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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Esophageal Achalasia Procedure: POEM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active case
POEM procedure
Procedure: POEM
To determine the feasibility of same-day discharge following a POEM procedure




Primary Outcome Measures :
  1. percent of patients leaving on post-operative day 0 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. percent of patients who experience post-operative reflux [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Dennis Hong, MD 905-522-1155 ext 32938 dennishong70@gmail.com

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Dennis Hong, MD         
Sponsors and Collaborators
McMaster University
Publications:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02572193    
Other Study ID Numbers: 2015H1
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Keywords provided by McMaster University:
achalasia
surgery
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases