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

NCT01933373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-09-02

No results posted yet for this study

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.

Conditions

  • Achalasia

Interventions

PROCEDURE

Toupet

Laparoscopic posterior partial fundoplication plus myotomy.

PROCEDURE

Dor

Anterior partial fundoplication plus myotomy.

Sponsors & Collaborators

  • Ersta Hospital, Sweden

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Lars R Lundell, Professor · Gastrocentrum Karolinska University Hospital, Stockholm Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933373 on ClinicalTrials.gov