Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)
|ClinicalTrials.gov Identifier: NCT02138643|
Recruitment Status : Unknown
Verified April 2017 by University of Sao Paulo General Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 14, 2014
Last Update Posted : April 12, 2017
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 ) .
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia Achalasia||Procedure: Endoscopic surgery Procedure: Laparoscopic surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM)|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Endoscopic surgery
Patients with symptomatic achalasia confirmed by clinical and laboratory tests, which meet the criteria for inclusion and exclusion. These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)
Procedure: Endoscopic surgery
These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)
Sham Comparator: Laparoscopic surgery
Patients with symptomatic achalasia confirmed by clinical and laboratory tests, which meet the criteria for inclusion and exclusion. These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.
Procedure: Laparoscopic surgery
These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.
- Remission of symptoms dysphagia. [ Time Frame: 12 months after the procedure performed. ]Patient selection will last for six months after the beginning of the study. Six months later, conduct additional examinations and randomization. Twelve months after the start of the project will be the completion of endoscopic surgery or laparoscopic surgery for resolution of dysphagia. The measure is a composite.
- Running time of the procedure and hospitalization. [ Time Frame: Starts 12 months after procedure performed. ]New outpatient medical visits for clinical reassessment, more precisely 30 days, 3 months, 6 months and 12 months after the procedure will be scheduled to measure the execution time of the procedure and hospitalization. The measure is a composite.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138643
|Hospital das Clínicas da FMUSP|
|São Paulo, SP, Brazil, 05403000|
|Principal Investigator:||Paulo Sakai||Hospital das Clínicas da FMUSP|
|Study Director:||Eduardo Turiani H de Moura||Hospital das Clínicas FMUSP|