Minimally Invasive Surgery of the Gastro-esophageal Junction (MISGEJ)

March 28, 2023 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrew JE Seely, MD, PhD
  • Phone Number: 74892 613-737-8899
  • Email: aseely@ohri.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Sub-Investigator:
          • Donna E Maziak, MD, MSc
        • Sub-Investigator:
          • Sebastien Gilbert, MD
        • Sub-Investigator:
          • Sudhir Sundaresan, MD
        • Sub-Investigator:
          • Shamji Farid, MD
        • Sub-Investigator:
          • Patrick James Villeneuve, MD, PhD
        • Principal Investigator:
          • Andrew JE Seely, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.

Description

Inclusion Criteria:

  • All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ

Exclusion Criteria:

  • Less than 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MISGEJ symptoms (subjective)
Time Frame: 8 years
MISGEJ symptom questionnaire evaluated on an annual basis
8 years
Achalasia Disease Severity (subjective)
Time Frame: 8 years
Achalasia Disease Severity questionnaire evaluated on an annual basis.
8 years
Diagnostic imaging
Time Frame: 8 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Andrew JE Seely, MD, PhD, Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

November 1, 2027

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007173-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on GERD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe