Clinical Trial: A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia

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

Official Title: A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

Brief Summary: Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.

Detailed Summary: By the end of 2012 40 patients have been enrolled and passed the one year follow up.
Sponsor: Karolinska University Hospital

Current Primary Outcome: Dysphagia symptoms according to Eckhardt [ Time Frame: up to five years follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ambulatory esophageal PH [ Time Frame: One and five years follow up ]
  • Health-related quality of life according to Velanovich [ Time Frame: One and five years follow up ]
  • Timed barium esophagogram at 1, 2 and 5 minutes [ Time Frame: One and five years follow up ]


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: June 19, 2013
Date Started: May 2007
Date Completion:
Last Updated: August 30, 2013
Last Verified: August 2013