None listed
Conditions
Interventions
Surgical treatment.
Sponsors
Maxima Medical Center.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Premenopausal woman aged ≥ 18 years; 2. Patients who report one of the endometriosis related pain symptoms dysmenorrhoea, pelvic pain or dyspareunia; 3. Endometrioma ≥ 3 cm (by ultrasound or MRI).
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is: effectiveness of surgical treatment compared to treatment with medication, defined as: -Successful pain reduction (- 30% reduction of pain on visual analog scale [VAS]) after 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include: - Succesful pain reduction after 12 and 18 months; - Quality of life: measured by the EuroQoL-5D, SF36v and EHP30 questionnaires and this will be used to calculate QALY and productivity loss; - Affective symptoms; measured by the GAD-7 and PHQ-9 questionnaires. - 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. - Recurrence rate: recurrence of either pain symptoms (measured on the VAS) and the endometrioma itself (measured with ultrasound) - Need of adjuvant medication (analgesics and/or hormones) after surgery, measured with a medication journal; - Ovarian reserve: measured by blood test (AMH levels) and ultrasound (AFC). - Adjuvant surgery: rate of adjuvant surgery 6 months after treatment with medication for endometrioma. | — |
Contacts
Public ContactEsther van Barneveld
MUMC
Outcome results
None listed