NCT01027975

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
Last Updated

December 11, 2009

Status Verified

February 1, 2007

First QC Date

December 7, 2009

Last Update Submit

December 10, 2009

Conditions

Gastroesophageal Reflux Disease

Keywords

laparoscopyfundoplicationNissenThalchildrenoperative treatment of gastro-oesophageal reflux disease in children

Outcome Measures

Primary Outcomes (2)

  • 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)

Interventions

laparoscopic Nissen/laparoscopic ThalPROCEDURE

Eligibility Criteria

Age1 Month - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)

You may not qualify if:

  • Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust

Oxford (Headington), Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21233605DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hugh W Grant, MD

    John Radcliffe Hospital, Department of Paediatric Surgery, Oxford,United Kingdom

    STUDY DIRECTOR

  • Rainer Kubiak, MD

    John Radcliffe Hospital, Department of Paediatric Surgery, Oxford, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

July 1, 1998

Last Updated

December 11, 2009

Record last verified: 2007-02

Locations

GB(1)