Deep infiltrating endometriosis Urological and Genital Diseases Endometriosis
Conditions
Interventions
Women with deep endometriosis will be invited to take part. Women with deep endometriosis will be referred by their GP to specialist endometriosis centres and will be invited to take part in DIAMOND b
Sponsors
NHS Grampian
University of Aberdeen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18–49 years old seeking treatment for pain 2. Laparoscopically confirmed deep endometriosis +/- radiological imaging 3. Suitable for either medical or surgical management 4. Able and willing to give informed consent to participate and to participate in study procedures
Exclusion criteria
Exclusion criteria: 1. Unfit for laparoscopic surgery 2. Have used or currently using GnRH analogues without satisfactory relief of pain symptoms 3. Previous bilateral oophorectomy 4. Previous surgery for deep endometriosis 5. Planning to conceive in the next 18 months 6. Confirmed bowel stenosis 7. Hydronephrosis or hydroureter caused by ureteric stenosis 8. Endometrioma >5 cm in diameter 9. Women with preference for medical treatment or surgical treatment 10. Current pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcome: Endometriosis-associated pain measured using the pain domain of the condition-specific Endometriosis Health Profile-30 (EHP-30) at 18 months post-randomisation Primary economic outcome: Incremental cost per quality-adjusted life-year (QALY) gained from a health service perspective, measured using self-completed questionnaires and case note reviews at 18 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcomes measured using self-completed questionnaires at 3, 12, 18 months post-randomisation, unless stated otherwise: 1. Satisfaction with treatment measured on a six-point scale from ‘totally satisfied’ to ‘totally dissatisfied’ 2. Endometriosis-associated pain measured using the pain domain of EHP-30 3. Generic and condition-specific quality of life measured using EQ-5D and EHP-30 4. Need for further medical treatment and/or gynaecological surgery measured using self-completed questionnaires and case note review at 18 months post-randomisation 5. Serious adverse events and major surgical complications assessed using self-completed questionnaires, site-completed case report forms and case note reviews at 18 months post-randomisation 6. Discontinuation of randomised treatment assessed using self-completed questionnaires and case note review at 18 months post-randomisation 7. Occupational outcomes assessed using the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 8. Sexual health measured using the EHP-30 sexual health module 9. Pregnancy measured using patient self-report and case note review at 18 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed