Purpose

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.


Condition Intervention
Esophageal Achalasia
Procedure: Laparoscopic Heller myotomy with partial fundoplication

MedlinePlus related topics:   Esophagus Disorders  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

Further study details as provided by Washington University School of Medicine:

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

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

Estimated Enrollment:   200
Study Start Date:   March 2003
Estimated Study Completion Date:   March 2008

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%u2019s 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Diagnosis of Achalasia

Exclusion Criteria:

  • Prior heller myotomy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490750

Contacts
Contact: L. Michael Brunt, MD     3144547194     bruntm@wustl.edu    
Contact: Peggy M Frisella, RN     3143628371     frisellap@wustl.edu    

Locations
United States, Missouri
Washington University School of Medicine     Recruiting
      Saint Louis, Missouri, United States, 63110
      Contact: Peggy M Frisella, RN     314-362-8371     frisellap@wustl.edu    

Sponsors and Collaborators
Washington University School of Medicine
University of Washington
Northwestern University
University of Oregon
Duke University

Investigators
Principal Investigator:     L. Michael Brunt, MD     Washington University School of Medicine    
Contact: L. Michael Brunt, MD     3144547194     bruntm@wustl.edu    
Contact: Peggy M Frisella, RN     3143628371     frisellap@wustl.edu    
United States, Missouri
Washington University School of Medicine     Recruiting
      Saint Louis, Missouri, United States, 63110
      Contact: Peggy M Frisella, RN     314-362-8371     frisellap@wustl.edu    
Washington University School of Medicine
University of Washington
Northwestern University
University of Oregon
Duke University
Principal Investigator:     L. Michael Brunt, MD     Washington University School of Medicine    
  More Information

Study ID Numbers:   03-0241
First Received:   June 21, 2007
Last Updated:   June 21, 2007
ClinicalTrials.gov Identifier:   NCT00490750
Health Authority:   United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Heller Dor  
Heller Toupet  
Myotomy  

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Esophageal disorder
Gastrointestinal Diseases
Esophageal Achalasia
Esophageal Diseases
Cardiospasm
Achalasia

Additional relevant MeSH terms:
Digestive System Diseases
Esophageal Achalasia

Source: National Library of Medicine (NLM) July 03, 2008