Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHC22029
Study information
Scientific title
Acronym
Study hypothesis
To measure the effectiveness of fundoplication compared to medical managements in a randomised study of children with severe gastro-oesophageal reflux and thus develop management strategies for the appropriate and cost-effective treatment of children with gastro-oesophageal reflux.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Digestive system diseases: Other digestive system disease
Intervention
Fundoplication vs medical management
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Body weight Z scores.
Secondary outcome measures
1. Continuing or recurrent gastro-oesophageal reflux
2. Complication rate after fundoplication, ECA on EGG
3. Validated quality of life score for patients and parents
Overall trial start date
01/10/2000
Overall trial end date
01/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged less than 16 years with clinical evidence of gastro-oesophageal reflux. Phase One - 250 to 330. Phase Two - 115 to 125.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
455
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2000
Recruitment end date
01/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive North West (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary