Back to resultsComparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
laparoscopic Nissen/laparoscopic Thal
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring laparoscopy, fundoplication, Nissen, Thal, children, operative treatment of gastro-oesophageal reflux disease in children
Eligibility Criteria
Inclusion Criteria:
- Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)
Exclusion Criteria:
- Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
Sites / Locations
- Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust
Outcomes
Primary Outcome Measures
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 Outcome Measures
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)
Full Information
NCT ID
NCT01027975
First Posted
December 7, 2009
Last Updated
December 10, 2009
Sponsor
Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01027975
Brief Title
Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
Official Title
Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Oxford University Hospitals NHS Trust
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
laparoscopy, fundoplication, Nissen, Thal, children, operative treatment of gastro-oesophageal reflux disease in children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
laparoscopic Nissen/laparoscopic Thal
Primary Outcome Measure Information:
Title
Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
Title
Early death following surgery directly related to the fundoplication technique
Secondary Outcome Measure Information:
Title
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"
Title
Post-operative complications (e.g. post-operative dysphagia)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)
Exclusion Criteria:
Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh W Grant, MD
Organizational Affiliation
John Radcliffe Hospital, Department of Paediatric Surgery, Oxford,United Kingdom
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rainer Kubiak, MD
Organizational Affiliation
John Radcliffe Hospital, Department of Paediatric Surgery, Oxford, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust
City
Oxford (Headington)
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21233605
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
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