Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery

NCT ID: NCT01513005

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Sleeve Gastrectomy

Group Type EXPERIMENTAL

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

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

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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

CHU Amiens

Locations

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North Universitary 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)

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.

Reference Type RESULT
PMID: 27687352 (View on PubMed)

Other Identifiers

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2010-A01178-31

Identifier Type: OTHER

Identifier Source: secondary_id

PI10-PR.-REGIMBEAU

Identifier Type: -

Identifier Source: org_study_id

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