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

Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01933373
Collaborator
Ersta Hospital, Sweden (Other)
25
Enrollment
1
Location
2
Arms
67.1
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Toupet
  • Procedure: Dor
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
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 1, 2007
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Toupet

Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.

Procedure: Toupet
Laparoscopic posterior partial fundoplication plus myotomy.
Other Names:
  • 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 Names:
  • Anterior partial fundoplication plus myotomy.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dysphagia symptoms according to Eckhardt [up to five years follow up]

    Secondary Outcome Measures

    1. Ambulatory esophageal PH [One and five years follow up]

    2. Health-related quality of life according to Velanovich [One and five years follow up]

    3. Timed barium esophagogram at 1, 2 and 5 minutes [One and five years follow up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska University Hospital Stockholm Sweden 14186

    Sponsors and Collaborators

    • Karolinska University Hospital
    • Ersta Hospital, Sweden

    Investigators

    • Principal Investigator: Lars R Lundell, Professor, Gastrocentrum Karolinska University Hospital, Stockholm Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lars Lundell, Professor, Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT01933373
    Other Study ID Numbers:
    • 2007/595-32
    First Posted:
    Sep 2, 2013
    Last Update Posted:
    Sep 2, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Lars Lundell, Professor, Karolinska University Hospital
    Randomized
    Toupet
    Dor
    Achalasia
    Additional relevant MeSH terms:
    Esophageal Achalasia

    Study Results

    No Results Posted as of Sep 2, 2013