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

Not Applicable

• Conditions: Esophageal Achalasia
• Interventions: Procedure: POEM

• Registration Number: NCT02572193
• Lead Sponsor: McMaster University

Brief Summary

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

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active case	POEM	POEM procedure

Primary Outcome Measures

Name	Time	Method
percent of patients leaving on post-operative day 0	1 year

Secondary Outcome Measures

Name	Time	Method
percent of patients who experience post-operative reflux	1 year

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada