Operatieve of medicamenteuze behandeling van vrouwen met een endometrioom.
Recruiting
- Conditions
- - Endometrioma/Endometrioom- Medical treatment vs Surgical treatment/ Medicamenteuze vs Chirurgische behandeling- Pain/ Pijn- Quality of Life/ Kwaliteit van leven- Affective symptoms/ Affectieve klachten- Cost efficacy/ Kosteneffectiviteit- Ovarian reserve/ Ovariële reserve
- Registration Number
- NL-OMON22624
- Lead Sponsor
- Maxima Medical Center.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 184
Inclusion Criteria
1.Premenopausal woman aged ≥ 18 years;
2.Patients who report one of the endometriosis related pain symptoms dysmenorrhoea, pelvic pain or dyspareunia;
Exclusion Criteria
1.Women with signs of deep endometriosis (by physical examination, ultrasound or MRI);
2.Not able or willing to provide written informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is: effectiveness of surgical treatment compared to treatment with medication, defined as: <br /><br>-Successful pain reduction (- 30% reduction of pain on visual analog scale [VAS]) after 6 months;<br />
- Secondary Outcome Measures
Name Time Method The secondary outcomes include:<br /><br>-Succesful pain reduction after 12 and 18 months;<br /><br>- Quality of life: measured by the EuroQoL-5D, SF36v and EHP30 questionnaires and this will be used to calculate QALY and productivity loss;<br /><br>- Affective symptoms; measured by the GAD-7 and PHQ-9 questionnaires.<br>-Costs effectiveness: health care costs, patients and family costs and productivity costs measured from a societal perspective using internet questionnaires based on the iMCQ and iPCQ. <br>-Recurrence rate: recurrence of either pain symptoms (measured on the VAS) and the endometrioma itself (measured with ultrasound)<br /><br>-Need of adjuvant medication (analgesics and/or hormones) after surgery, measured with a medication journal;<br /><br>-Ovarian reserve: measured by blood test (AMH levels) and ultrasound (AFC).<br /><br>-Adjuvant surgery: rate of adjuvant surgery 6 months after treatment with medication for endometrioma.<br>