SLEEVERAS: Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT02042365

Collaborator

Direction Générale de l'Offre de Soins (Other), Ministry of Health, France (Other)

150

Enrollment

Location

Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the study is to test the feasibility of a protocol of enhanced recovery after surgery for reducing the total length of hospital stay in a large scale setting

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: ERAS (Enhanced recovery after surgery)

Detailed Description

This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Official Title:

Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
ERAS (Enhanced recovery after surgery) This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac	Procedure: ERAS (Enhanced recovery after surgery)

Arm

Intervention/Treatment

ERAS (Enhanced recovery after surgery)

This observational study evaluates the feasibility of ERAS pathway in six French departments of surgery located at Clermont-Ferrand, Bordeaux, Montpellier, Amiens, Strasbourg and Aurillac

Procedure: ERAS (Enhanced recovery after surgery)

Outcome Measures

Primary Outcome Measures

Duration of hospital stay [at day 1]
Posoperative day when the patients satisfies the criteria of discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Obese patients undergoing a sleeve gastrectomy Patients having signed the informed consent Patients over 18 year old ASA 1-3 Obesity with indication for surgery according the guidelines of the French High Authority for Health BMI < 50 kg/m2 No contra-indication for general anesthésia

Exclusion Criteria:

contra-indication for general anesthésia Age under 18 years ASA 4 BMI > 50 kg/m2 Patients having other serious comorbidities: cardiac, pulmonary, diabete, immunodepression, coagulopathy ou anticoagulant therapy Pregnancy Patients living alone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand
Direction Générale de l'Offre de Soins
Ministry of Health, France

Investigators

Principal Investigator: Karem SLIM, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT02042365

Other Study ID Numbers:

CHU-0178

First Posted:

Jan 22, 2014

Last Update Posted:

Feb 10, 2014

Last Verified:

Feb 1, 2014

Keywords provided by University Hospital, Clermont-Ferrand

Enhanced recovery,

sleeve gastrectomy,

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Feb 10, 2014