Clinical Trial: A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

Brief Summary: The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy in patients with achalasia in order to learn which of these two treatments should be recommended to patients in the future.

Detailed Summary:

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.


Sponsor: University Health Network, Toronto

Current Primary Outcome: The achalasia severity questionnaire score at 1 year. [ Time Frame: Baseline, M2, M6, Yrs 1 to 5 ]

Original Primary Outcome: The achalasia severity questionnaire score at 1 year.

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Generic health related quality of life (SF-36)
  • Gastrointestinal disease-specific quality of life (GIQLI)
  • Measures of esophageal physiology
  • Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement
  • Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes.


Information By: University Health Network, Toronto

Dates:
Date Received: September 9, 2005
Date Started: September 2005
Date Completion: March 2015
Last Updated: May 20, 2014
Last Verified: May 2014