Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3-Year Follow-up Study of Randomized Controlled Trial.

Completed

• Conditions: Gastro -Oesophagal Reflux

• Registration Number: NCT00259961
• Lead Sponsor: Institute of Child Health

Brief Summary

Long-term results following laparoscopic and open Nissen fundoplication for gastro-oesophageal reflux will be objectively assessed in a selected population of patients already included in a randomized controlled trial comparing the two different techniques. The presence of postoperative symptoms will be evaluated by an independent clinician using an objective questionnaire. The recurrence of gastro-oesophageal reflux will be studied by 24-hours pH study. Furthermore the presence of gastric motility disorders will be studied by electrogastrography and 13C-octanoic acid breath test.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-30
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-01
• Status Verified: 2006-12
• Study Completion: 2006-12
• Last Update Submitted: 2006-12-22
• Last Update Posted: 2006-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients with gastro - oesophagal reflux -

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom