A prospective randomized open study comparing goserelin (Zoladex) plus surgery and surgery alone in the management of ovarian endometriomas

Abstract

Objective To determine whether goserelin (Zoladex TM ; AstraZeneca, London, UK), plus surgery offers advantages over surgery alone in the management of ovarian endometriomas. Design Prospective, multicentre, randomized, open‐label, parallel‐group study. Interventions Following preoperative aspiration of endometriomas, they were sized by ultrasound, a diagnosis of endometriosis confirmed by laparoscopy and its severity assessed. Patients were stratified according to endometrioma size and randomly allocated to one of two groups: group 1 (G1; n = 21) received a monthly (every 28 days) subcutaneous injection of goserelin 3.6 mg for 3 months (12 weeks); group 2 (G2; n = 27) received no treatment. At 3 months, the size of endometriomas was reassessed in both groups before definitive excision. Both groups were reassessed at 6 months postsurgery. Main outcome measures Change in size of the largest endometrioma from entry to just prior to excision. Results The mean change in endometrioma size was −2.29 cm in G1 and −1.29 cm in G2. The resulting (adjusted) mean difference of −1.25 cm was statistically significant in favour of G1 ( P = 0.036, 95% CI −2.42 to −0.08 cm). Very difficult surgery was reported in four (22%) patients in G1 and 10 (46%) patients in G2. Mean duration of surgery was 74.2 min in G1 and 86.4 min in G2. There was a trend towards a greater reduction in mean Additive Diameter of Implants (ADI) score at 6 months postsurgery in G1 compared with G2 (−65.9 vs. −56.6). Both groups were comparable in terms of the number of complete excisions of their endometrial cysts at surgery, blood loss at surgery, Revised American Fertility Society (R‐AFS) scores and pelvic symptoms. Goserelin was well tolerated. Conclusions Laparoscopic aspiration of endometriomas followed by a monthly goserelin 3.6 mg depot for 3 months compared with laparoscopic aspiration alone results in significantly smaller endometriomas at 3 months and a trend towards a greater reduction in ADI score.