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Operatieve of medicamenteuze behandeling van vrouwen met een endometrioom.


- candidate number30533
- NTR NumberNTR7689
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-dec-2018
- Secondary IDsNL67922.015.18 
- Public TitleOperatieve of medicamenteuze behandeling van vrouwen met een endometrioom.
- Scientific TitleSurgical or Medical treatment of women with Endometrioma.
- ACRONYMSOMA-trial
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedQuality of life, Endometrioma, Pain, Cost-effectiveness , Ovarian reserve, Medical treatment vs Surgical treatment
- Inclusion criteria1. 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 criteria1. Women with signs of deep endometriosis (by physical examination, ultrasound or MRI);
2. Not able or willing to provide written informed consent;
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2018
- planned closingdate1-mei-2023
- Target number of participants184
- InterventionsSurgical treatment.
- Primary outcomeThe 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;
- Quality of life: measured by the EuroQoL-5D, SF36v and EHP30 questionnaires and this will be used to calculate QALY and productivity loss;
- 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.
- Secondary outcomeThe secondary outcomes include:
- Succesful pain reduction after 12 and 18 months;
- 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.
- TimepointsFollow-up will take place 6 weeks, 6 months, 12 months and 18 months after (start of the) treatment.
- Trial web sitewww.zorgevaluatienederland.nl/soma
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs. E. Barneveld, van
- CONTACT for SCIENTIFIC QUERIESDr. J.W.M. Maas
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD24-dec-2018 - 2-jan-2019


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