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Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)

NCT02138643 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-12

No results posted yet for this study

Summary

Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax the lower esophageal sphincter ( LES) in response to swallowing associated with lack of peristalsis of the esophageal body. Its most common clinical presentation is dysphagia , and occasionally chest pain , regurgitation , aspiration pneumonia and weight loss , resulting in a large impact on daily activities and quality of life of affected individuals .

There is currently considered curative treatment for achalasia , dysphagia relief being the primary therapeutic target and is forced to relax the LES by endoscopy or surgery. Thus , the most commonly used endoscopic treatments are forced dilatation of the cardia and botulinum toxin. Laparoscopic Heller myotomy with antireflux procedure with therapy is considered "gold standard " because of excellent results and minimal invasiveness. Currently , pneumatic dilation and surgical treatment with the Heller myotomy with fundoplication are strongly associated with the best therapeutic options available .

In recent years, the possibility of using endoluminal access in the treatment of achalasia patients through the technique originally described as Natural orifices Translumenal Endoscopic Surgery ( NOTES) and continuing advances in the submucosal dissection has enabled the concomitant development of a new approach described as perioral endoscopic myotomy . In 2007, Pasricha et al , described the feasibility of endoscopic esophageal myotomy through a submucosal tunnel initially in an animal model . The first performance of this procedure in humans was described by Inoue et al , in 2010 , introducing the concept of transluminal endoscopic surgery through natural orifices , with the objective of minimizing the trauma and all the stress resulting from open surgical procedure . These authors call the procedure as POEM ( Per Oral Endoscopic myotomy ) .

Conditions

Interventions

PROCEDURE

Endoscopic surgery

These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)

PROCEDURE

Laparoscopic surgery

These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Paulo Sakai · Hospital das Clínicas da FMUSP

  • Eduardo Turiani H de Moura · Hospital das Clínicas FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT02138643 on ClinicalTrials.gov