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

Brief Title

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

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 Description

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


Study Type

Interventional


Primary Outcome

Dysphagia symptoms according to Eckhardt

Secondary Outcome

 Ambulatory esophageal PH

Condition

Achalasia

Intervention

Toupet

Study Arms / Comparison Groups

 Toupet
Description:  Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

25

Start Date

May 2007

Completion Date

December 2012

Primary Completion Date

December 2011

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Lars R Lundell, Professor, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT01933373

Organization ID

2007/595-32


Responsible Party

Principal Investigator

Study Sponsor

Karolinska University Hospital

Collaborators

 Ersta Hospital, Sweden

Study Sponsor

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


Verification Date

August 2013