Re-intervention and patient satisfaction rates following office radiofrequency endometrial ablation: a comparative retrospective study of 408 cases

Abstract

This retrospective study assessed the efficacy and long-term satisfaction of radiofrequency endometrial ablation outside the context of clinical trials in 408 women, and compared the outcome between office-setting (211, 52%) and day-case procedures under general anaesthetics (197, 48%). The Kaplan Meir time-to-event analysis showed that the cumulative number of women undergoing surgical re-intervention was 32 with a probability of 9.4% (95% CI: 6.3 − 12.5%) at 2–years, and 45 with a probability of 14.5% (95% CI: 10.3 − 18.2%) at 5–years. There was no statistically significant difference in the re-intervention rate between office and day-case groups (HR = 0.7, 95% CI: 0.68 − 3.1, p = .3). The satisfaction rate, measured by Visual Analogue Scale, was not statistically different (p = .5) between office (109; 80.7%) and day-case (96; 82.8%) groups. This study showed lower surgical re-intervention rate than previously reported in observational studies, and high rates of long-term women satisfaction. The outcomes were similar in office and day-case settings.

Impact statement

• What is already known on this subject? Previous studies have shown the safety and effectiveness of radiofrequency endometrial ablation for treating heavy periods. However, studies investigating it, outside clinical trials, either included a small sample size, a short-term follow-up, poor reporting so that it is impossible to judge whether some women underwent re-intervention in another centre, failed to discriminate in analysis between second-generation techniques, or assessed only short-term satisfaction.

• What do the results of this study add? This is the largest series reported from a single centre and the first study reporting long-term satisfaction in women, outside clinical trials. Surgical re-intervention was used as the primary outcome measure which is an objective measure rather than the change in the monthly flow which is rather subjective. More importantly, the study records the similarity, in the outcome and women’s satisfaction rate, between office and day-case procedures under general anaesthetics.

• What are the implications of these findings for clinical practice and/or further research? Endometrial ablation service is widely implemented in office-setting in the UK. We hope the result of this study encourages implementation on a larger scale in office across centres in the world with its multiple advantages both to women and service alike.

Keywords:

• Endometrial ablation
• heavy menstrual bleeding
• hysterectomy
• dysmenorrhoea
• radiofrequency endometrial ablation

Ethical approval

Not available since this study is retrospective presenting anonymous data collected from hospital database. Consent for publication Not available since this study is retrospective presenting anonymous data collected from hospital database. The project was considered as "service evaluation"; therefore, ethics approval was not obtained. Service evaluation does not require ethical approval in the UK (University College of London (UCL) Research Ethics Committee, 2018; NHS Health Research Authority (HRA), 2020).

Disclosure statement

None of the authors has received any compensation for this research project. Hologic has not contributed in any capacity to this project or to the manuscript. The last author (AE) received honoraria for lecturing from Hologic.

Author contributions

AG: Data analysis and interpretation, statistical analysis, wrote the first draft of the manuscript, revised, and approved the final version.

SG: Study concept, data collection, data analysis and interpretation, revised and approved the final version of the manuscript.

LR: Data collection, data analysis and interpretation, revised and approved the final version of the manuscript.

AE: Study concept, supervised the work, data analysis and interpretation, revised and approved the final version of the manuscript.