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Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

NCT ID: NCT00490750

Last Updated: 2015-12-09

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

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2011-08-31

Brief Summary

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The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.

Detailed Description

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Idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. Although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. Several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. However, a main deterrent to long-term success is the development of gastroesophageal reflux disease (GERD) despite the use of an antireflux procedure. For this reason, most surgeons add a partial fundoplication to the myotomy. The gastric fundus can either be wrapped anterior to the esophagus (Dor fundoplication), or posterior to the esophagus (Toupet fundoplication). Currently, the type of fundoplication is determined by surgeon's choice. There exists no systematic comparison of the two procedures. This multicenter, randomized study aims to evaluate patient outcomes following myotomy and Dor versus Toupet fundoplication.

Conditions

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Esophageal Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laparoscopic Dor fundoplication

Heller myotomy followed by Dor fundoplication

Group Type ACTIVE_COMPARATOR

Dor fundoplication

Intervention Type PROCEDURE

Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication

Laparoscopic Toupet fundoplication

Heller myotomy followed by Toupet fundoplication

Group Type ACTIVE_COMPARATOR

Toupet fundoplication

Intervention Type PROCEDURE

Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication

Interventions

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Dor fundoplication

Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication

Intervention Type PROCEDURE

Toupet fundoplication

Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Achalasia

Exclusion Criteria

* Prior heller myotomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of Oregon

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

L. Michael Brunt

OTHER

Sponsor Role lead

Responsible Party

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L. Michael Brunt

Professor of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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L. Michael Brunt, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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03-0241

Identifier Type: -

Identifier Source: org_study_id