Gastroesophageal Reflux DiseaseNCT01027975
Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
A study testing laparoscopic Nissen/laparoscopic Thal in people with Gastroesophageal Reflux Disease, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- laparoscopic Nissen/laparoscopic Thal
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 1998to not given
- 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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)
Who cannot join
- Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust
Oxford (Headington), Oxford, OX3 9DU
About this study
Official title: Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children
Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain.
The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- laparoscopic Nissen/laparoscopic Thal
- Keywords
- laparoscopy, fundoplication, Nissen, Thal, children, operative treatment of gastro-oesophageal reflux disease in children
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic Nissen/laparoscopic ThalProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
Early death following surgery directly related to the fundoplication technique
Secondary outcomes (2)
The resumption of symptoms bad enough to necessitate the re-introduction of anti-reflux medication (but not sufficiently bad to require revisional surgery) i.e. "intention to treat"
Post-operative complications (e.g. post-operative dysphagia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJul 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Hugh W Grant, MD, Study director, John Radcliffe Hospital, Department of Paediatric Surgery, Oxford,United KingdomRainer Kubiak, MD, Principal investigator, John Radcliffe Hospital, Department of Paediatric Surgery, Oxford, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027975
- Sponsor's protocol ID
- RKubiak
- Status last verified
- Feb 2007
- First submitted
- 7 Dec 2009
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Kubiak R, Andrews J, Grant HW. Long-term outcome of laparoscopic nissen fundoplication compared with laparoscopic thal fundoplication in children: a prospective, randomized study. Ann Surg. 2011 Jan;253(1):44-9. doi: 10.1097/SLA.0b013e3181fc98a0.
PubMed 21233605
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children
- ClinicalTrials.gov ID
- NCT01027975
- Acronym / sponsor ID
- RKubiak
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- laparoscopy, fundoplication, Nissen, Thal, children, operative treatment of gastro-oesophageal reflux disease in children
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jul 1998
- First posted
- 9 Dec 2009 (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.
Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain.
The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)
Key exclusion criteria (1 listed)
- Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
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 |
|---|---|---|
| laparoscopic Nissen/laparoscopic Thal | Procedure or surgery | – |
Primary outcome
Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
Early death following surgery directly related to the fundoplication technique
2 secondary outcomes
The resumption of symptoms bad enough to necessitate the re-introduction of anti-reflux medication (but not sufficiently bad to require revisional surgery) i.e. "intention to treat"
Post-operative complications (e.g. post-operative dysphagia)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Derived from this study: PubMed 21233605Kubiak R, Andrews J, Grant HW. Long-term outcome of laparoscopic nissen fundoplication compared with laparoscopic thal fundoplication in children: a prospective, randomized study. Ann Surg. 2011 Jan;253(1):44-9. doi: 10.1097/SLA.0b013e3181fc98a0.
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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.
Hugh W Grant, MD study director
John Radcliffe Hospital, Department of Paediatric Surgery, Oxford,United Kingdom
Rainer Kubiak, MD principal investigator
John Radcliffe Hospital, Department of Paediatric Surgery, Oxford, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic Nissen/laparoscopic Thal in people with Gastroesophageal Reflux Disease, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2009. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery). The study lists 2 primary outcomes in all. 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 NCT01027975, which also lists 1 linked publication.
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 11 Dec 2009.