A Randomised Controlled Trial of Microwave Endometrial Ablation Without Endometrial Preparation in the Outpatient Setting: Patient Acceptability, Treatment Outcome, and Costs

Abstract

The authors present the results of a randomized, controlled trial comparing microwave endometrial ablation (MEA) performed after 1 month of hormonal preparation of the endometrium with MEA performed immediately after menses with no uterine preparation. Study subjects were 210 women with excessive menstrual bleeding who were willing to undergo MEA under local anesthesia. Thirteen of the 210 patients withdrew from the study after randomization. One hundred of the remaining 197 women were randomized to receive either 200 mg danazol twice a day for 4 to 5 weeks or one injection of 3.6 mg goserelin subcutaneously 5 weeks before the procedure, and 97 were randomized to undergo MEA from day 3 to day 10 of their menstrual cycle without hormonal pretreatment. All patients were analyzed on an intent-to-treat basis, including 3 women in the postmenstrual group who accidentally received drugs for endometrial preparation. Before treatment, patients received a vaginal suppository containing 100 mg Voltarol or 1 g paracetamol and were offered preoperative intravenous sedation with midazolam (2-4 mg maximum). Intraoperative analgesia with intravenous fentanyl (25-50 μg intravenously maximum) was available on request. Clinical, personal, and quality-of-life information was obtained through patient questionnaire completed before the procedure. In addition, questionnaires concerning clinical information and financial matters were completed postoperatively, at 2 weeks or 1 month, at 6 months, and at 12 months after treatment. The costs of each treatment method were evaluated, including treatment preparation, procedure, other drugs, hospitalization, and postoperative clinic and physician visits. In the drug treatment arm, 3 procedures were not completed. Two women experienced severe pain during MEA and were rescheduled for treatment under general anesthesia. The third patient had severe cervical stenosis and a false passage was created during attempted cervical dilation. She declined further treatment. In the postmenses arm, one woman had a vasovagal reaction early in the MEA process and was scheduled to have the procedure under general anesthesia. There were no other perioperative complications. There were no significant differences between treatment groups in reported levels of pain or discomfort associated with MEA. Requirements for intraoperative anesthesia were the same for both groups, but women who received preoperative drug preparation needed less postoperative pain relief. An overnight hospital stay was more common among women who received hormones than among those who did not (20% vs 12%). Two weeks after treatment, 90% of the postmenses group found the procedure totally or generally acceptable compared with 76% of those in the drug treatment group. More patients who had MEA after menses returned to normal activities within 3 days of treatment than did patients who had endometrial preparation (46% vs 28%). In the month before MEA, those who received hormonal preparation were more much likely than the women in the postmenses group to experience hot flushes, nausea, rashes/itch, and weight gain. At 6 and 21 months after treatment, women in each group reported similar levels of satisfaction with their treatment. Quality-of-life scores were also similar. When asked if they would have the procedure again or change to the other method, 5% of those in the postmenses arm would switch treatments compared with 44% of those who had endometrial preparation.