Seraccholi 2003.
Methods | Randomised controlled single centre (Italy) trial. Number of women randomised: N = 62. Number of withdrawals: not clear. Power calculation not reported and unclear if intention to treat analysis. Source of funding not reported. |
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Participants | Inclusion criteria: women with symptomatic fibroid, with mobile uterus and vaginal accessibility with uterus size between 16 to 20 weeks clinically and volume between 380 mL and 680 mL ultrasonographically. Exclusion criteria: women with pelvic pathology as prolapse, pelvic floor relaxation, SI, adnexal mass; women with medical conditions requiring monitoring as diabetes, IHD; women who had therapy with GnRHa, danazol or progestational agents in last 6 months; women who had undergone surgery requiring longitudinal laparotomy; women with any contraindication to operative laparoscopy. |
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Interventions | Treatment group: triptorelin depot 11.25 mg starting in mid luteal phase 3 months before surgery, N = 31. Control group: no therapy, N = 31. |
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Outcomes |
Preoperative Pretreatment: uterine volume and weight, haemoglobin, uterine bleeding, pelvic pain, urinary urgency. Operative Time of operation from skin incision and pneumoperitoneum to closure. Postoperative
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Notes | Age: Treatment group 47.6 ± 3.5 years Control group 48.4 ± 4.6 years |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Patients were assigned at a ratio 1:1 by random selection” – method of randomisation not specified. |
Allocation concealment (selection bias) | Unclear risk | No details were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Women were randomised to injection or no treatment. No details on personnel blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details regarding outcome assessment were provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear whether all participants were included in analysis. |
Selective reporting (reporting bias) | High risk | The study authors only reported adverse events and changes in uterine volume/weight in the intervention group before surgery ‐ no comparison was made with control so this outcome was not relevant to the review. Introduction mentions evaluating “operating time, surgical complications, conversion to laparotomy, blood loss, hospital stay, and costs”. Results report all of these except costs. |
Other bias | Low risk | Groups appear comparable at baseline. |