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

December 7, 2015 updated by: L. Michael Brunt

Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Achalasia

Exclusion Criteria:

  • Prior heller myotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic Dor fundoplication
Heller myotomy followed by Dor fundoplication
Procedure: Dor fundoplication
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
Active Comparator: Laparoscopic Toupet fundoplication
Heller myotomy followed by Toupet fundoplication
Procedure: Toupet fundoplication
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary outcomes are 24 hour pH testing results
Time Frame: pH testing at 6-12 months after surgical treatment
pH testing at 6-12 months after surgical treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs
Time Frame: 6-12 months after surgical intervention
6-12 months after surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L. Michael Brunt

Collaborators

University of Oregon
Northwestern University
Duke University
University of Washington

Investigators

  • Principal Investigator: L. Michael Brunt, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-0241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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