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

Primary Purpose

Esophageal Achalasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dor fundoplication

Toupet fundoplication

About this trial

This is an interventional treatment trial for Esophageal Achalasia focused on measuring Heller Dor, Heller Toupet, Myotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Diagnosis of Achalasia

Exclusion Criteria:

Prior heller myotomy

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Laparoscopic Dor fundoplication

Laparoscopic Toupet fundoplication

Arm Description

Heller myotomy followed by Dor fundoplication

Heller myotomy followed by Toupet fundoplication

Outcomes

Primary Outcome Measures

Primary outcomes are 24 hour pH testing results

Secondary Outcome Measures

Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs

Full Information

NCT ID

NCT00490750

First Posted

June 21, 2007

Last Updated

December 7, 2015

Sponsor

L. Michael Brunt

Collaborators

University of Washington, Northwestern University, University of Oregon, Duke University

1. Study Identification

Unique Protocol Identification Number

NCT00490750

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

L. Michael Brunt

Collaborators

University of Washington, Northwestern University, University of Oregon, Duke University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Achalasia

Keywords

Heller Dor, Heller Toupet, Myotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Dor fundoplication

Arm Type

Active Comparator

Arm Description

Heller myotomy followed by Dor fundoplication

Arm Title

Laparoscopic Toupet fundoplication

Arm Type

Active Comparator

Arm Description

Heller myotomy followed by Toupet fundoplication

Intervention Type

Procedure

Intervention Name(s)

Dor fundoplication

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Toupet fundoplication

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary outcomes are 24 hour pH testing results

Time Frame

pH testing at 6-12 months after surgical treatment

Secondary Outcome Measure Information:

Title

Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs

Time Frame

6-12 months after surgical intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Achalasia Exclusion Criteria: Prior heller myotomy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

L. Michael Brunt, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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