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Completed

NCT Number: NCT00490750

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

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.

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Key information

Conditions

Esophageal Achalasia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Achalasia

Exclusion criteria

  • Prior heller myotomy

Treatment and study plan

Dor fundoplication

Procedure

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

Toupet fundoplication

Procedure

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

Primary outcomes

  1. Primary outcomes are 24 hour pH testing results

    Time frame: pH testing at 6-12 months after surgical treatment

Secondary outcomes

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

    Time frame: 6-12 months after surgical intervention

Sponsors and collaborators

Lead sponsor

L. Michael Brunt

Other

Collaborators

  • Duke University
  • Northwestern University
  • University of Oregon
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Jun 25, 2007
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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