Gastroesophageal RefluxNCT01551134
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
A study testing Fundoplication in people with Gastroesophageal Reflux, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2003to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-15 years
- All patients accepted for primary fundoplication at Oslo University Hospital
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Fundoplication
- Keywords
- Gastroesophageal Reflux, Fundoplication, Randomized Controlled Trial, General Surgery, Child, Laparoscopy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FundoplicationProcedure or surgery
Also called Gastroesophageal reflux
Primary fundoplication
FundoplicationProcedure or surgery
Also called Gastroesophageal reflux
Primary fundoplication
| Study group | Role | What they receive |
|---|---|---|
| Open fundoplication | Active comparator | Fundoplication performed with open surgery Receives: Procedure: Fundoplication |
| Lap fundoplication | Experimental | Primary fundoplication performed by laparoscopic surgery Receives: Procedure: Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of reflux
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
Measured: 12, 24 and 48 months
Secondary outcomes (3)
Postoperative complication rate
Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.
Measured: 30 days
Inflammatory response
indicies of inflammatory response
Measured: The first 4 p.o days
Parental stress
Indicies of parental stress caused by GER pre- and postoperatively
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2003
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Fewer patients than anticipated were referred
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Kristin Bjornland, MD, PhD, Principal investigator, Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551134
- Sponsor's protocol ID
- S-03082
- Status last verified
- Mar 2012
- First submitted
- 8 Mar 2012
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35915187Kvello 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.
PubMed 31124989
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study
- ClinicalTrials.gov ID
- NCT01551134
- Acronym / sponsor ID
- S-03082
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, Fundoplication, Randomized Controlled Trial, General Surgery, Child, Laparoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Fewer patients than anticipated were referred
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open fundoplication | Active comparator | Procedure: FundoplicationFundoplication performed with open surgery |
| Lap fundoplication | Experimental | Procedure: FundoplicationPrimary fundoplication performed by laparoscopic surgery |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 0-15 years
- All patients accepted for primary fundoplication at Oslo University Hospital
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FundoplicationAlso: Gastroesophageal refluxPrimary fundoplication | Procedure or surgery | Open fundoplication |
| FundoplicationAlso: Gastroesophageal refluxPrimary fundoplication | Procedure or surgery | Lap fundoplication |
Primary outcome
Recurrence of reflux
Time frame: 12, 24 and 48 months
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
3 secondary outcomes
Postoperative complication rate
Time frame: 30 days
Inflammatory response
Time frame: The first 4 p.o days
Parental stress
Time frame: 12 and 24 months
Results and safety
The study was stopped early (reason given: Fewer patients than anticipated were referred). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
- Derived from this study: PubMed 35915187Fyhn 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.
- Derived from this study: PubMed 31124989Kvello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Bjornland, MD, PhD principal investigator
Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fundoplication in people with Gastroesophageal Reflux, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Fewer patients than anticipated were referred). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of reflux (time frame: 12, 24 and 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.