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POEM Anterior Versus Posterior Approach

NCT02454335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-01-02

No results posted yet for this study

Summary

Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal achalasia, performed by GI endoscopist without cutting any surface of the human body. The main constituent of the procedure is the myotomy part, through which the endoscopist cuts the muscle fibers in the submucosa. Since this procedure is completely new to the area of treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be followed up for symptoms and complications; data will be extracted and the appropriate analysis will be employed to determine if there is any difference of outcome between the two techniques of myotomy.

Conditions

  • Achalasia

Interventions

PROCEDURE

Peroral Endoscopic Myotomy

The intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02454335 on ClinicalTrials.gov