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,…
ID
Bron
Verkorte titel
Aandoening
- 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
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is: effectiveness of surgical treatment compared to treatment with medication, defined as: <br>
- Successful pain reduction (- 30% reduction of pain on visual analog scale [VAS]) after 6 months;<br>
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Follow-up will take place 6 weeks, 6 months, 12 months and 18 months after (start of the) treatment.
Onderzoeksproduct en/of interventie
Surgical treatment.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Women with signs of deep endometriosis (by physical examination, ultrasound or MRI);
2. Not able or willing to provide written informed consent;
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7447 |
| NTR-old | NTR7689 |
| CCMO | NL67922.015.18 |
| OMON | NL-OMON56253 |