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NCT02042365 Clinical Trial

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

Obesity Clinical Trial

— SLEEVERAS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02042365
Other study ID # CHU-0178
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 20, 2014
Last updated February 7, 2014
Start date February 2014
Est. completion date December 2014

Study information
Verified date February 2014
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• ERAS (Enhanced recovery after surgery)

Locations
Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand DGOS : Executive Office for Care Offer, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of hospital stay Posoperative day when the patients satisfies the criteria of discharge at day 1 Yes
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