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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Washington
Northwestern University
University of Oregon
Duke University
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00490750
First received: June 21, 2007
Last updated: April 29, 2011
Last verified: April 2011
History of Changes
  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: Dor fundoplication
Procedure: Toupet fundoplication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs [ Time Frame: 6-12 months after surgical intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2003
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
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
  More Information

No publications provided

Responsible Party: L. Michael Brunt, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00490750     History of Changes
Other Study ID Numbers: 03-0241
Study First Received: June 21, 2007
Last Updated: April 29, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Diseases
Esophageal Motility Disorders
 Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013