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

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933373
• Other study ID #: 2007/595-32
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: August 30, 2013
• Start date: May 2007
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Ersta Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia symptoms according to Eckhardt		up to five years follow up	No
Secondary	Ambulatory esophageal PH		One and five years follow up	No
Secondary	Health-related quality of life according to Velanovich		One and five years follow up	No
Secondary	Timed barium esophagogram at 1, 2 and 5 minutes		One and five years follow up	No