To Assess the Feasibility of Same Day Discharge Following a POEM Procedure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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To Assess the Feasibility of Same Day Discharge Following a POEM Procedure

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: POEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet ALL of the following inclusion criteria: Candidate for a Heller myotomy Their age is ≥18 years and ≤80 years Able to give written consent Exclusion Criteria: Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study: Previous Heller myotomy or POEM procedure contra-indication to general anesthesia Previous mediastinal surgery hiatal hernia greater than 2 cm Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia > 2cm. Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active case<br>POEM procedure | Procedure: POEM<br>* To determine the feasibility of same-day discharge following a POEM procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients leaving on post-operative day 0 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients who experience post-operative reflux |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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achalasia, surgery