Wang 2007.
| Methods | Single centre study Participants were randomly allocated to either intervention or control group according to a computer‐generated sequence Allocation using preprinted slips on sealed envelopes that had been prepared before the started of the study with a computer‐generated sequence Information not given about blinding Power calculation: performed No losses to follow up and all patients were analysed in the group in which they were allocated Funding from the Medical Research Project, Chang Gung Memorial Hospital |
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| Participants | Setting: Chang Gung Memorial Hospital, Taiwan Inclusion criteria: 60 women who had clinical diagnosis of symptomatic leiomyoma (at least an intramural myoma that measured 5cm or more). Diagnosis of leiomyomata was made by pelvic examination and ultrasound scanning in all patients Exclusion criteria: patients with intrauterine lesions were excluded n = 60 Age: mean age of women in the intervention group was 38.1 years (SD = 6.8) and of the control group was 35.8 years (SD =6.1) Ethnicity: not described Mean fibroid size: 7.6 cm (SD = 2.2) in the treatment group and 7.5cm (SD = 1.9) in the control group |
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| Interventions | Treatment arm (n = 30): oxytocin (10 u/mL/amp) in 1000 ml normal saline and run at a rate of 120 mL/h. The administration of oxytocin was started after the anaesthesia was completed. Intravenous oxytocin was stopped immediately after the end of the surgery Control arm (n = 30): normal saline without oxytocin run at a rate of 120 mL/h All patients had bowel preparation the morning of surgery and intravenous cephalosporin prophylaxis was given just before surgery commenced Type of operation: laparoscopy |
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| Outcomes | Number of fibroids removed, operation time, blood loss, hospital day (days), blood transfusion, and complications | |
| Notes | Authors contacted Fibroid size and number removed were similar in both groups |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomly allocated to either intervention or control group according to a computer‐generated sequence |
| Allocation concealment (selection bias) | Low risk | Adequate (allocation using preprinted slips on sealed envelopes that had been prepared before the start of the study with a computer‐generated sequence) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 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 | Low risk | Normal saline without oxytocin was administered to control group as placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information not given on blinding |