STUDY OBJECTIVE: To evaluate continuous (CON) compared with cyclic (CYC) administration of combined oral estroprogestins for 6 months after laparoscopic excision of ovarian endometriomas associated with pain. DESIGN: Multicenter, prospective, randomized trial (Canadian Task Force classification I). SETTING:Tertiary care university hospitals. PATIENTS: Fifty-seven women aged 18 to 40 years with ovarian endometriomas associated with moderate to severe pelvic pain who underwent laparoscopic excision of the disease. INTERVENTIONS: Patients were randomized to receive postoperative estroprogestins for 6 months, administered as either a CON or CYC regimen. MEASUREMENTS AND MAIN RESULTS: At 3, 6, 12, and 24 months postoperatively, patients were evaluated for recurrence of endometriomas (defined as cysts >3 cm in greatest diameter) using ultrasonography, for recurrence of pain using a visual analog scale, and for patient satisfaction. After a minimum follow-up of 12 months (mean, 22 months), at intent-to-treat analysis, no endometrioma recurrence was observed in the CON group, whereas there was recurrence in 1 patient (4%) in the CYC group. Pain recurred in 5 and 9 patients, respectively (17% vs 32%; p = .23). Compared with pretreatment values, pain scores improved in both groups, with no significant difference between the 2 groups. Most patients in both groups were either satisfied or very satisfied, with no significant difference between treatment groups. However, compared with the CYC group, significantly more patients in the CON group experienced moderate to severe adverse effects, and therapy was discontinued (41% vs 14%; p = .03). CONCLUSIONS: Although both regimens were equally effective insofar as postoperative pain and recurrence of endometrioma, when compared with the CYC regimen, the CON regimen seems to be associated with significantly more adverse effects and discontinuation rates.
RCT Entities:
STUDY OBJECTIVE: To evaluate continuous (CON) compared with cyclic (CYC) administration of combined oral estroprogestins for 6 months after laparoscopic excision of ovarian endometriomas associated with pain. DESIGN: Multicenter, prospective, randomized trial (Canadian Task Force classification I). SETTING: Tertiary care university hospitals. PATIENTS: Fifty-seven women aged 18 to 40 years with ovarian endometriomas associated with moderate to severe pelvic pain who underwent laparoscopic excision of the disease. INTERVENTIONS:Patients were randomized to receive postoperative estroprogestins for 6 months, administered as either a CON or CYC regimen. MEASUREMENTS AND MAIN RESULTS: At 3, 6, 12, and 24 months postoperatively, patients were evaluated for recurrence of endometriomas (defined as cysts >3 cm in greatest diameter) using ultrasonography, for recurrence of pain using a visual analog scale, and for patient satisfaction. After a minimum follow-up of 12 months (mean, 22 months), at intent-to-treat analysis, no endometrioma recurrence was observed in the CON group, whereas there was recurrence in 1 patient (4%) in the CYC group. Pain recurred in 5 and 9 patients, respectively (17% vs 32%; p = .23). Compared with pretreatment values, pain scores improved in both groups, with no significant difference between the 2 groups. Most patients in both groups were either satisfied or very satisfied, with no significant difference between treatment groups. However, compared with the CYC group, significantly more patients in the CON group experienced moderate to severe adverse effects, and therapy was discontinued (41% vs 14%; p = .03). CONCLUSIONS: Although both regimens were equally effective insofar as postoperative pain and recurrence of endometrioma, when compared with the CYC regimen, the CON regimen seems to be associated with significantly more adverse effects and discontinuation rates.
Authors: U Ulrich; O Buchweitz; R Greb; J Keckstein; I von Leffern; P Oppelt; S P Renner; M Sillem; W Stummvoll; R-L De Wilde; K-W Schweppe Journal: Geburtshilfe Frauenheilkd Date: 2014-12 Impact factor: 2.915
Authors: U Ulrich; O Buchweitz; R Greb; J Keckstein; I von Leffern; P Oppelt; S P Renner; M Sillem; W Stummvoll; K-W Schweppe Journal: Geburtshilfe Frauenheilkd Date: 2013-09 Impact factor: 2.915