Campo 1999.
| Methods | Randomisation according to a computer generated sequence but no description of attempts to conceal allocation and no blinding. Number of women randomised: 60 Number of women analysed: 60 No power calculation reported. No source of funding reported. | |
| Participants | Women aged 25 to 42 years selected for laparoscopic myomectomy between June 1993 and December 1996 at a clinic in Italy. Inclusion criteria: presence of symptomatic subserosal or intramural myomas; presence of uterine myomas as the only plausible explanation for a history of recurrent abortion or infertility. Diagnosis by transvaginal sonography indicated by fibroid symptoms. Exclusion criteria: submucous myomas; myomas > 10 cm in diameter; women with more than 3 myomas > 4 cm in diameter. | |
| Interventions | Rx: Decapeptyl 3.75 mg intramuscularly every 28 days for 3 months before surgery, N = 30. Control: No preoperative treatment before surgery, N = 30. Duration 3 months. | |
| Outcomes | Duration of surgery (minutes) Postoperative complications Blood transfusion rate Duration of hospital stay (days) Fertility rate (number of pregnancies) Blood loss (mL) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “Patients included in the present series were randomized according to a computer‐generated sequence”. |
| Allocation concealment (selection bias) | Unclear risk | No details regarding allocation concealment were provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were not blinded, as they either received immediate surgery or treatment and delayed surgery. It is not stated whether personnel were blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details were provided. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All women were followed‐up for a minimum 6 months. No missing data. |
| Selective reporting (reporting bias) | Low risk | Outcomes of interest were reported. |
| Other bias | Unclear risk | No details provided of baseline variables between groups. |