Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine University of Washington Northwestern University University of Oregon Duke University
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00490750

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

MedlinePlus related topics: Esophagus Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Bio-equivalence 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 ] [ 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:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Laparoscopic Dor fundoplication: Active Comparator Heller myotomy followed by Dor fundoplication	Procedure: Dor fundoplication Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
Laparoscopic Toupet fundoplication: Active Comparator 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

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

More Information

Responsible Party:	Chiarman, Surgery, Northwestern University Medical School ( Nathaniel Soper, MD )
Study ID Numbers:	03-0241
Study First Received:	June 21, 2007
Last Updated:	February 3, 2009
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
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Esophageal Achalasia
Esophageal Diseases
Cardiospasm
Achalasia

ClinicalTrials.gov processed this record on February 06, 2009