Shaw 2001.
| Methods | Location: UK and Republic of Ireland
No. of centres: 7 Recruitment period: not stated |
|
| Participants | Inclusion criteria: 18‐50 year old women referred for symptom management or infertility Exclusion criteria: cervical intraepithelial neoplasia (CIN) No. randomised: 48 No. analysed: 40 | |
| Interventions | Pre‐operative goserelin versus no treatment Gr A (n=21 ): goserelin 3.6 mg SC monthly for 3 months pre‐operatively Gr B (n=27 ): no medical therapy | |
| Outcomes | Change in endometrioma size, recurrence, pregnancy | |
| Notes | Power calculation: yes Funding: Astra Zeneca, Macclesfield, UK | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | participants were stratified by endometrioma size and "randomly allocated using computer generated randomization lists" |
| Allocation concealment (selection bias) | Unclear risk | not mentioned |
| Blinding (performance bias and detection bias) All outcomes | High risk | not mentioned, no placebo |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 33%(7) and 41% (11) of patients in Gr A & B withdrew from trial before surgery. Reasons given but are different in each group. 4 withdrawals from goserelin group pre surgery due to serious AE ‐ migraine/headache/hot flushes, groin pain, muscle cramps, pain iliac fossa/sciatica. However all patients are included in outcome evaluation provided there is >1 post baseline measurement of endometrioma, but these numbers are not stated |
| Selective reporting (reporting bias) | Low risk | primary outcome is change in size of endometrioma, range of other outcomes including ease of surgery and pregnancy reported |
| Other bias | Unclear risk | some differences between the groups at baseline in mean endometrioma size. Difficulty in recruiting patients made trial underpowered, with different numbers in each group |