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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01933373
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : September 2, 2013
Ersta Hospital, Sweden
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Toupet Procedure: Dor Not Applicable

Detailed Description:
By the end of 2012 40 patients have been enrolled and passed the one year follow up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Toupet
Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.
Procedure: Toupet
Laparoscopic posterior partial fundoplication plus myotomy.
Other Name: Laparascopic posterior partial fundoplication plus myotomy.

Experimental: Dor
Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.
Procedure: Dor
Anterior partial fundoplication plus myotomy.
Other Name: Anterior partial fundoplication plus myotomy.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >18 years of age
  • Typical achalasia according to manometry
  • Eckhardt score >3
  • Informed consent

Exclusion Criteria:

  • Severe comorbidity precluding surgery
  • Pseudo achalasia
  • Inability to participate in follow-up

Information from the National Library of Medicine

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 identifier (NCT number): NCT01933373

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Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Ersta Hospital, Sweden
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Principal Investigator: Lars R Lundell, Professor Gastrocentrum Karolinska University Hospital, Stockholm Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lars Lundell, Professor, Karolinska University Hospital Identifier: NCT01933373     History of Changes
Other Study ID Numbers: 2007/595-32
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by Lars Lundell, Karolinska University Hospital:

Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases