Leone Maggiore 2011.
| Methods | Randomised controlled trial with 70 participants randomised: 35 participants to Group A (Tachosil group) and 35 participants to Group B (no treatment group) Setting: Italy |
|
| Participants | Patients of reproductive age with intramural uterine fibroids Inclusion criteria: only patients with diagnosis of intramural fibroids via ultrasound where the distance between the deepest part of the fibroid and the endometrium is ≥0.5cm Exclusion criteria: women with >3 fibroids, subserosal or submucosal fibroids, fibroid diameter >10cm, use of hormonal treatments in the 6 months before surgery, previous uterine surgery, any pathology requiring further surgical treatment, BMI ≥ 29, women with contraindications to general anaesthesia, or any women with a psychiatric condition that prevents informed consent Ethinicity not reported |
|
| Interventions | All myomectomies were done laparoscopically Participants of the intervention group were administered fibrin sealant patch called Tachosil i.e. collagen sponge with thrombin and fibrinogen used to stop local bleeding on internal organs (n=35) The control group received no additional treatment (n=35) Time required to apply the Tachosil was measured The median number of Tachosil used on each patient was 1 with a range of 1‐3 |
|
| Outcomes | The outcomes measured included the postoperative complications, volume of blood collected intraoperatively, volume of blood in drainage bag, No. of days with drainage bag and No. of days of hospitalisation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation by a “computer‐generated list” |
| Allocation concealment (selection bias) | Low risk | A statistician with no role in the study assigned the groups into sealed, opaque envelopes in sequential order |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no loss to follow up |
| 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 | Control group had no treatment rather than a placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | A researcher who did not know to which group the patients were randomised, recorded the post‐op complications, volume of blood in the drainage bag, and the no. of days the drainage bag was used |