The goal of this prospective cohort study is to determine the factors that influence the progression of endometriosis and the quality of life of patients.
The main questions it aims to answer are:
1. Is endometriosis a progressive disease? 2. Is the progression of lesions visualized by ultrasound dependent on the medical treatment received? 3. Does the clinical progression of patients correlate with the progression of lesions visualized on transvaginal ultrasound? 4. Is ultrasound follow-up necessary for patients? 5. Could clinical follow-up alone be safe for selected patients?
Researchers will follow up a prospective cohort of 100 patients diagnosed with deep infiltrating endometriosis (DIE) +/- endometriomas during 2 years, collecting data regarding their ultrasound exam and their symptoms and quality of life at stablished controls at recruitment, 6 months, 12 months and 24 months.
Women with a confirmed diagnosis of endometriosis, based on ultrasound criteria. Diagnosis must be confirmed by transvaginal ultrasound with evidence of visible and measurable endometriotic lesions.
Patients over 18 years of age. This criterion ensures that participants can provide informed consent and are of reproductive age, when the effects of endometriosis and its treatments are relevant to the study.
A transvaginal ultrasound performed prior to enrollment showing endometriotic lesions (either endometriomas or deep lesions) with sufficient dimensions and characteristics for evaluation and follow-up.
Patients who do not have an indication for scheduled surgery within the next two years. This ensures that the effects of treatment and the progression of the disease can be evaluated throughout the study follow-up period.
Patients with an indication for scheduled surgical treatment within the next two years. This includes patients requiring surgery for the removal of endometriotic lesions or to address related complications.
Patients who are unwilling to undergo follow-up transvaginal ultrasound at scheduled visits (6 months, 1 year, 2 years). Ultrasound is essential for assessing disease progression and the impact of treatment.
Patients who are unwilling to participate in the study after receiving all the information and providing their informed consent. Voluntary participation is crucial for the ethics of the study.
Patients with intellectual disabilities or conditions that impair their understanding of the study terms and procedures, which could affect their ability to provide valid informed consent.
Women who are referred to Hospital de la Santa Creu i Sant Pau (Barcelona) due to a clinical or sonographic suspicion of endometriosis.
Cohort
Prospective
Not listed
Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months
* Ultrasound data used: * Number of lesions (endometriomas and DIE lesions). * Size (assessed in mm; 3 diameters) and characteristics of endometriomas and DIE lesions (described according to IDEA criteria). * Presence or absence of hydronephrosis, adhesions, and hydrosalpinx. * Ultrasound classification according to Enzian Clssification. Outcome variable: PROGRESSION, STABILITY or REGRESSION. This result will be defined as follows: * PROGRESSION: Increase of \> 5mm in the maximum lesion measurement and/or appearance of new lesions and/or increase of 1 point in any item of the Enzian classification. * STABILITY: increase/decrease \<5mm in the maximum lesion measurement and same number of identified lesions and no changes in the score of any item of the Enzian classification. * REGRESSION: decrease \> 5mm in the maximum lesion measurement and/or disappearence of any of the previously described lesions and/or decrease of 1 point in any item of the Enzian classification.
Evolution of clinical presentation at recruitment, 6, 12 and 24 months
* Symptoms: numeric pain rating scale (zero is equivalent to no pain and 10 indicates the worst possible pain) * Dysmenorrhea * Chronic pelvic pain * Dyschezia * Dyspareunia * Dysuria * Subjective evolution according to patient impressions: Likert scale ("significant improvement" / "moderate improvement" / "stability" / "mild worsening" / "significant worsening")
Evolution of Ovarian Reserve at recruitment, 6, 12 and 24 months
Measures: * Anti-Müllerian Hormone (AMH) serum level (at first visit and follow-up). * Antral Follicle Count (AFC) assessed by transvaginal ultrasound (at first visit and follow-up). Outcome variable: OVARIAN RESERVE LOSS (YES / NO) Decreased ovarian reserve will be considered when AMH presents with a drop of 0.2 ng/mL annually, and/or if AMH if below 1 ng/dL at any time during follow-up, and/or AFC falls \>=4 follicles anually.
Evolution of Quality of Life (QoL) at recruitment, 6, 12 and 24 monts
\- Quality of life measurement using the Endometriosis Health Profile-30 (EHP-30) questionnaire (at first visit and follow-up). The EHP-30 consists of a core instrument which includes five scale scores covering: * Pain (11 items) * Control and powerlessness (6 items) * Social support (4 items) * Emotional well-being (6 items) * Self-image (3 items) Each item is answered as a categorical Likert-Scale (Never, Rarely, Sometimes, Often, Always). It is a self-reported questionnaire which will be administered on paper support.
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