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NCT01799967 Clinical Trial

Minimally Invasive Surgery of the Gastro-esophageal Junction

GERD Clinical Trial

— MISGEJ  

Official title:
Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01799967
Other study ID # 2007173-01H
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2007
Est. completion date November 2027

Study information
Verified date March 2023
Source Ottawa Hospital Research Institute
Contact Andrew JE Seely, MD, PhD
Phone 613-737-8899
Email aseely@ohri.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date November 2027
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ Exclusion Criteria: - Less than 18 years of age.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Ottawa Hospital Research Institute Ottawa Ontario

Sponsors (1)
Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary MISGEJ symptoms (subjective) MISGEJ symptom questionnaire evaluated on an annual basis 8 years
Primary Achalasia Disease Severity (subjective) Achalasia Disease Severity questionnaire evaluated on an annual basis. 8 years
Primary Diagnostic imaging Patient x-rays, upper GI tests, Endoscopy, and/or CT scans will be assessed on an annual basis to objectively measure functionality and health status. 8 years
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