NCT01551134TerminatedNot Applicable
IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study
Oslo University Hospital2 sites in 1 country88 target enrollmentStarted: January 1, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Recurrence of reflux
Study Overview
Brief Summary
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 0-15 years
- •All patients accepted for primary fundoplication at Oslo University Hospital
Exclusion Criteria
- •Age over 16 years
- •Parents not speaking Norwegian or English well
- •Prior fundoplication
- •Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)
Outcomes
Primary Outcomes
Recurrence of reflux
Time Frame: 12, 24 and 48 months
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
Secondary Outcomes
- Postoperative complication rate(30 days)
- Inflammatory response(The first 4 p.o days)
- Parental stress(12 and 24 months)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Conventional Nissen Fundoplication Versus Laparoscopic Nissen FundoplicationGERDNCT01230944Turku University Hospital110
Completed
Not Applicable
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized TrialGastroesophageal Reflux DiseaseLaparoscopic Antireflux SurgeryNCT01321294General Public Hospital Zell am See
Completed
Not Applicable
Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3-Year Follow-up Study of Randomized Controlled Trial.Gastro -Oesophagal RefluxNCT00259961Institute of Child Health
Not yet recruiting
Not Applicable
A trial of two different operations to treat gastro-oesophageal reflux disease in obese patientsgastro-oesophageal reflux diseaseOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonDiet and Nutrition - ObesitySurgery - Surgical techniquesobesityACTRN12622000636752Princess Alexandra Hospital182
Completed
Not Applicable
ong-term Outcome of Laparoscopic Nissen and Laparoscopic Toupet Fundoplication for Gastro-Esophageal Reflux Disease: a prospective, randomized trial.Gastro-esophageal reflux diseaseOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonSurgery - Surgical techniquesACTRN12609000030279Groote Schuur Hospital100