๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-01-11

Endometriosis and Health Care System Utilization in British Columbia (NCT06217315)

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: BC Women's Hospital & Health Centre

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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. 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).

Who can join: Review the eligibility criteria below.

Location: BC Women's Hospital + Health Centre โ€” Vancouver, British Columbia

๐Ÿงช Interventions in This Study

  • No Intervention (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • BC Women's Hospital + Health Centre โ€” Vancouver, British Columbia

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Endometriosis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—