A Multicenter Study Evaluating the Effect of Ulipristal Acetate during Myomectomy.

STUDY OBJECTIVE

To compare surgical experience at myomectomy between patients with myomas pretreated with ulipristal acetate versus no pretreatment.

DESIGN

A prospective, observational, multicenter study of myomectomy procedures by any route (hysteroscopic, laparoscopic, or laparotomy) (Canadian Task Force classification II-2).

SETTING

Five university-affiliated hospitals including tertiary care and community sites.

PATIENTS

Any patient who underwent hysteroscopic, laparotomic, or laparoscopic myomectomy regardless of medical pretreatment.

INTERVENTIONS

Surgeons completed a Web-based questionnaire after each myomectomy procedure. Surgeons evaluated visualization, the myoma-myometrium relationship, extrusion, fluid deficit, blood loss, and overall ease of hysteroscopic myomectomies. For laparotomic/laparoscopic myomectomies, plane delineation, myoma separation, blood loss, and overall ease were assessed. The total surgical experience score was calculated by summing the values for each subscale.

MEASUREMENTS AND MAIN RESULTS

A total of 309 myomectomies were evaluated by 52 surgeons (response rate = 83%) at 5 institutions. Of 140 hysteroscopic myomectomies, 84 (60%) were performed without pretreatment, 29 (21%) after ulipristal acetate pretreatment, and 27 (19%) after pretreatment with gonadotropin-releasing hormone agonist/other. Of 169 laparotomic/laparoscopic myomectomies, 104 (62%) were performed without pretreatment, 46 (27%) after ulipristal acetate, and 19 (11%) after gonadotropin-releasing hormone agonist/other. The mean surgical experience score (±standard deviation) was comparable between the no pretreatment and ulipristal acetate groups for hysteroscopic myomectomies (13.8 ± 2.2 vs 13.3 ± 2.2, p = .35) and laparotomic/laparoscopic myomectomies (12.9 ± 4.1 vs 12.1 ± 4.2, p = .30). Compared with no pretreatment, more laparotomic/laparoscopic myomectomies after ulipristal acetate pretreatment were associated with difficult delineation of surgical planes (22 [47.8%] vs 23 [22.1%], p = .002) and difficult myoma separation (20 [43.5%] vs 21 [20.2%], p = .003). More myomas were described as soft with ulipristal acetate pretreatment (14 [30.4%] vs 17 [16.4%], p = .049). The rates of profuse/abundant endometrium during hysteroscopy were similar between the no pretreatment (21 [25.0%]) and ulipristal acetate (7 [24.1%], p = .93) groups.

CONCLUSION

Despite differences in surgical nuances, the overall myomectomy experience was not negatively affected by ulipristal acetate pretreatment.