Minimally Invasive Surgery of the Gastro-esophageal Junction

Recruiting

• Conditions: Achalasia; Epiphrenic Diverticula; GERD; Zenker's Diverticulum; Paraesophageal Hernia

• Registration Number: NCT01799967
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MISGEJ symptoms (subjective)	8 years	MISGEJ symptom questionnaire evaluated on an annual basis
Achalasia Disease Severity (subjective)	8 years	Achalasia Disease Severity questionnaire evaluated on an annual basis.
Diagnostic imaging	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.

Trial Locations

Locations (1)

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada