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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: L. Michael Brunt

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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: June 21, 2007
Date Started: March 2003
Date Completion:
Last Updated: December 7, 2015
Last Verified: December 2015