Sclerotherapy versus surgery in endometriomas. Clinical trial

Description

This current randomized clinical trial compares the effectiveness of ethanol sclerotherapy for preserving fertility and recurrences against laparoscopic cystectomy. The recurrence rate was similar between the two groups, with rates of 21.2% (14 of 66) in the surgery group and 19.1% (17 of 89) in the sclerotherapy group (p=0.8). In the subset of women wanting to become pregnant, rates of pregnancy were notably higher in the sclerotherapy group (26 of 40, 65%) than in the surgery group (13 of 26, 50%), and significantly earlier. Mean direct hospital costs were significantly lower in the sclerotherapy group than in the laparoscopic group: 472 versus 2128 euros. Complications were low in both groups (12%), most of which were grade I-II, although in the surgery group 4.1% were grade III. The results are similar by protocol and as treated analyses.

Steps to reproduce

To examine recurrence, the Kaplan-Meier curve was plotted, and the adjustment variables were examined. Hazard ratios were calculated using Cox models. To find an optimal cut-off point of cyst diameter for recurrence, the bootstrap technique was performed with 1000 iterations with sample replacement. In each iteration, the best Youden index was selected from a logistic model with recurrence as the outcome variable and cyst diameter as the explanatory variable. Kaplan–Meier curves and log-rank tests were also used to estimate the incidence of pregnancy. All statistical analyses were carried out using R statistical software version 3.5.0 (2018-04-23

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