomy's Failure
Official title: Is the Residual Gastric Volume After Sleeve Gastrectomy an Objective Criterion to Adapt the Treatment Strategy After Failure?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Laparoscopic Sleeve Gastrectomy
Obesity follow-up
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. The surgical management of this illness consists in different techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the residual gastric volume.

The aim of the present study was to determine whether the residual gastric volume is involved in Laparoscopic Sleeve Gastrectomy's failure.

Detailed description: This study can be done in three steps:

1. From a prospective database, patients are selected if they were operated by Laparoscopic Sleeve gastrectomy at least two years before.
2. these patients are convoked by their surgeon, who proposed them to participate at this study. During this consultation, the BAROS score is calculated by the surgeon and reported in the case report form of the patient.
3. After checking the possible contraindication, a gastric computed tomography volumetry is done and the residual gastric volume is calculated by two independent radiologists.

Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* laparoscopic Sleeve gastrectomy performed two years before
* surgery performed in the digestive surgery department of the Amiens University Hospital

Exclusion Criteria:

* pregnancy or breastfeeding
* death of the patient or lost of follow-up
* patient under legal or administrative protection
* contraindication to the volumetry (pregnancy, technical impossibility)

Primary outcomes:
measure: calculation of the BAROS Score
timeFrame: during the consultation two years after the surgery
Secondary outcomes:
measure: measure of the residual gastric volume by the radiologists
timeFrame: two years after the surgical procedure
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
Study officials:
affiliation: Amiens Universitary Hospital
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.