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

L

L. Michael Brunt

Status

Completed

Conditions

Esophageal Achalasia

Treatments

Procedure: Toupet fundoplication
Procedure: Dor fundoplication

Study type

Interventional

Funder types

Other

Identifiers

NCT00490750
03-0241

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Diagnosis of Achalasia

Exclusion criteria

  • Prior heller myotomy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

60 participants in 2 patient groups

Laparoscopic Dor fundoplication
Active Comparator group
Description:
Heller myotomy followed by Dor fundoplication
Treatment:
Procedure: Dor fundoplication
Laparoscopic Toupet fundoplication
Active Comparator group
Description:
Heller myotomy followed by Toupet fundoplication
Treatment:
Procedure: Toupet fundoplication

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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