Clinical Trials in Spain / NCT07282990
Starting soon
Observational
Evolution of Endometriosis Lesions Followed by Ultrasound and Quality of Life of Patients: Factors That Influence Disease Progression in a Prospective Cohort
NCT07282990 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Endometriosis
Study summary
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.
Eligibility
Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. 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.
5. Signed informed consent from the patient, indicating that she has understood the purpose of the study, the procedures involved, and the potential risks.
Exclusion Criteria:
1. 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.
2. 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.
3. 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.
4. 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.
5. Patients who are pregnant or breastfeeding at the time of enrollment. These conditions can influence the course of endometriosis and the response to treatment, and could complicate disease monitoring.
6. Patients with serious concurrent illnesses or medical conditions that may interfere with the assessment of endometriosis, its progression, or the impact of treatment (e.g., severe chronic inflammatory diseases or cancer).
7. Patients receiving concurrent treatments not permitted by the study protocol (e.g., experimental treatments for endometriosis or related conditions) that may interfere with the interpretation of the results.
Primary outcome measure(s)
- Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months — From enrollment to the end of follow-up at 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 — From enrollment to the end of follow-up at 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")
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07282990 on ClinicalTrials.gov ↗ ← All trials in Spain