BACKGROUND: Submucous fibroids are common benign tumours responsible for menorrhagia, subfertility and miscarriage. They can be readily removed by hysteroscopic transcervical resection of myoma (TCRM). To facilitate resection, pre-operative GnRH analogues have been suggested, but the value of this treatment is uncertain. Our aim was to assess the value of pre-operative GnRH analogues for the resection of submucous fibroids. METHODS: This was a prospective, double-blind, placebo-controlled, randomized trial. Women found to have submucous fibroids on three-dimensional saline infusion sonohysterography (3D SIS) were randomized to receive GnRH or placebo. Following treatment patients underwent TCRM by a single operator blinded to the group allocation. Women were followed up 6 weeks after their operation to ascertain resolution of symptoms. The primary outcome measure of the study was completeness of fibroid resection. Secondary outcome measures included the duration of the TCRM, the fluid deficit recorded at TCRM, the resolution of symptoms post-operatively and the number of subsequent fibroid related operations. RESULTS:Forty-seven women were randomized to GnRH or placebo. On the basis of intention-to-treat analysis, there was no significant difference in the number of complete fibroid resections between women who received GnRH analogues [14/24, 58.3% (95% CI 38.6-78.1)] and those who received placebo [16/23, 69.6% (50.8-88.4)] (RR 0.84, 95% CI 0.54-1.29; P = 0.43). Similarly there was no significant difference between the groups in any of the secondary outcome measures. CONCLUSIONS: Our study does not support routine administration of GnRH analogues before transcervical resection of fibroid as we did not identify any benefit in such treatment.
RCT Entities:
BACKGROUND: Submucous fibroids are common benign tumours responsible for menorrhagia, subfertility and miscarriage. They can be readily removed by hysteroscopic transcervical resection of myoma (TCRM). To facilitate resection, pre-operative GnRH analogues have been suggested, but the value of this treatment is uncertain. Our aim was to assess the value of pre-operative GnRH analogues for the resection of submucous fibroids. METHODS: This was a prospective, double-blind, placebo-controlled, randomized trial. Women found to have submucous fibroids on three-dimensional saline infusion sonohysterography (3D SIS) were randomized to receive GnRH or placebo. Following treatment patients underwent TCRM by a single operator blinded to the group allocation. Women were followed up 6 weeks after their operation to ascertain resolution of symptoms. The primary outcome measure of the study was completeness of fibroid resection. Secondary outcome measures included the duration of the TCRM, the fluid deficit recorded at TCRM, the resolution of symptoms post-operatively and the number of subsequent fibroid related operations. RESULTS: Forty-seven women were randomized to GnRH or placebo. On the basis of intention-to-treat analysis, there was no significant difference in the number of complete fibroid resections between women who received GnRH analogues [14/24, 58.3% (95% CI 38.6-78.1)] and those who received placebo [16/23, 69.6% (50.8-88.4)] (RR 0.84, 95% CI 0.54-1.29; P = 0.43). Similarly there was no significant difference between the groups in any of the secondary outcome measures. CONCLUSIONS: Our study does not support routine administration of GnRH analogues before transcervical resection of fibroid as we did not identify any benefit in such treatment.
Authors: Alexander Stephan Boosz; Peter Reimer; Matthias Matzko; Thomas Römer; Andreas Müller Journal: Dtsch Arztebl Int Date: 2014-12-22 Impact factor: 5.594
Authors: Min Jin Lee; Bo Seong Yun; Seok Ju Seong; Mi-La Kim; Yong Wook Jung; Mi Kyoung Kim; Hyo Sook Bae; Da Hee Kim; Ji Young Hwang Journal: Obstet Gynecol Sci Date: 2017-01-19