Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027975
• Other study ID #: RKubiak
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: December 10, 2009
• Start date: July 1998

Study information

• Verified date: February 2007
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 21 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• laparoscopic Nissen/laparoscopic Thal

Locations

Country	Name	City	State
United Kingdom	Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust	Oxford (Headington)	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)			No
Primary	Early death following surgery directly related to the fundoplication technique			No
Secondary	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"			No
Secondary	Post-operative complications (e.g. post-operative dysphagia)			No