Vercellino 2012.
| Methods | Randomised controlled trial with 80 participants assigned to receive laparoscopic uterine artery clipping and myomectomy, while 86 participants received laparoscopic myomectomy only Study conducted in three centres in Germany from January 2007 to December 2009 Power calculation performed |
|
| Participants | Women between the ages of 18 and 50 years with the diagnosis symptomatic uterine myomas and who had a combined diameter of ≥ 4cm were included into the study. Patients with severe accompanying medical problems, or psychiatric illnesses, which jeopardize participation, or undergoing treatment affecting coagulation and/or hematopoiesis, and patients with suspected malignancy were excluded Ethnicity not described |
|
| Interventions | All patients had laparoscopic myomectomy. The intervention group (Group A) had temporary bilateral clipping of uterine arteries during myomectomy using Yasargil vascular clips and the control group (Group B) received no additional treatment | |
| Outcomes | Outcomes measured were haemoglobin drop, duration of surgery, duration of hospital stay, need for blood transfusion and complications | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random sequence generation by computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Patients allocated to study group temporary clipping of bilateral uterine arteries, Group A) and control (Group B) by means of sealed sequentially numbered brown envelopes containing computer‐generated random numbers |
| 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 | Randomisation was done the day before the surgery and patients were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information |