Comparison of two protocols for the management of asymptomatic postmenopausal women with adnexal tumours – a randomised controlled trial of RMI/RCOG vs Simple Rules

Abstract

Background:Adnexal tumours are frequently diagnosed in asymptomatic postmenopausal women due to more liberal use of modern high-resolution imaging. This study's objective was to determine if there would be a difference in the intervention rates when using the Simple Rules Management Protocol (SRMP) as compared to the Risk of Malignancy Index in the Royal College of Obstetricians and Gynaecologists guideline (RMI/RCOG).Methods:This was a prospective randomised controlled trial with the participants and the researchers non-blinded, and the surgeons and pathologists blinded. We recruited pain-free postmenopausal women who were diagnosed with an adnexal tumour on ultrasound scan. Women were randomised to either of the two protocols, which then determined if they were offered conservative or surgical management. An intention-to-treat analysis was performed. The primary outcome measure was rate of surgical interventions for ovarian cysts up to 12 months after randomisation. The secondary outcome measures were the number of staging surgical procedures, surgical complications and number of delayed diagnoses of ovarian cancer.Results:A total of 148 women were randomised over 39 months with 73 in the RMI/RCOG arm and 75 in the SRMP arm with outcome data for 136 at 12 months. The two groups were balanced in terms of age, length of time since menopause and use of hormone replacement therapy. There were 18 out of 68 (28.1%) women in the RMI/RCOG arm who had surgery vs 7 out of 68 (10.3%) women in the SRMP arm (P=0.015, χ2-test). The difference in these proportions was 16.2% (95% confidence interval (CI): 3.4–28.9%) and the relative risk was 2.57 (95% CI: 1.15–5.76). There were no significant differences in the number of staging surgical procedures and the surgical complications between the two groups and there were no delayed diagnoses of ovarian cancer at 12 months.Conclusions:Surgical intervention rates in asymptomatic postmenopausal women with an ultrasound diagnosis of adnexal tumours are significantly lower when the novel SRMP protocol is used for triaging compared to the standard RMI/RCOG protocol without an increase in delayed malignant diagnoses.

Clinical Utility of Risk Models to Refer Patients with Adnexal Masses to Specialized Oncology Care: Multicenter External Validation Using Decision Curve Analysis

“…The clinical impact of using ADNEX or SRRisks to select women with adnexal masses for referral to oncological care could further be assessed by a formal cost-effectiveness analysis or in clinical trials, for example, in a randomized controlled trial comparing RMI or ROMA with ADNEX or SRRisks as a basis for referring women with adnexal masses to oncological care. The authors of a recently published randomized controlled trial comparing the original IOTA Simple Rules with RMI for the management of asymptomatic postmenopausal patients concluded that applying the Simple Rules lead to lower surgical intervention rates for asymptomatic women, without an increase in delayed malignant diagnoses (43).…”

Accuracy in Referrals to Gynecologic Oncologists Based on Clinical Presentation for Ovarian Mass

“…The International Ovarian Tumor Analysis Group (IOTA) proposed "Simple Rules (SR)," an objective classification system used for triaging ovarian masses. A total of ten ultrasonographic features are classified as malignant, benign, or indeterminate characteristics [14]. SR does not rely on tumor markers and has fewer surgical interventions with no decrease in diagnosing ovarian malignancies compared to the Risk of Malignancy Index (RMI) [14].…”

“…A total of ten ultrasonographic features are classified as malignant, benign, or indeterminate characteristics [14]. SR does not rely on tumor markers and has fewer surgical interventions with no decrease in diagnosing ovarian malignancies compared to the Risk of Malignancy Index (RMI) [14]. SR is considered the best tool used to assess adnexal masses prior to surgery [11].…”

“…SR is considered the best tool used to assess adnexal masses prior to surgery [11]. SR has been widely validated in Europe but has received limited acceptance in the United States and Canada [14]. Therefore, a newly published article establishes a design for risk stratification of ovarian masses incorporating a pattern-based approach used in both North America and Europe called the Ovarian-Adnexal Reporting and Data System (O-RADS).…”

Simple Adnexal Cysts: SRU Consensus Conference Update on Follow-up and Reporting

“…Table E4 (online) summarizes studies evaluating the risk of malignancy for simple cysts in nonsurgical cohorts (or populations where only some underwent surgery), including screening trials. While all studies are relatively small, five studies had no proven cancers for an incidence of cancer of 0% (patient sample size of 29-116) (29,(59)(60)(61)(62). Four studies had a risk of 0.03%-1% (patient sample size of 138-2217) (6,(63)(64)(65).…”