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

August 30, 2013 updated by: Lars Lundell, Karolinska University Hospital

A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dysphagia symptoms according to Eckhardt
Time Frame: up to five years follow up
up to five years follow up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Ersta Hospital, Sweden

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/595-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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