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EndometriosisEndoCareNCT06217315

Endometriosis and Health Care System Utilization in British Columbia

An observational study of Endometriosis, run by BC Women's Hospital & Health Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Purpose \& Background Endometriosis is a chronic inflammatory condition believed to affect 8-10% of reproductive-age women and an unmeasured number of gender-diverse people. It is a common cause of pelvic pain and infertility, is now known to be associated with other conditions such as heart disease and ovarian cancer… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis
How many people
1,000,000 participants
Where
1 siteCanada
Study dates
18 Oct 2022to 30 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The cohort will consist of all females in British Columbia between January 1st 2000 and December 31st 2021 as identified by the Consolidation File Dataset available by Population Health Data BC.

The cohort will consist of all females in British Columbia between January 1st 2000 and December 31st 2021 as identified by the Consolidation File Dataset available by Population Health Data BC.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • BC Women's Hospital + Health Centre

    Vancouver, British Columbia, V6H 2N9

Other trials in Canada

About this study

Purpose \& Background Endometriosis is a chronic inflammatory condition believed to affect 8-10% of reproductive-age women and an unmeasured number of gender-diverse people. It is a common cause of pelvic pain and infertility, is now known to be associated with other conditions such as heart disease and ovarian cancer and can have a devastating impact on a woman's ability to function and achieve their full potential. It has been shown that endometriosis and chronic pelvic pain are associated with considerable costs to the health-care system in Canada. The in-patient hospital costs for chronic pelvic pain were estimated to be $25 million/year and the total societal costs for endometriosis were estimated to be 1.8 billion/year.

Standard therapies for endometriosis and pelvic pain include pain medications, hormonal suppressive therapies, and surgery. There is a tertiary referral centre of excellence for endometriosis at BC Women's Hospital (Centre for Pelvic Pain and Endometriosis), which provides advanced surgical treatment of endometriosis and interdisciplinary care for patients with endometriosis who have developed other pain comorbidities (e.g. due to central nervous system sensitization). Central sensitization responds best to treatments targeted to the nervous system, such as Interdisciplinary care includes pain education, physiotherapy, and mindfulness-based cognitive therapies. One randomized trial has shown the benefit of an interdisciplinary approach compared to standard treatment for the management of chronic pelvic pain. At our centre, the investigators reported improvements in pain, mental health, quality-of-life, and self-reported reduction in health care utilization, after interdisciplinary care, utilizing our ongoing prospective registry. However, a formal economic analysis of health care system utilization is required to quantify savings to the health care system with an interdisciplinary approach to endometriosis.

Read more

Despite surgery being a common treatment of endometriosis, there is variability in outcome and a gap is the lack of ability to predict outcomes after endometriosis surgery. For example, utilizing self-reported outcomes from our registry, the investigators found that poorer outcome after endometriosis surgery was found in patients with evidence of pain comorbidities and central sensitization (as surgery is not a direct treatment of these factors) (in preparation). Moreover, the investigators have a biobank and have been studying biomarkers in surgically excised endometriosis tissue that may predict outcomes after surgery. These biomarkers include somatic cancer driver mutations and neuroinflammation. The investigators have preliminary data that suggests that these biomarkers may predict rates of re-operation at the centre. Beyond self-reported outcomes and re-operation at the centre, there is a need to assess health care utilization and re-operation occurring throughout the province as additional outcomes that may be associated with our clinical and biomarker predictors.

Finally, the SARS-CoV-2 (COVID-19) pandemic has had profound physical and mental health effects on populations worldwide. However, there exists limited empirical evidence focusing on the wellbeing of patients with endometriosis and/or pelvic pain during the public health crisis. Herein, the investigators propose to compare a pre-pandemic cohort to a pandemic cohort of subjects with endometriosis and/or chronic pelvic pain, again in terms of health care system utilization.

Therefore, the overall purpose of this project is to assess health care utilization patterns of patients with endometriosis in British Columbia, and to perform an economic analysis of interdisciplinary care, evaluate clinical-biomarker predictors of surgical outcome, and assess the impact of the covid pandemic. This will be achieved by linking Population Data BC datasets to our ongoing prospective registry (H16-00264) and prospective and retrospective biobanks (H14-03040, H17-00329).

Read the detailed description

HYPOTHESIS Aim 1: The investigators hypothesize that health care costs for patients being cared for in our clinic will be higher in the three years preceding their time with us than the years following their discharge. The investigators hypothesize that the overall cost of the interdisciplinary clinic, including physiotherapist, counsellor and nurse salaries and administrative support, will be less than overall cost savings to the system from reduced utilization of health care resources after discharge.

Aim 2: The investigators hypothesize that comorbidities associated with central nervous system sensitization and biomarkers including somatic mutations and local neurogenesis/neuroinflammation are linked to persistent pain and disease recurrence after endometriosis surgery, which results in increased risk of re-operation and health care utilization after surgery.

Aim 3: The pandemic cohort will have increased health care system utilization, and also poorer health system outcomes after care the centre.

Aim 4: People with endometriosis, utilizing different case definitions, will experience higher health care use and worse pregnancy outcomes, compared to people without endometriosis.

Conditions
Endometriosis
Being tested
No Intervention
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    There is no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Economic Impact

    To assess the cost-effectiveness of an interdisciplinary model of care for endometriosis by measuring the cost of healthcare services as determined by BC Medical Service Plan billing codes.

    Measured: Jan 1st 2000 - Dec 31st 2021

  2. Prediction Model

    To identify clinical and biomarker predictors and quality of life after surgery as measured by the Endometriosis Health Profile (EHP-30).

    Measured: Jan 1st 2000 - Dec 31st 2021

  3. Covid pre-post outcomes

    To determine the impact of the COVID-19 pandemic on health care system utilization of patients with endometriosis by measuring clinical biomarkers, KRAS mutations and quality of life outcomes (EHP-30, GAD-7, PHQ-9, Central Sensitization Inventory CSI) before and after the pandemic.

    Measured: Jan 1st 2000 - Dec 31st 2021

  4. Impact of Health Care Utilization

    To understand the overall impact of endometriosis on health care use, including with respect to surgical and pregnancy outcomes as measured by number of surgical operations, medication use and live birth rates.

    Measured: Jan 1st 2000 - Dec 31st 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start18 Oct 2022
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06217315
Sponsor's protocol ID
H21-01699
Other IDs
2023-06565, 2023
Acronym
EndoCare
Status last verified
Aug 2026
First submitted
2 Jan 2024
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Metadata can be shared with other researchers. Raw data is restricted.

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by BC Women's Hospital & Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Economic Impact (time frame: Jan 1st 2000 - Dec 31st 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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