- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551134
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
March 9, 2012 updated by: Oslo University Hospital
IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0424
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open fundoplication
Fundoplication performed with open surgery
|
Primary fundoplication
Other Names:
|
Experimental: Lap fundoplication
Primary fundoplication performed by laparoscopic surgery
|
Primary fundoplication
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of reflux
Time Frame: 12, 24 and 48 months
|
GER symptoms and GER on pH monitoring.
Need for redo fundoplication.
PPI.
|
12, 24 and 48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complication rate
Time Frame: 30 days
|
Perioperative complications.
Duration of surgery.
Postoperative complications.
Lenght of hospital stay.
Readmission to hospital.
|
30 days
|
Inflammatory response
Time Frame: The first 4 p.o days
|
indicies of inflammatory response
|
The first 4 p.o days
|
Parental stress
Time Frame: 12 and 24 months
|
Indicies of parental stress caused by GER pre- and postoperatively
|
12 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristin Bjornland, MD, PhD, Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 8, 2012
First Submitted That Met QC Criteria
March 9, 2012
First Posted (Estimate)
March 12, 2012
Study Record Updates
Last Update Posted (Estimate)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 9, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-03082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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