Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Keywords

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laparoscopy fundoplication Nissen Thal children operative treatment of gastro-oesophageal reflux disease in children

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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laparoscopic Nissen/laparoscopic Thal

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Department of Paediatric Surgery, John Radcliffe Hospital, Oxford, U.K.

Principal Investigators

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Hugh W Grant, MD

Role: STUDY_DIRECTOR

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

Rainer Kubiak, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust

Oxford (Headington), Oxford, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 21233605 (View on PubMed)

Other Identifiers

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RKubiak

Identifier Type: -

Identifier Source: org_study_id