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

Tracking Information

First Received Date ^ICMJE

June 21, 2007

Last Updated Date

April 29, 2011

Start Date ^ICMJE

March 2003

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary outcomes are 24 hour pH testing results [ Time Frame: pH testing at 6-12 months after surgical treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00490750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Esophageal Achalasia

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Laparoscopic Dor fundoplication
Heller myotomy followed by Dor fundoplication

Intervention: Procedure: Dor fundoplication
Active Comparator: Laparoscopic Toupet fundoplication
Heller myotomy followed by Toupet fundoplication

Intervention: Procedure: Toupet fundoplication

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of Achalasia

Exclusion Criteria:

Prior heller myotomy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00490750

Other Study ID Numbers ^ICMJE

03-0241

Has Data Monitoring Committee

Responsible Party

L. Michael Brunt, MD, Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

University of Washington
Northwestern University
University of Oregon
Duke University

Investigators ^ICMJE

Principal Investigator:

L. Michael Brunt, MD

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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