| June 21, 2007 |
| February 3, 2009 |
| March 2003 |
| March 2010 (final data collection date for primary outcome measure) |
| Primary outcomes are 24 hour pH testing results [ Time Frame: pH testing at 6-12 months after surgical treatment ] [ Designated as safety issue: No ] |
| Primary outcomes are 24 hour pH testing results [ Time Frame: pH testing at 6-12 months after surgical treatment ] |
| Complete list of historical versions of study NCT00490750 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs [ Time Frame: 6-12 months after surgical intervention ] |
| |
| Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia |
| Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial 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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Bio-equivalence Study |
| Esophageal Achalasia |
- Procedure: Dor fundoplication
- Procedure: Toupet fundoplication
|
- Active Comparator: Heller myotomy followed by Dor fundoplication
- Active Comparator: Heller myotomy followed by Toupet fundoplication
|
| |
| |
| Recruiting |
| 200 |
| March 2010 |
| March 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
|
| Both |
| 18 Years and older |
| Yes |
|
|
| United States |
| |
| NCT00490750 |
| Nathaniel Soper, MD, Chiarman, Surgery, Northwestern University Medical School |
| 03-0241 |
| Washington University School of Medicine |
- University of Washington
- Northwestern University
- University of Oregon
- Duke University
|
| Principal Investigator: |
L. Michael Brunt, MD |
Washington University School of Medicine |
|
|
| Washington University School of Medicine |
| February 2009 |
