Original Article

DIAGNOSTIC ACCURACY OF SALINE HYSTEROSONOGRAPHY IN DETECTING IN PATIENTS WITH POSTMENOPAUSAL BLEEDING

Beenish Yousufa, Hira Ambreenb, Tahira Mariamc , Abdul Raoufd , Ambreen Yaseena, Rabia Aslamb, Muhammad Ahsane aWomen Medical officer, Department of Obstetrics & Gynecology, Government General Hospital, Faisalabad. bConsultant Gynecologist DHQ Hospital, Chiniot. cWomen Medical officer THQ Hospital Chichawatni. dAssistant Professor, Department of Radiology, Faisalabad Medical University, Faisalabad. eMedical Officer, Department of Pediatrics, Government General Hospital, Faisalabad.

ABSTRACT:

BACKGROUND & OBJECTIVE: Saline hysterosonography is a simple and cost-effective method with high sensitivity to detect uterine abnormalities causing postmenopausal bleeding. The objective of this study was to evaluate the diagnostic accuracy of saline hysterosonography in detecting endometrial hyperplasia in women with postmenopausal bleeding by taking histopathology as a gold standard. METHODOLOGY: A hundred and twenty (120) cases were enrolled from the outpatient and inpatient department of obstetrics and gynecology. Proper history and relevant examination of the patient was done. Then preparations were made for the procedure. The patient was counseled and the technique explained to her. Then Foley catheter no 12 was passed in and sonography was done while instilling normal saline through a cervical catheter and scan pictures were frozen and results were given by expert gynecologist of Allied Hospital, Faisalabad. Histopathology specimen was sent to the pathology lab. RESULTS: Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of saline hysterosonography in detecting endometrial hyperplasia was recorded as 96.15%,91,49%,75.76%,98.85%, and 92.5% respectively. CONCLUSION: Saline hysterosonography has high sensitivity to detect uterine hyperplasia. It can be used as a cost effective alternative to hysteroscopy in many units in Pakistan. KEYWORDS: Saline hysterosonography, Endometrial hyperplasia, Postmenopausal bleeding.

doi: https://doi.org/10.37723/jumdc.v11i2.304

How to cite this: Yousuf B, Ambreen H, Mariam T, Raouf A, Yaseen A, Aslam R, Ahsan M. DIAGNOSTIC ACCURACY OF SALINE HYSTEROSONOGRAPHY IN DETECTING ENDOMETRIAL HYPERPLASIA IN PATIENTS WITH POST MENOPAUSAL BLEEDING. jumdc. 2020;11(2):1-8. doi: https://doi.org/10.37723/jumdc.v11i2.304 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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INTRODUCTION: Corresponding Author: Dr. Muhammad Ahsan Postmenopausal bleeding (PMB) occurs in Medical Officer, Govt General Hospital, Faisalabad. approximately 3% of postmenopausal women Email: [email protected] [1]. Abnormal bleeding is the cause behind 33% of all admissions to gynecology center and 69% [2] c a n b e r e p l a c e d b y s a l i n e c o n t r a s t among postmenopausal women . Excessive [10] bleeding occurring outside of regular menstrual sonohysterography (SCSH) . Saline contrast cycle in which two-third of all hysterectomies is s o n o h y s t e r o g r a p h y o r s a l i n e accounted for is characterized as abnormal hysterosonography (SCHS) can be considered [3] as a primary diagnostic method in the detection uterine bleeding . Simple atrophic to [11] endometrial carcinoma in postmenopausal of uterine cavity abnormalities . It seems that women is the reason for abnormal bleeding. The SCSH is a noninvasive, cost-effective, and feasible technique and less painful for patients most common lesions resulting in abnormal [ 1 2 ] uterine bleeding are endometrial polyps, t h a n h y s t e r o s c o p y . S a l i n e uterine fibroids, endometrial hyperplasia [4]. hysterosonography has become a valuable Surgical treatment may be required for them. diagnostic modality in gynecology over the last While medical treatment is required for three decades and is now commonly used for a [2] thorough evaluation of the lesions in the dysfunctional causes . [13, 14] The chance of having endometrial carcinoma for endometrial cavity . patients with PMB is 10–15% [5]. For women The rationale of this study is to introduce a over the age of 40 with abnormal uterine simple and noninvasive investigation tool to bleeding, the clinician's vital task is to exclude detect endometrial abnormalities in patients endometrial carcinoma [6]. The excessive with postmenopausal bleeding and its effect on p r o l i f e ra t i o n o f n o r m a l c e l l s c a n b e clinical administration. The objective of this characterized by the term endometrial cross-sectional (validation) study was to assess hyperplasia. It can further be ordered into three t h e d i a g n o s t i c a c c u r a c y o f s a l i n e types: simple, complex, and atypical. The hysterosonography in detecting endometrial development rate of malignancy is less than 3% hyperplasia in women with postmenopausal for both simple and complex types due to bleeding by taking histopathology as a gold p r e m a l i g n a n t c o n d i t i o n s . I n va r i o u s standard. arrangements, the risk of underlying malignancy has demonstrated to be higher than METHODOLOGY: anticipated. So it is very important to detect it as early as possible to make decisions regarding The study has been approved by the ethical surgery if the patient is high risk or follow up in review committee of Faisalabad Medical low-risk cases [7]. In a previous study, the University, Faisalabad. Postmenopausal prevalence of endometrial hyperplasia was bleeding was diagnosed when a woman after 26%[1]. menopause, presented with complaints of per- For the analysis of uterine abnormality leading that may range from spotting to postmenopausal bleeding, an assortment of to a massive pool of blood. Menopause is tools can be utilized. Among these, for the defined as the last menstrual period after a evaluation of abnormalities of the uterine minimum of 1-year and her age cavity, hysteroscopy is considered the gold >50. standard [8]. With saline hysterosonography endometrial In postmenopausal women, transvaginal hyperplasia, typically appear as diffuse sonography (TVS) is an effective screening test t h i c ke n i n g o f t h e e n d o m e t r i u m w i t h for the evaluation of abnormal uterine bleeding endometrial thickness 5mm to 8mm. On caused by endometrial atrophy [9]. But in the histopathology of the biopsy specimen, figure of thickened and inhomogeneous endometrial hyperplasia is characterized by , TVS is presented as low mild to marked increase in several glands of specificity and limited diagnostic tests which different sizes and unpredictable shapes with

2 JUMDC Vol. 11, Issue 2, April-June 2020 YOUSUF B., AMBREEN H., et al. SCSH IN ENDOMETRIAL HYPERPLASIA cystic dilatation, with mild to a marked was recorded and informed consent was taken escalation in gland to stroma ratio and from patients or their guardians to incorporate glandular epithelial cells may or may not have the information in research work. cytologic atypia as defined by loss of polarity, After receiving patients in the outpatient vesicular nuclei, and prominent nucleoli. department or after admission in ward, proper Sensitivity is the proportion of true positives out history and relevant examination of the patient of all those who truly have the endometrial were done. Then preparation was made for the hyperplasia. Specificity is the proportion of true procedure. The patient was counseled and the negatives out of all those who truly don't have technique explained to her. Foley's catheter no the endometrial hyperplasia. Positive predictive 12 was passed in cervix and sonography was value is the proportion of true positives out of all done while instilling normal saline through a t h o s e w h o a r e p o s i t i v e o n s a l i n e cervical catheter and scan pictures were frozen hysterosonography. Negative predictive value and results were given by expert gynecologist of is the proportion of true negatives out of all Allied Hospital, Faisalabad. Regarding t h o s e w h o a r e n e g a t i v e o n s a l i n e histopathology specimen, it was sent to the hysterosonography. True positives (TP) are Pathology laboratory in Faisalabad Medical those individuals who are positive on saline University where results were given by expert h y s t e r o s o n o g r a p h y a s w e l l a s o n pathologist. histopathology. True negatives (TN) are those All the data were analyzed by SPSS version-23. individuals who are negative on saline Quantitative variables like age endometrial hysterosonography as well as histopathology. thickness were presented by the mean and False positives (FP) are those individuals who standard deviation. Frequency and percentage are positive on saline hysterosonography but were presented for qualitative variables like negative on histopathology. False negatives true positives. Sensitivity, specificity, positive (FN) are those individuals who are negative on predictive value, negative predictive value, and saline hysterosonography but positive on diagnostic preciseness were determined by histopathology. building two into two tables by taking It was conducted in the Department of histopathology as the highest level standard. obstetrics and gynecology, Allied Hospital, Faisalabad after 6 months of synopsis approval. RESULTS: Sample size 120 was calculated using sample size calculator for sensitivity and specificity, Age distribution of the patients showed that taking Sensitivity=92%, Specificity=78%, 76.7% (n = 92) were in Group-A i.e. between e x p e c t e d p r e va l e n c e o f e n d o m e t r i a l 50-60 years of age and 23.3 % (n = 28) were in hyperplasia of 26% and confidence level=95%, Group-B i.e. between 61-70 years of age precision for sensitivity = 8%, for specificity = (Table-I). Mean age and endometrial thickness 10%. Sampling was done using non-probability of the patients were calculated. The mean ± SD consecutive sampling. All postmenopausal for age and endometrial thickness was w o m e n w i t h a g e > 5 0 y e a r s h a v i n g calculated as 57.18 ± 4.92 years and 3.99 ± postmenopausal bleeding were included in the 1.54 mm respectively (Table-II). study. The following were excluded: already Sensitivity, specificity, positive predictive value, diagnosed cases of cervical carcinoma, negative predictive value, and diagnostic , and hematomata; patients with accuracy of saline hysterosonography in acute pelvic infection, acute uterine detecting endometrial hyperplasia was hemorrhage, and diagnosed cases of recorded as 96.15%, 91,49%, 75.76%, . 98.85% and 92.5% respectively (Table-III). After taking approval from the hospital ethical Regarding age distribution, Sensitivity, committee, patients presenting in the specificity, positive predictive value, negative gynecological outpatient and inpatient predictive value and diagnostic accuracy of department, fulfilling the inclusion criteria for saline hysterosonography in detecting the study were enrolled. The identity of patients endometrial hyperplasia in group A i.e. between

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50-60 years of age were recorded as 100%, 70 years of age were recorded as 94.4%, 40%, 97.6%, 80%, 100%, and 97.8% respectively, 73.9%, 80% and 75% respectively (Table -IV). while these values for Group-B i.e. between 61-

Table-I: Age Distribution (n=120). Groups Frequency Percent A 50-60 years 92 76.7 B 61-70 years 28 23.3 Total 120 100.0

Table-II: Mean age & endometrial thickness. N Minimum Maximum Mean Std. Deviation Age 120 51 70 57.18 4.922 Endometrial 120 2.00 9.00 3.9958 1.54008 Thickness

Table-III: Diagnostic accuracy of Saline Hysterosonography Endometrial hyperplasia on histopathology Total Yes No Endometrial hyperplasia on Yes 25 8 33 saline hysterosonography No 1 86 87 Total 26 94 120 Sensitivity = 96.15% Specificity = 91.49% PPV = 75.76% NPV = 98.85% Diagnostic accuracy = 92.5%

Table-IV: Diagnostic accuracy of saline hysterosonography in different age groups. Age Endometrial Distribution hyperplasia on histopathology Total Yes No Group-A Endometrial Yes 8 2 10 Sensitivity = 50-60 years hyperplasia on saline No 0 82 82 100% hysterosonography Specificity = 97.6% Total 8 84 92 PPV=80% NPV = 100% DA=97.8% Group-B Endometrial Yes 17 6 23 Sensitivity = 61-70 years hyperplasia on saline No 1 4 5 94.4% hysterosonography Specificity = 40% Total 18 10 28 PPV=73.9% NPV = 80% DA=75%

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DISCUSSION: differentiation of intracavitary, endometrial, and sub-mucosal abnormalities. Saline A common presenting complaint of patients in hysterosonography was abnormal in all cases of gynecology department is postmenopausal endometrial carcinoma in the current study. bleeding. In postmenopausal patients due to There was a good comparison between diffuse endomyometrial border, endometrium is hysteroscopy and saline hysterosonography more difficult to measure. With the addition of where the former was the gold standard. The cutting-edge imaging modalities, the accuracy of hysteroscopy and saline e v a l u a t i o n a n d m a n a g e m e n t o f hysterosonography was almost equal though postmenopausal bleeding are evolving rapidly. saline hysterosonography is less expensive and Transvaginal sonography (TVS) is a first-line better tolerated [18]. Also in our unit, only indoor insightful methodology in the assessment of hysteroscopy is available. Many studies have postmenopausal bleeding; however, it has confirmed that saline hysterosonography is as restricted an incentive in assessment and good as hysteroscopy under general anesthesia differential determination of intra-cavitary at detecting/ excluding focal lesions. unusual pathologies. For women with Hydrosonography is less painful and cost- postmenopausal bleeding, hysteroscopy (HS) effective than hysteroscopy [19]. In many units in and saline hysterosonography are alternative Pakistan, hysteroscopy is not available. Hence diagnostic procedures and are more effective in the latter can be replaced in the local setting by the detection of intra-cavitary abnormal s a l i n e h y s t e r o s o n o g r a p h y. S a l i n e p a t h o l o g i e s t h a n T V S . W h i l e s a l i n e hysterosonography greatly reduces the number hysterosonography is cost-effective and of unnecessary hysteroscopy as it is only noninvasive, diagnostic HS is still generally indicated where focal lesions need further accepted as the gold standard for the evaluation evaluation/removal. of the uterine cavity. It is an invasive procedure, In another study, the sensitivity and specificity which is associated with discomfort for the of saline hysterosonography were 92.9% and patients and sometimes a vasovagal attack 89.7% [20] respectively which is also in [15,16]. agreement with our results. But in another This study was conducted with the purpose to study [8], these results were different i.e. 82% establish the indicative accuracy of saline sensitivity and 95 specificity. Still, two other hysterosonography in postmenopausal studies, [21,22] showed a sensitivity of 71.4% and patients. As patients with immeasurable 89.3 and specificity of 82.3% and 77.3%.In endometrium often harbor cancer so these these studies, overall sensitivities and patients were included in the study. specificities are less than that found in our study In this study, 5 mm cut-off was used. All the specificity is more than sensitivity in the first ladies with abnormal saline hysterosonography two studies whereas sensitivity is more in the had diagnostic or therapeutic procedures. De last study which is in agreement with our study. Kroon et al [17] did a meta-analysis of diagnostic Initial two examinations are directed in women accuracy of SCHS among women reporting with with unusual uterine bleeding of all ages but the abnormal uterine bleeding. Two studies used >5 last study was conducted in women with mm cutoff and one used >6 mm cut-off, all at postmenopausal bleeding. This may be the variance with this study with a cut-off of 5 mm. reason for this difference found in these studies. The sensitivity and specificity in these studies The learning curve of saline hysterosonography were 96/92%, 100/95%, and 89/50% is considered to be very short for those familiar respectively. The present results of 96.15% with gynecological ultrasound. Failure is almost sensitivity and 91.49% specificity are close to always due to cervical stenosis. In the present the pooled result of de Kroon's meta-analysis series, poor cavity distension was found in 95% for sensitivity 88% for specificity [10]. In cases of endometrial cancer and the same was another study, the same results of 95% observed earlier. Distension difficulties in saline sensitivity and 88% specificity were found [6]. hysterosonography raise the suspicion of For the screening of intracavitary pathologies, a carcinoma. The detection rate of Doppler useful procedure is hysterosonography it allows ultrasound is slightly lower than that for saline

JUMDC Vol. 11, Issue 2, April-June 2020 5 YOUSUF B., AMBREEN H., et al. SCSH IN ENDOMETRIAL HYPERPLASIA infusion, whereas the false-positive rate of patients before hysteroscopy because it will Doppler is around five times higher. The clinical protect a considerable number of patients from value of 3D ultrasound is a matter of current unnecessary invasive procedures [28]. debate [17]. We are also of the opinion that saline Chawla I et al showed the sensitivity of 89.1% hysterosonography should be done for all and specificity of 100%. NPV of 73.7% and PPV p a t i e n t s w i t h s u s p e c t e d e n d o m e t r i a l of 100% [23]. Kasidag et al mentioned the hyperplasia. Further studies should also be sensitivity, specificity, PPV, and NPV to be 93%, done at other centers in our local population 53%, 86%, and 71% respectively in the case of regarding the role of saline hysterosonography saline hysterosonography [24]. The pooled in the diagnosis of endometrial lesions including sensitivity of saline hysterosonography in the hyperplasia. detection of intrauterine abnormalities was 0.88. The pooled specificity was 0.94. SCHS CONCLUSION: also had a high pooled sensitivity and specificity in the detection of congenital uterine Saline hysterosonography has high sensitivity anomalies, 0.85 and 1 [95% CI 0.99- 1] to detect uterine hyperplasia. It can be used as respectively [25]. Mathew et al [26] concluded that a cost effective alternative to hysteroscopy in saline infusion sonohysterography is a simple many units in Pakistan. evaluating method with minimal invasiveness and cost which is more accurate than TVS and CONFLICT OF INTEREST: can be done as a screening tool before hysteroscopy. It is now accepted that Saline All authors disclose no conflict of interest. infusion sonohysterography also is a reliable method for evaluation of endometrial lesions G R A N T S U P P O R T & F I N A N C I A L and after saline hysterosonography appropriate DISCLOSURES: None. treatment can be planned [27]. S a l i n e h y s t e r o s o n o g ra p h y c o u l d n o t REFERENCES: differentiate benign from malignant lesions. But saline hysterosonography helps in choosing the 1. Choudry A, Shukr I, Khan S, Hafeez H, patient where operative hysteroscopy is Jamal S, Anwer A. Acceptability and required. Saline infusion sonography (SIS) and a c c u r a c y o f s a l i n e i n f u s i o n 3D-SIS were correspondingly precise in sonohysterography in women with assessing the histological nature, intrauterine postmenopausal bleeding. Journal of degree, and area of intrauterine abnormalities. College of Physicians and Surgeon Pakistan The dependability of 3D-SIS was good: intra- 2010; 20: 571-575. observer and inter-observer agreement were 2. Abdelazim IA, Abdelrazak KM, Elbiaa AA, 0.78 and 0.72. They concluded that three- Al-Kadi M, Yehia AH. Accuracy of dimensional saline infusion sonography is endometrial sampling compared to legitimate and dependable for women conventional dilatation and curettage in suspected of having intrauterine variations women with abnormal uterine bleeding. from the norm (abnormalities). It may have Archives of gynecology and obstetrics. relevant clinical value in addition to 2015;291(5):1121-1126. Doi:10.1007/ conventional saline hysterosonography as the s00404-014-3523-y. endometrial cavity is three dimensional [17]. 3. Kotdawala P, Kotdawala S, Nagar N. In a study published in a local journal, it was Evaluation of endometrium in peri- reported that saline hysterosonography has a menopausal abnormal uterine bleeding. specificity of 96%, the sensitivity of 60%, Journal of mid-life health. 2013;4(1):16- positive predictive value (PPV) 87.8%, negative 21. doi: 10.4103/0976-7800.109628 PMID: predictive value (NPV) 83.3%, and the accuracy 23833528. rate was 87% for endometrial lesions. For TVS, 4. Nieuwenhuis LL, Hermans FJ, de Vaate AM, PPV was 75%. They concluded that saline Leeflang MM, Brölmann HA, Hehenkamp hysterosonography should be performed in WJ, et al. Threedimensional saline

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