A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
|ClinicalTrials.gov Identifier: NCT00188344|
Recruitment Status : Unknown
Verified May 2014 by University Health Network, Toronto.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : May 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Procedure: pneumatic dilatation Procedure: laparoscopic myotomy with partial fundoplication||Not Applicable|
Achalasia is a rare disease of the esophagus. It can cause difficulty swallowing, regurgitation of swallowed food, and chest pain. In achalasia, there are two problems in the esophagus. First, the esophagus does not properly push swallowed food down towards the stomach. Second, the valve at the lower end of the esophagus, called the lower esophageal sphincter, does not relax to allow food to pass from the esophagus into the stomach.
Achalasia cannot be "cured". However, the symptoms of achalasia can be improved by treatment. Treatment is usually directed towards reducing the degree of blockage caused by the lower esophageal sphincter. the muscle of the lower esophageal sphincter can be stretched using a technique called pneumatic dilatation, or it can be divided (cut in half) during a surgical operation. The operation is called laparoscopic Heller myotomy, and is done by laparoscopic ("keyhole") surgery, where small incisions are used and patients usually stay in hospital 1-2 nights. Other treatments for achalasia, such as medications or injection of Botulinum Toxin Type A are not often used because they do not provide effective long-term improvement.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||March 2015|
Active Comparator: 1
Procedure: pneumatic dilatation
The patient is on a liquid diet for 2 days prior to procedure. A sedative and pain killer by IV are given and the throat will be sprayed with local anesthetic.
The gastroenterologist may perform an endoscopy prior to the dilatation to safely guide the dilator into position. A special dilator with a small balloon will be passed down the esophagus until it meets the stomach then the balloon will be inflated with air until the narrow part of the esophagus is opened. The patient will then be assessed for any perforation of the esophagus and monitored in the post-procedure unit for a few hours.
Active Comparator: 2
Procedure: laparoscopic myotomy with partial fundoplication
The abdomen is inflated with gas and cameras and instruments are inserted. The junction between the esophagus and stomach is identified. The muscle of the lower esophageal sphincter is divided. A portion of the stomach wall is secured to the lower esophagus. After surgery the patient is taken to the recovery room and when well enough moved to a ward. The patient may be discharged the following day.
- The achalasia severity questionnaire score at 1 year. [ Time Frame: Baseline, M2, M6, Yrs 1 to 5 ]
- Generic health related quality of life (SF-36) [ Time Frame: baseline, M2, M6, Yrs 1 to 5 ]
- Gastrointestinal disease-specific quality of life (GIQLI) [ Time Frame: baseline, M2, M6, Yrs 1 to 5 ]
- Measures of esophageal physiology [ Time Frame: baseline, M6 ]
- Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement [ Time Frame: M6 ]
- Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes. [ Time Frame: Yrs 1 to 5 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188344
|St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing|
|Toronto, Ontario, Canada, M5B 1W8|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||David R Urbach, MD||University Health Network, Toronto|