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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01799967
First received: February 25, 2013
Last updated: November 17, 2016
Last verified: November 2016
  Purpose
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.

Condition
Achalasia
Paraesophageal Hernia
GERD
Epiphrenic Diverticula
Zenker's Diverticulum

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • MISGEJ symptoms (subjective) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    MISGEJ symptom questionnaire evaluated on an annual basis

  • Achalasia Disease Severity (subjective) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    Achalasia Disease Severity questionnaire evaluated on an annual basis.

  • Diagnostic imaging [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 18 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799967

Contacts
Contact: Andrew JE Seely, MD, PhD 613-737-8899 ext 74892 aseely@ohri.ca

Locations
Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H8L6
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         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Andrew JE Seely, MD, PhD Ottawa Hospital Research Institute
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01799967     History of Changes
Other Study ID Numbers: 2007173-01H 
Study First Received: February 25, 2013
Last Updated: November 17, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:
gastro-esophageal junction
minimally invasive
Achalasia
Paraesophageal hernia
GERD
Epiphrenic diverticula
Zenker's diverticulum
All minimally invasive surgeries of the gastro-esophageal junction

Additional relevant MeSH terms:
Esophageal Achalasia
Hernia
Hernia, Hiatal
Diverticulum
Zenker Diverticulum
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic
Diverticulum, Esophageal

ClinicalTrials.gov processed this record on December 02, 2016