Impact of the Residual Gastric Volume in Laparoscopic Sleeve Gastrectomy's Failure

NCT ID: NCT01539967

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Marc REGIMBEAU, MD,phD

Role: PRINCIPAL_INVESTIGATOR

Amiens Universitary Hospital

Locations

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Amiens University Hospital

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 21769286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20971049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19902316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19081482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18696169 (View on PubMed)

Deguines JB, Verhaeghe P, Yzet T, Robert B, Cosse C, Regimbeau JM. Is the residual gastric volume after laparoscopic sleeve gastrectomy an objective criterion for adapting the treatment strategy after failure? Surg Obes Relat Dis. 2013 Sep-Oct;9(5):660-6. doi: 10.1016/j.soard.2012.11.010. Epub 2013 Jan 17.

Reference Type RESULT
PMID: 23452922 (View on PubMed)

Other Identifiers

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2009-A00603-54

Identifier Type: OTHER

Identifier Source: secondary_id

PI09-PR-REGIMBEAU

Identifier Type: -

Identifier Source: org_study_id

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