Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT00337402
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

Study Timeline

• Study Start: 2002-01
• Study Completion: 2005-06
• Status Verified: 2006-06
• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Last Update Submitted: 2006-11-20
• Last Update Posted: 2006-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France