To Assess the Feasibility of Same Day Discharge Following a POEM Procedure (POEM2)
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|ClinicalTrials.gov Identifier: NCT02572193|
Recruitment Status : Unknown
Verified December 2016 by McMaster University.
Recruitment status was: Recruiting
First Posted : October 8, 2015
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Procedure: POEM||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Assess the Feasibility of Same Day Discharge Following a POEM Procedure|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Active case
To determine the feasibility of same-day discharge following a POEM procedure
- percent of patients leaving on post-operative day 0 [ Time Frame: 1 year ]
- percent of patients who experience post-operative reflux [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572193
|Contact: Dennis Hong, MD||905-522-1155 ext email@example.com|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator: Dennis Hong, MD|