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ID
Source
Brief title
Health condition
- 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
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
This multicenter randomized controlled trial will compare the effectiveness (in terms of successful pain relief and quality of life) and cost-effectiveness of surgical treatment with medical treatment of women with an endometrioma and pain symptoms in order to justify de-implementation of the least cost-effective treatment strategy and further implementation of the most cost-effective strategy. The secondary objectives are to obtain more insight in the recurrence rate of endometrioma after surgical treatment and the ovarian reserve compared to medical treatment.
Study objective
This study aims to reject the null-hypothesis that medical treatment and surgical treatment are equally (cost-)effective. This study aims to test the alternative hypothesis that surgical treatment is the most effective regarding pain relief, improving quality of life and more cost-effectiveness when compared to medical treatment. Potential recurrence of symptoms and decreased ovarian reserve after surgery have to be taken into account to test the hypothesis.
Study design
Follow-up will take place 6 weeks, 6 months, 12 months and 18 months after (start of the) treatment.
Intervention
Surgical treatment.
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
1. Women with signs of deep endometriosis (by physical examination, ultrasound or MRI);
2. Not able or willing to provide written informed consent;
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7447 |
| NTR-old | NTR7689 |
| CCMO | NL67922.015.18 |
| OMON | NL-OMON56253 |