Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

NCT ID: NCT00337402

Last Updated: 2006-11-22

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

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-06-30

Brief Summary

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Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Detailed Description

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Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy

Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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Gastrostomy Quality of life

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients \> 18 years-old
* ALS certain or probable
* vital capacity (respiratory) \> 70 %
* under riluzole

Exclusion Criteria

* ALS in family
* other conditions affected survival and QoL
* cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role collaborator

Neurological department of Lyon University Hospital

UNKNOWN

Sponsor Role collaborator

University Hospital, Marseille

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

University Hospital, Paris

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Principal Investigators

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Pierre Clavelou

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU63-0001

Identifier Type: -

Identifier Source: org_study_id