Study Stopped
Fewer patients than anticipated were referred
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study
1 other identifier
interventional
88
1 country
1
Brief Summary
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedMarch 12, 2012
March 1, 2012
6.9 years
March 8, 2012
March 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of reflux
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
12, 24 and 48 months
Secondary Outcomes (3)
Postoperative complication rate
30 days
Inflammatory response
The first 4 p.o days
Parental stress
12 and 24 months
Study Arms (2)
Open fundoplication
ACTIVE COMPARATORFundoplication performed with open surgery
Lap fundoplication
EXPERIMENTALPrimary fundoplication performed by laparoscopic surgery
Interventions
Primary fundoplication
Eligibility Criteria
You may qualify if:
- Age 0-15 years
- All patients accepted for primary fundoplication at Oslo University Hospital
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Oslo County, 0424, Norway
Related Publications (2)
Fyhn TJ, Kvello M, Edwin B, Schistad O, Pripp AH, Emblem R, Knatten CK, Bjornland K. Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial. Surg Endosc. 2023 Jan;37(1):189-199. doi: 10.1007/s00464-022-09458-6. Epub 2022 Aug 1.
PMID: 35915187DERIVEDKvello M, Avitsland TL, Knatten CK, Fyhn TJ, Malt U, Emblem R, Bjornland K. Psychologic Distress and Anxiety in Mothers of Children With Gastroesophageal Reflux Undergoing Antireflux Surgery. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):818-823. doi: 10.1097/MPG.0000000000002286.
PMID: 31124989DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Bjornland, MD, PhD
Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 12, 2012
Study Start
January 1, 2003
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 12, 2012
Record last verified: 2012-03