Esophageal Achalasia Clinical Trial
Official title:
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being performed to determine if patients can go home on the same day as their procedure.
This is a study of an investigational surgical procedure for the treatment of achalasia the
inability of smooth muscle to move food down the esophagus.
Standard care for participants includes Heller Myotomy, a laparoscopic procedure that
includes cutting the muscle layers in the lower esophageal sphincter (LES) the valve at the
bottom of your esophagus. A second procedure is then required to prevent reflux (acid
entering the esophagus from the stomach) called fundoplication. Patients with the Heller
myotomy will typically stay overnight in hospital. A new procedure, called the POEM
procedure (per oral endoscopic myotomy) has been developed for achalasia. This procedure
uses endoscopy and no incisions to cut one muscle layer. A fundoplication is not required
with this method. This study treatment works by entering the surgical area through the mouth
and then making an incision (cut) through the esophagus and placing flexible instruments
along the outside of the esophagus and down to the LES through a tunnel. The instruments
used in this procedure are standard endoscopic instruments that will be provided by one of
the leading endoscopic instrument manufacturers, Olympus. The investigators have recently
completed a small study showing this procedure is safe and feasible. One observation from
this pilot study was that most patients had no pain and didn't need any pain medications.
Due to this reason, the investigators think patient's may go home on the same day as their
procedure.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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