Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00337402

Enrollment

380

Registered

2006-06-16

Start date

2002-01-31

Completion date

2005-06-30

Last updated

2006-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Gastrostomy, Quality of life

Brief summary

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

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

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

France

Outcome results