Randomised controlled study of fundoplication or medical treatment for gastro-oesophageal reflux in children
| ISRCTN | ISRCTN82683558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82683558 |
| Protocol serial number | RHC22029 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive North West (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 16/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Lloyd
Scientific
Scientific
Royal Liverpool Children's Hospital NHS Trust
Professor of Paediatric Surgery
Institute of Child Health, Eaton Road
Eaton Road
Liverpool
L12 2AP
United Kingdom
| Phone | +44 (0)151 252 5250 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive system diseases: Other digestive system disease |
| Intervention | Fundoplication vs medical management |
| Intervention type | Other |
| Primary outcome measure(s) |
Body weight Z scores. |
| Key secondary outcome measure(s) |
1. Continuing or recurrent gastro-oesophageal reflux |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 455 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
