A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.|
- Dysphagia symptoms according to Eckhardt [ Time Frame: up to five years follow up ] [ Designated as safety issue: No ]
- Ambulatory esophageal PH [ Time Frame: One and five years follow up ] [ Designated as safety issue: No ]
- Health-related quality of life according to Velanovich [ Time Frame: One and five years follow up ] [ Designated as safety issue: No ]
- Timed barium esophagogram at 1, 2 and 5 minutes [ Time Frame: One and five years follow up ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Toupet
Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.
Laparoscopic posterior partial fundoplication plus myotomy.
Other Name: Laparascopic posterior partial fundoplication plus myotomy.
Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.
Anterior partial fundoplication plus myotomy.
Other Name: Anterior partial fundoplication plus myotomy.
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933373
|Karolinska University Hospital|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Lars R Lundell, Professor||Gastrocentrum Karolinska University Hospital, Stockholm Sweden|