To Assess the Feasibility of Same Day Discharge Following a POEM Procedure (POEM2)
Primary Purpose
Esophageal Achalasia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
POEM
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Achalasia focused on measuring achalasia, surgery
Eligibility 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)
Sites / Locations
- St. Joseph's Healthcare HamiltonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active case
Arm Description
POEM procedure
Outcomes
Primary Outcome Measures
percent of patients leaving on post-operative day 0
Secondary Outcome Measures
percent of patients who experience post-operative reflux
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02572193
Brief Title
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
Acronym
POEM2
Official Title
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Achalasia
Keywords
achalasia, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active case
Arm Type
Experimental
Arm Description
POEM procedure
Intervention Type
Procedure
Intervention Name(s)
POEM
Intervention Description
To determine the feasibility of same-day discharge following a POEM procedure
Primary Outcome Measure Information:
Title
percent of patients leaving on post-operative day 0
Time Frame
1 year
Secondary Outcome Measure Information:
Title
percent of patients who experience post-operative reflux
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Hong, MD
Phone
905-522-1155
Ext
32938
Email
dennishong70@gmail.com
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Hong, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
26416381
Citation
Shiwaku H, Inoue H, Sasaki T, Yamashita K, Ohmiya T, Takeno S, Nimura S, Yamashita Y. A prospective analysis of GERD after POEM on anterior myotomy. Surg Endosc. 2016 Jun;30(6):2496-504. doi: 10.1007/s00464-015-4507-0. Epub 2015 Sep 28.
Results Reference
background
PubMed Identifier
26279840
Citation
Barbieri LA, Hassan C, Rosati R, Romario UF, Correale L, Repici A. Systematic review and meta-analysis: Efficacy and safety of POEM for achalasia. United European Gastroenterol J. 2015 Aug;3(4):325-34. doi: 10.1177/2050640615581732.
Results Reference
background
PubMed Identifier
26206634
Citation
Inoue H, Sato H, Ikeda H, Onimaru M, Sato C, Minami H, Yokomichi H, Kobayashi Y, Grimes KL, Kudo SE. Per-Oral Endoscopic Myotomy: A Series of 500 Patients. J Am Coll Surg. 2015 Aug;221(2):256-64. doi: 10.1016/j.jamcollsurg.2015.03.057. Epub 2015 Apr 11.
Results Reference
background
PubMed Identifier
26200001
Citation
Stavropoulos SN, Modayil R, Friedel D. Per oral endoscopic myotomy for the treatment of achalasia. Curr Opin Gastroenterol. 2015 Sep;31(5):430-40. doi: 10.1097/MOG.0000000000000206.
Results Reference
background
PubMed Identifier
26175119
Citation
Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. 2016 Oct;29(7):807-819. doi: 10.1111/dote.12387. Epub 2015 Jul 14.
Results Reference
background
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To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
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