Prospective Multicentre Study Assessing the Feasibility o... | NCT02042365

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

NCT02042365

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Feb 10, 2014Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Obesity

Interventions

ERAS (Enhanced recovery after surgery)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Nov 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jan 20, 2014

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2014

Last Update Posted Date

Feb 10, 2014Estimated

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

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERAS (Enhanced recovery after surgery)	Procedure		ERAS (Enhanced recovery after surgery)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of hospital stay	Posoperative day when the patients satisfies the criteria of discharge	at day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

obese patients undergoing a sleeve gastrectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Karem SLIM	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand		Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000080482	Enhanced Recovery After Surgery

Ancestor Terms

ID	Term
D019990	Perioperative Care
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided