MISGEJ: Minimally Invasive Surgery of the Gastro-esophageal Junction

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT01799967

Collaborator

(none)

200

Enrollment

Location

240

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia Paraesophageal Hernia GERD Epiphrenic Diverticula Zenker's Diverticulum

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Nov 1, 2027

Anticipated Study Completion Date :

Nov 1, 2027

Outcome Measures

Primary Outcome Measures

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.