Ikechebelu 2010.
| Methods | Single study centre. Patients were randomly allocated to either the control group (n = 39), or the intervention group (n = 54). The method of randomisation is not mentioned. Informed consent was obtained in all cases before the procedure Power calculation: Not done Loss to follow up: There was no loss to follow up and all patients were analysed in the group in which they were allocated |
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| Participants | Setting: Tertiary University Teaching hospital in Nigeria Inclusion criteria: Not stated Exclusion criteria: Not stated Mean age: The mean age of patients was 35 years (standard deviation 6.1 years). The mean age was similar in the two groups Ethnicity: Not mentioned Myoma: 83.9% were intramural, 53.8% were subserous and 33.0% were submucous. There was no significant difference with regards to fibroid location |
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| Interventions | Treatment group (tourniquet): Foley catheter was used as an improvised tourniquet applied to the base of the uterus close to the insertion of the uterosacral ligaments. The Fallopian tubes and the ovaries were carefully excluded from the line of the tourniquet to avoid direct compression and necrosis. The tourniquet was released intermittently (at about 30 minutes interval) during the surgery and finally removed after the repair of the uterus Control group (no tourniquet): Myomectomy was performed without the use of any uterine clamp or improvised tourniquet Type of operation: Laparotomy |
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| Outcomes | Blood loss, transfusion rate, and postoperative complications | |
| Notes | Authors not contacted | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | It is unclear how the authors generated the random sequence |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment is not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no incomplete outcome data |
| Selective reporting (reporting bias) | Unclear risk | We do not have access to the study protocol |
| Other bias | Low risk | No other sources of bias identified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The control group receive no treatment, rather than placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome assessors were blinded |