Randomised controlled study of fundoplication or medical treatment for gastro-oesophageal reflux in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82683558

Enrollment

455

Registered

2004-01-23

Start date

2000-10-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Digestive system diseases: Other digestive system disease Digestive System Gastro-Oesophageal Reflux (GORD)

Interventions

Fundoplication vs medical management

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Body weight Z scores.	—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026