Uterine resectoscopic myomectomy with and without Microrelin pretreatment: a single-blinded randomized clinical trial.
Study objective: To assess the outcomes of surgery in the group of patients who were submitted to preoperative GnRH agonists in comparison with those who received no medication. The levels of gonadotropin hormones (LH and FSH) and estradiol, which were measured 2 and 12 weeks after treatment, were also compared between two groups.
Patients: A total of 60 patients participated in this clinical trial. Inclusion criteria were: age between 18-50 y (premenopausal women).
Interventions: Sixty patients were assigned randomly to intervention and control group. Intervention group received three doses of monthly intramuscular injections of Microrelin 3.75 mg (a sustained release formulation of triptorelin) before hysteroscopic myomectomy and control group received no medications. Uterine resectoscopic myomectomy was performed in both groups.
Results: Operation characteristics including operation time and amount of absorbed fluid were measured. Level of difficulty and satisfaction from surgeon’s view were assessed based on Visual Analog Scale (VAS). Serum levels of LH, FSH and estradiol were measured at the baseline and after 2 and 12 weeks in both groups. A total of 60 patients participated in this clinical trial. The sizes of myomas were significantly reduced in microrelin group in comparison with control group (33% reduction, p<0.0001). The administration of Microrelin led to significant reduction of estradiol, LH and FSH levels after 12 weeks. However a transient flare-up in the level of estradiol was detected after 2 weeks. The satisfaction level from operation from surgeon’s view was significantly higher (p=0.01) and the level of difficulty was lower in Microrelin group (p=0.049). No significant difference in haemoglobin drop after operation was detected between two groups.
Conclusions: Our study showed that pretreatment with Microrelin before uterine resectoscopic myomectomy could lead to less surgical difficulties and subsequently lower operation time. The amount of haemoglobin (as an indicator of blood loss) was not affected with this intervention. Our study supports the beneficiary influence of GnRH agonists in outcomes of myomectomy.For more information click here