NCT01799967

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Nov 2007Nov 2027

Study Start

First participant enrolled

November 1, 2007

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
14.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 30, 2026

Status Verified

December 1, 2024

Enrollment Period

20 years

First QC Date

February 25, 2013

Last Update Submit

January 28, 2026

Conditions

GERDEpiphrenic DiverticulaZenker's DiverticulumAchalasiaParaesophageal Hernia

Keywords

gastro-esophageal junctionminimally invasiveAchalasiaParaesophageal herniaGERDEpiphrenic diverticulaZenker's diverticulumAll minimally invasive surgeries of the gastro-esophageal junction

Outcome Measures

Primary Outcomes (3)

  • MISGEJ symptoms (subjective)

    MISGEJ symptom questionnaire evaluated on an annual basis

    8 years

  • Achalasia Disease Severity (subjective)

    Achalasia Disease Severity questionnaire evaluated on an annual basis.

    8 years

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Esophageal AchalasiaHernia, HiatalGastroesophageal RefluxZenker Diverticulum

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDiverticulum, EsophagealDiverticulumDiverticular DiseasesGastroenteritis

Study Officials

  • Andrew JE Seely, MD, PhD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

November 1, 2007

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

January 30, 2026

Record last verified: 2024-12

Locations

CA(1)