Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
NCT ID: NCT01551134
Last Updated: 2012-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
88 participants
INTERVENTIONAL
2003-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open fundoplication
Fundoplication performed with open surgery
Fundoplication
Primary fundoplication
Lap fundoplication
Primary fundoplication performed by laparoscopic surgery
Fundoplication
Primary fundoplication
Interventions
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Fundoplication
Primary fundoplication
Fundoplication
Primary fundoplication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients accepted for primary fundoplication at Oslo University Hospital
Exclusion Criteria
* 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)
15 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kristin Bjornland, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
Locations
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Oslo University Hospital
Oslo, Oslo County, Norway
Countries
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References
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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.
Kvello 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.
Other Identifiers
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S-03082
Identifier Type: -
Identifier Source: org_study_id
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