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Endometriosis Pelvic Pain Interdisciplinary Cohort Data Registry (EPPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02911090
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2016
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
UBC Department of Obstetrics and Gynaecology
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Paul Yong, BC Women's Hospital & Health Centre

Brief Summary:
The purpose of this data registry is to prospectively collect data from patients referred to an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and endometriosis.

Condition or disease Intervention/treatment
Endometriosis Other: Data Registry

Detailed Description:

The BC Women's Centre for Pelvic Pain and Endometriosis is the tertiary referral centre for endometriosis/pelvic pain in British Columbia, Canada. The Centre offers a unique interdisciplinary approach including minimally invasive surgery, hormonal and other medical therapy, pain education, physiotherapy, and CBT/mindfulness.

After informed consent, patients prospectively consent to data collection in the online registry. The registry consists of patient intake questionnaires (including validated measures), physical and ultrasound examination, review of medical records, surgical findings, and annual outcomes to 5 years.

The online data registry is housed in the Research Electronic Data Capture (REDCap) platform located at BC Children's Hospital.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Endometriosis Pelvic Pain Interdisciplinary Cohort (EPPIC) Data Registry
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Data Registry
    Data Registry


Primary Outcome Measures :
  1. Patient-reported severity of chronic pelvic pain [ Time Frame: 3 months ]
    Measured on a scale of 0 (no pain) to 10 (worst pain imaginable)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the BC Women's Centre for Pelvic Pain and Endometriosis seen for chronic pelvic pain and/ or endometriosis
Criteria

Inclusion Criteria:

  • All new and re-referred patients at the BC Women's Centre for Pelvic Pain and Endometriosis.

Exclusion Criteria:

  • Patients at the BC Women's Centre for Pelvic Pain and Endometriosis seen for reasons other than chronic pelvic pain and/ or endometriosis as well as patients who decline to complete the online questionnaire.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911090


Locations
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Canada, British Columbia
BC Women's Hospital & Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
BC Women's Hospital & Health Centre
UBC Department of Obstetrics and Gynaecology
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Paul Yong, MD PhD FRCSC BC Women's Hospital & Health Centre

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Yong, Research Director, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier: NCT02911090    
Other Study ID Numbers: H16-00264
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paul Yong, BC Women's Hospital & Health Centre:
Endometriosis
Chronic pelvic pain
Dyspareunia
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms