Document Type : Original Article
Shahid Akbarabadi, Clinical Research Development Unit (ShACRDU), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran
School of Public Health, Iran University of Medical Sciences, Tehran, Iran
Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran
Department of Obstetrics and Gynecology, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
Background: Abnormal uterine bleeding (AUB) that is any irregularity in menstrual cycles causes women to refer to clinics. This study aimed to compare the efficacy, safety, and complications of endometrial ablation by the thermal balloon (Cavaterm) method with the hysteroscopy loop resection method in the treatment of AUB.
Materials and Methods: The present study is an open-label, randomized clinical trial that was performed in the two hospitals, Shahid Akbarabadi and Hazrat Rasoul Akram, of Tehran, Iran, from December 2019 to October 2020. Patients were randomly allocated to the two groups of interventions by a simple randomization method. The proportion of amenorrhea (as primary outcome) and consequent hysterectomy and patient satisfaction (as secondary outcomes) was assessed using the Chi-square test and independent t test.
Results: There was no significant difference between the two groups in the baseline characteristics. The percentage of intervention failure was statistically higher in the hysteroscopy group (24%) in comparison with the Cavaterm group [8.2%, P=0.03, relative risk (RR)=1.63, 95% confidence interval (CI): 1.13-2.36]. Mean ± standard deviation of satisfaction based on the Likert score in the Cavaterm group and hysteroscopy group were 4.3 ± 1.21 and 3.7 ± 1.56, respectively, that showed a significant difference (P=0.04). Assessing the procedural complications, the rate of spotting, bloody discharge, and malodor discharge was significantly higher in the Cavaterm group. In contrast, postoperative dysmenorrhea is more common in the hysteroscopy group.
Conclusion: Cavaterm ablation is accompanied by a higher success rate of amenorrhea and patients’ satisfaction than hysteroscopy ablation (registration number: IRCT20220210053986N1).