A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
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|ClinicalTrials.gov Identifier: NCT01933373|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : September 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Procedure: Toupet Procedure: Dor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
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.
- Dysphagia symptoms according to Eckhardt [ Time Frame: up to five years follow up ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933373
|Karolinska University Hospital|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Lars R Lundell, Professor||Gastrocentrum Karolinska University Hospital, Stockholm Sweden|