Back to resultsIs Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
Primary Purpose
Gastroesophageal Reflux
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Fundoplication
Fundoplication
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux, Fundoplication, Randomized Controlled Trial, General Surgery, Child, Laparoscopy
Eligibility Criteria
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)
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open fundoplication
Lap fundoplication
Arm Description
Fundoplication performed with open surgery
Primary fundoplication performed by laparoscopic surgery
Outcomes
Primary Outcome Measures
Recurrence of reflux
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
Secondary Outcome Measures
Postoperative complication rate
Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.
Inflammatory response
indicies of inflammatory response
Parental stress
Indicies of parental stress caused by GER pre- and postoperatively
Full Information
NCT ID
NCT01551134
First Posted
March 8, 2012
Last Updated
March 9, 2012
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT01551134
Brief Title
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
Official Title
IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Fewer patients than anticipated were referred
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Gastroesophageal Reflux, Fundoplication, Randomized Controlled Trial, General Surgery, Child, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open fundoplication
Arm Type
Active Comparator
Arm Description
Fundoplication performed with open surgery
Arm Title
Lap fundoplication
Arm Type
Experimental
Arm Description
Primary fundoplication performed by laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Fundoplication
Other Intervention Name(s)
Gastroesophageal reflux
Intervention Description
Primary fundoplication
Intervention Type
Procedure
Intervention Name(s)
Fundoplication
Other Intervention Name(s)
Gastroesophageal reflux
Intervention Description
Primary fundoplication
Primary Outcome Measure Information:
Title
Recurrence of reflux
Description
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
Time Frame
12, 24 and 48 months
Secondary Outcome Measure Information:
Title
Postoperative complication rate
Description
Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.
Time Frame
30 days
Title
Inflammatory response
Description
indicies of inflammatory response
Time Frame
The first 4 p.o days
Title
Parental stress
Description
Indicies of parental stress caused by GER pre- and postoperatively
Time Frame
12 and 24 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Bjornland, MD, PhD
Organizational Affiliation
Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
35915187
Citation
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.
Results Reference
derived
PubMed Identifier
31124989
Citation
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.
Results Reference
derived
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Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
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