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A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

NCT00188344 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-05-21

No results posted yet for this study

Summary

The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy in patients with achalasia in order to learn which of these two treatments should be recommended to patients in the future.

Conditions

  • Esophageal Achalasia

Interventions

PROCEDURE

pneumatic dilatation

The patient is on a liquid diet for 2 days prior to procedure. A sedative and pain killer by IV are given and the throat will be sprayed with local anesthetic. The gastroenterologist may perform an endoscopy prior to the dilatation to safely guide the dilator into position. A special dilator with a small balloon will be passed down the esophagus until it meets the stomach then the balloon will be inflated with air until the narrow part of the esophagus is opened. The patient will then be assessed for any perforation of the esophagus and monitored in the post-procedure unit for a few hours.

PROCEDURE

laparoscopic myotomy with partial fundoplication

The abdomen is inflated with gas and cameras and instruments are inserted. The junction between the esophagus and stomach is identified. The muscle of the lower esophageal sphincter is divided. A portion of the stomach wall is secured to the lower esophagus. After surgery the patient is taken to the recovery room and when well enough moved to a ward. The patient may be discharged the following day.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • David R Urbach, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2011-03-31
Completion
2015-03-31

Countries

  • Canada

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 NCT00188344 on ClinicalTrials.gov