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

Primary Purpose

Obesity

Status

Unknown status

Phase

Locations

France

Study Type

Observational

Intervention

ERAS (Enhanced recovery after surgery)

About this trial

This is an observational trial for Obesity focused on measuring Enhanced recovery,, sleeve gastrectomy,

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Arm Label

ERAS (Enhanced recovery after surgery)

Arm 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

Outcomes

Primary Outcome Measures

Duration of hospital stay

Posoperative day when the patients satisfies the criteria of discharge

Secondary Outcome Measures

Full Information

NCT ID

NCT02042365

First Posted

January 20, 2014

Last Updated

February 7, 2014

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02042365

Brief Title

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

Acronym

SLEEVERAS

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

November 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

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

4. Oversight

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Enhanced recovery,, sleeve gastrectomy,

7. Study Design

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ERAS (Enhanced recovery after surgery)

Arm 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

Intervention Type

Procedure

Intervention Name(s)

ERAS (Enhanced recovery after surgery)

Primary Outcome Measure Information:

Title

Duration of hospital stay

Description

Posoperative day when the patients satisfies the criteria of discharge

Time Frame

at day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Population Description

obese patients undergoing a sleeve gastrectomy

Sampling Method

Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karem SLIM

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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