INTRODUCTION

Ovarian tumors, a heterogeneous group of neoplasms with varying malignancy potential, present a significant diagnostic and therapeutic challenge globally, particularly in resource-constrained settings like Bangladesh [1]. Accurate preoperative risk stratification is essential for optimal patient management, guiding surgical decisions and minimizing unnecessary interventions. The RMI, which integrates serum CA-125 levels, menopausal status, and ultrasound findings, has been widely employed to predict malignancy in ovarian masses [2, 3]. However, the predictive accuracy of RMI can vary across different populations and healthcare contexts, necessitating local validation studies [4, 5]. Recent advancements emphasize the integration of clinico-pathological features with molecular markers to enhance diagnostic precision, highlighting the need for context-specific risk assessment tools [6]. Furthermore, familial risk factors, especially the history of ovarian or breast cancer, significantly influence malignancy risk, underscoring the importance of detailed family history evaluation [7]. In Bangladesh, where access to advanced diagnostic modalities may be limited, and healthcare seeking behavior may be delayed, the RMI remains a potentially valuable tool for triaging patients and guiding surgical decisions. The prevalence of ovarian tumors in this region, coupled with the potential for delayed diagnoses due to socioeconomic factors, cultural beliefs, and healthcare access disparities, further emphasizes the need for efficient and cost-effective diagnostic strategies [8, 9]. Given the prevalence of ovarian tumors and the imperative for efficient diagnostic strategies within the Bangladeshi healthcare landscape, this study aims to evaluate the correlation between preoperative RMI and histopathological findings in a cohort of Bangladeshi patients, thereby contributing to improved clinical decision-making within the local healthcare context.

Metairies and Methods:

A hospital-based cross-sectional study was conducted at the Department of Gynecology & Obstetrics, BMU, Dhaka, between September 2022 and August 2023. The study included 102 female patients diagnosed with ovarian tumors who were scheduled for surgical exploration. Patients with histopathological confirmed non-adnexal masses were excluded. A purposive sampling technique was employed to select participants based on predefined inclusion and exclusion criteria. Preoperative evaluation involved a structured clinical assessment, transabdominal ultrasound, and serum CA125 measurement. The ultrasound score (U) was assigned based on the presence of multiloculated cysts, solid areas, bilaterality, ascites, or intra-abdominal metastases, with a total score of 0 for no abnormality, 1 for the presence of one feature, and 3 for the presence of two or more features. Menopausal status (M) was assigned a score of 1 for premenopausal and 3 for postmenopausal patients. Serum CA125 levels were measured using the IMX (Abbott Laboratories, USA) commercial kit, following standard laboratory protocols. RMI was calculated using the established formula RMI = U × M × CA125, with a cut-off value of 200 considered indicative of malignancy.

Following surgical resection, specimens were preserved in formalin and sent for histopathological examination, which served as the diagnostic gold standard. Data collection was conducted using a structured questionnaire, which recorded demographic, clinical, and laboratory parameters. Ethical approval was obtained from the Institutional Review Board of BMU, and permission was secured from the relevant hospital departments. Written informed consent was obtained from all participants, ensuring voluntary participation without coercion. The purpose, procedures, and potential risks of the study were explained in detail, and participants were assured of confidentiality. A unique identification number was assigned to each patient for sample collection, transport, and reporting to maintain anonymity. Safety protocols were strictly followed during blood collection, and privacy was ensured during physical examinations and interviews. No experimental drugs or placebos were used.

Data analysis was performed using SPSS-26. Categorical variables were expressed as frequencies and percentages, while continuous variables were analyzed using Fisher's Exact Test. RMI were calculated to assess its diagnostic performance. A p-value of <0.002 was considered statistically significant.

Data processing plan:

Results:

The socio-demographic distribution of the study population revealed a predominantly young cohort, with most patients 55.9% aged between 15 and 30 years, and a mean age of 29.77 ± 8.106 years. Symptom presentation indicated that a significant portion of patients 66.7% experienced symptoms for 1–3 months prior to diagnosis, with abdominal pain being the most frequently reported symptom. Tumor characteristics showed serous carcinoma as the most common histological finding 28.4%, and intraoperative findings revealed that unilateral tumor presentation was more prevalent. Ultrasound findings commonly included bilateral lesions and solid areas. Biochemical analysis demonstrated that 45.1% of patients had elevated serum CA-125 levels above 100 IU/ml and based on the RMI, a substantial proportion 40.2% were classified as high risk, indicating that nearly two-thirds of the patients fell into moderate to high-risk categories preoperatively. Postoperative complications were primarily wound infections 63.7% and hemorrhage 36.3%. Among patients who underwent total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH-BSO), 69% had the procedure once, while 31% underwent it twice. A statistically significant association was observed between the type of tumor on histopathology and a family history of ovarian or breast cancer (p = 0.002). Surgical interventions predominantly involved cystectomy 68.6%, with oophorectomy performed in 31.4% of cases.

Table 1: Distribution of respondents by socio-demographic factors

Table 1 shows the age distribution revealed that most patients 55.9% were within the 15–30-year age group, while the remaining 44.1% were aged 31 years or older. The overall mean age was 29.77 years with a standard deviation of ±8.106 years, indicating a relatively young study population with a moderate spread in age.

Table 2: Distribution of the respondents by symptoms related factors

Table 2 demonstrate most of patients 66.7% reported experiencing symptoms for 1–3 months prior to diagnosis, while 18.6% had symptoms for less than one month and 14.7% for more than three months. Abdominal pain was the most frequently reported symptom 27.5%, followed by other non-specific symptoms 29.4%, menstrual irregularities 17.6%, abdominal distension 16.7%, and weight loss 8.8%.

Table 3: Distribution of the respondents by tumor related factors

Table 3 revealed that serous carcinoma was the most common tumor type 28.4%, followed by mucinous cystadenoma 20.6% and endometriotic cysts 16.7%. Benign tumors such as serous cystadenoma accounted for 12.7%, while granulosa cell tumors and mucinous carcinoma were less frequent. Intraoperative findings showed that most tumors were unilateral 57.8%, with 30.4% presenting bilaterally and 11.8% associated with ascites. Ultrasound features commonly included bilateral lesions 26.5%, solid areas 22.5%, and multiloculated cysts 18.6%, while ascites were noted in 2.9% of cases.

Table 4: Distribution of the respondents by biochemical test related factors.

Table 4 explained that 45.1% of patients had elevated serum CA-125 levels above 100 IU/ml, while 32.4% had levels between 35–100 IU/ml, and 22.5% had levels below 35 IU/ml. Based on the calculated RMI, 40.2% of patients were classified as high risk >250, 23.5% as intermediate risk 200–250, and 36.3% as low risk <200, indicating that nearly two-thirds of the patients fell into moderate to high-risk categories preoperatively.

Figure 1: Postoperative complications

Figure 1 confirms among the postoperative complications, wound infection was the most common 63.7%, followed by hemorrhage, which occurred in 36.3% of cases.

Figure 2: Total abdominal hysterectomy

Figure 2 indicates among patients who underwent total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH-BSO), 69% had the procedure once, while 31% underwent it twice.

Table 5: Association between type of tumor on histopathology and family history of ovarian or breast cancer.

* Fisher's Exact Test (f). 8 cells (57.1%) have expected count less than 5.

Table 5 shows that there is a significant association between type of tumor on histopathology and family history of ovarian or breast cancer (p=.002).

Figure 3: Surgical intervention.

Figure 3 shows most patients 68.6% underwent cystectomy, while 31.4% required oophorectomy as part of their surgical management.

Discussion:

The findings of this study highlight the utility of the Risk of Malignancy Index (RMI) in differentiating between benign and malignant ovarian tumors in a resource-constrained setting such as Bangladesh. The high proportion of young patients in the study (mean age: 29.77 years) reflects the socio-demographic characteristics of the study population and aligns with findings from Ahmed et al. (2021) [1], who reported that gynecological cancers in Bangladesh predominantly affect younger women compared to global statistics. The statistically significant association between tumor type and family history of ovarian or breast cancer highlights the importance of incorporating familial risk into the preoperative evaluation. This finding reinforces the need for detailed family history taking in clinical practice, particularly in populations where genetic predisposition may play a significant role. Studies have consistently demonstrated the association between familial history and ovarian cancer risk [16]. The prevalence of symptoms such as abdominal pain and nonspecific complaints observed in this study is consistent with previous studies emphasizing the nonspecific nature of ovarian tumor presentations, which can lead to delays in diagnosis [9].

Histopathological findings in this study identified serous carcinoma as the most common tumor type, followed by mucinous cystadenoma, mirroring global data on ovarian cancer types [3]. Furthermore, the observation that benign tumors such as serous cystadenoma constituted a substantial proportion aligns with studies highlighting the predominance of benign ovarian neoplasms in younger populations [4]. Furthermore, the observation that benign tumors such as serous cystadenoma constituted a substantial proportion aligns with studies highlighting the predominance of benign ovarian neoplasms in younger populations [4]. Additionally, the study underscores the significant role of imaging features such as solid areas and multiloculated cysts in characterizing tumor malignancy risk, corroborating findings on the diagnostic importance of transvaginal ultrasonography [10]. The biochemical analysis in this study revealed that a significant number of patients exhibited elevated CA-125 levels, with 45.1% surpassing 100 IU/ml. These results agree with Bristow et al. (2004) [2]. who demonstrated the sensitivity of CA-125 in detecting ovarian malignancies, especially when combined with imaging modalities. However, it is important to note that CA-125 levels can be elevated in benign conditions, which highlights the necessity of using multimodal scoring systems like the RMI for accurate diagnosis [11]. The proportion of patients categorized as high-risk (40.2%) using the RMI further supports its robustness as a diagnostic tool in preoperative settings.

A statistically significant association (p = 0.002) between family history of ovarian or breast cancer and histopathological tumor types was identified in this study [6, 7], which emphasizes the importance of genetic predisposition, particularly BRCA1 and BRCA2 mutations, in the development of ovarian cancer. These findings reinforce the need for genetic counseling and risk assessment in patients with a family history of gynecological malignancies. Postoperative complications such as wound infections 63.7% and hemorrhage 36.3% observed in this study align with the findings of Islam et al. (2020) [8], who reported similar challenges in gynecological surgeries in Bangladesh. These findings highlight the importance of perioperative care to minimize complications. The predominance of surgical interventions such as cystectomy 68.6% and oophorectomy 31.4% further aligns with established surgical management protocols for ovarian tumors [12]. The findings of this study are consistent with previous research globally and regionally, reaffirming the utility of the RMI as a reliable, cost-effective tool for risk stratification in preoperative settings. However, variations in imaging interpretation and access to advanced diagnostic tools remain a challenge [13,14]. The application of newer indices such as RMI3 and RMI4, which incorporate tumor size and additional ultrasound features, could potentially enhance diagnostic accuracy [15]. The potential impact of socioeconomic factors on access to care and disease presentation in this population should also be considered [17]. Future studies focusing on integrating genetic testing and advanced imaging modalities could further refine the risk assessment process.

Conclusion:

The study highlights the Risk of Malignancy Index as a reliable tool for preoperative evaluation of ovarian tumors, effectively distinguishing between benign and malignant masses in a resource-limited context like Bangladesh. The significant correlation between RMI scores and histopathological findings validates its role in guiding timely surgical interventions and optimizing patient care. Incorporating advanced diagnostic methods and genetic screening with the RMI could further enhance its precision, ultimately improving early detection, treatment outcomes, and reducing mortality associated with ovarian malignancies.

Declaration of Interest

The authors declare no competing financial interests.

Conflict of Interest:

The authors declare no conflicts of interest related to this study.

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