Online at International Journal of Current Innovation Research Vol. 4, Issue, 1(A), pp , January, 2018

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1 ISSN: Available Online at International Journal of Current Innovation Research Vol. 4, Issue, 1(A), pp , January, 2018 Research Article International Journal of Current Innovation Research DOI: /IJCIR COMPARITIVE STUDY ON SALINE INFUSION SONOGRAPHY VS. CONVENTIONAL ULTRASOUND IN EVALUATION OF ENDOMETRIAL PATHOLOGY IN PATIENTS WITH ABNORMAL UTERINE BLEEDING Byasdev Mishra., Vinita Singh*., Mahija Sahu and Snehil Sinha Department of Obs and Gyn Add, AIIMS, Raipur, Tatibandh, G.E. Road, Raipur ARTICLE INFO Article History: Received 18 th October, 2017 Received in revised form 10 th November, 2017 Accepted 06 th December, 2017 Published online 28 th January, 2018 Key words: [SIS (Saline infusion sonography), TAS ( Transabdominal Sonography ), TVS (Transvaginal Sonography), SCHS(Saline contrast Hysterosonography), SHG (Sonohysterography),HC (Hysteroscopy), D&C (Dilatation and Curettage), AUB(Abnormal uterine bleeding). ABSTRACT Objective: To determine the accuracy of conventional sonography (TAS/TVS) and saline infusion sonohysterography (SIS) in the evaluation of endometrial pathology and to compare the diagnostic accuracy after hysterectomy. Methods: Prospective comparative study of TAS/ TVS and SIS in the evaluation of endometrial pathology who are being subjected to hysterectomy.then to compare the result with histopathology report Result: : 100 patients were included in the study % were between age group of years. Menorrhagia was the commonest symptom (55.3%) and most common finding was normal endometrium (40%) followed by intramural myoma and adenomyosis (23%). In comparison to surgical histopathology, TVS has 96% specificity and 98.9%negativee predictive value for detection of submucous myoma and nearly equal value for endometrial polyp, endometrial hyperplasia & atrophic endometrium but sensitivity and positive predictive value is less, 66%and 40% respectively for submucous myoma. In comparison to surgical histopathology, SIS has 95.6% sensitivity for detection of intramural myoma & adenomysis. It has nearly 96% specificity, and negative predictive value for detection of submucous myoma, endometrial polyp endometrial hyperplasia, and atrophic endometrium Conclusion: SIS is a simple, low cost still highly sensitive and specific technique to detect intrauterine pathology when TVS findings are inconclusive, and it can obviate the need of office hysteroscopy. Copyright 2018 Byasdev Mishra et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. INTRODUCTION Abnormal uterine bleeding is a major gynecological problem accounting for 33% of outpatient referrals including 69% of referrals in perimenopausal and postmenopausal age group. 1-3 The causes may vary from simple dysfunctional uterine bleeding without any organic cause to the endometrial cancer. The cases of AUB usually need thorough investigation to rule out organic causes especially at perimenopausal and postmenopausal age when the risk of endometrial carcinoma is 10% to 15%. 4-6 Uterine cavity evaluation is a basic step in the investigation of abnormal uterine bleeding. 7 Hysteroscopy is known as the gold standard procedure for uterine cavity assessment, it enables diagnosis and treatment of intrauterine pathology in the same outpatient setting. 8 Evaluation of the endometrium by transvaginal ultrasonography is currently the imaging method of choice in the diagnostic workup for abnormal uterine bleeding Although diagnostic hysteroscopy with guided biopsy may still be considered the method of gold standard in uterine cavity assessment, the diagnostic power of saline infusion sonography (SIS) is comparable to that of diagnostic hysteroscopy. 12 To evaluate the endometrium more adequately, saline solution infusion sonohysterography was described by Parsons and Lenz JJ 13 using the endovaginal probe. Sonohysterography gives even greater detail because there is liquid contrast between the endometrial surfaces and hence polyps and submucous fibroids can be distinguished from diffuse lesions with sonohysterography, the technique can help to identify those patients who would benefit from hysteroscopy and a directed biopsy. Fluid instillation into the endometrial cavity is a procedure rarely associated with infections and complication. It is minimally painful requiring no analgesia while enhancing the ability to make a diagnosis in patients with abnormal uterine bleeding. In this series, a prospective study has been conducted comparing two dimensional transvaginal imaging, saline solution infusion sonohysterography, and endometrial biopsies with surgical histopathology. The purpose of this study is to evaluate the role of saline solution infusion sonohysterography as a screening and diagnostic procedure in clinical practice for patients with abnormal uterinee bleeding. MATERIALS AND METHODS The prospective study on "Saline infusion sonography vs. conventional ultrasound in evaluation of endometrial pathology" was carried out in the Department of Obstetrics and Gynecology, SCB Medical College & Hospital, Cuttack from Sept 2010 to Sept 2012 after getting clearance from institutional *Corresponding author: Vinita Singh Department of Obs and Gyn Add AIIMS, Raipur, Tatibandh, G.E. Road, Raipur

2 ethical committee. 150 cases of abnormal uterine bleeding were selected for this study. pathology of all these cases were studied by TVS, SIS and by D & C. Out of total 150 cases, 100 underwent hysterectomy and the rest were advised appropriate medical treatment. The TVS, SIS and D & C findings of these 100 cases were correlated with the histopathology of the hysterectomized specimen. The surgical histopathology has been considered as the gold standard for diagnosis. The transvaginal sonography findings, the saline infusion sonohysterography findings and the D & C findings have been compared with the surgical histopathology. All the cases were subjected to ultrasonography in the late proliferative phase of the menstrual cycle before putting up the patient for endometrial biopsy in the secretory phase. The ultrasonographic examination were performed by the use of Seimens Sonoline Adara machine equipped with a vaginal transducer in the department of SCB Medical College Cuttack. This transducer has a scanning sector of degree & a frequency of MHz Initially the patients were evaluated with an abdominal transducer to measure the uterus and evaluate any potential pathologic conditions outside the focal length of the vaginal transducer. The patients were then asked to empty their bladder and transvaginal ultrasonography was performed with patients in dorsal position. The transducer was covered by a condom and ultrasound scan gel applied over the transducer. The transducer was introduced into the posterior vaginal fornix and the uterus was scanned longitudinally and transversely, the endometrial thickness was measured at the thickest part in the longitudinal plane by means of electronic caliper built in the ultrasonography machine. Postmenopausal women with an endometrium > 5 mm and pre and peri menopausal women with an thickened endometrium. (The 8mm endometrial thickness was based on the work of Flescher et al, 14. who showed that an endometrial thickness of upto 8 mm in the late proliferative phase occurred in normal patients). Submucous fibroids and polyps appeared as focal areas of thickened endometrium. The intramural myomas were seen as hypoechoic or echogenic masses within the myometrium. In few of the cases, the endometrium could not be well defined and thickness could not be measured regardless of the menstrual state of the patient. endometrium measuring 5-8 mm was seen in many cases. Next, a speculum was placed in the vagina. A sterile preparation of the cervix was done with povidone iodine. A 6F or 8F pediatric foley s catheter was inserted through the cervical os into the uterus. Prior to this a small amount of saline was instilled into the foley s catheter and the outlet was closed in order to remove air. Next, a small amount of saline (1.5cc -3 cc) was injected to inflate the foley s balloon to secure the catheter into position in the cervical canal. The speculum was removed and the vaginal probe was reinserted posterior to the catheter. Under direct ultrasonographic visualization and with use of a 20 ml. Syringe, sterile saline solution 3 to 5 ml was injected to distend the endometrial cavity until the endometrial cavity was clearly seen. Following these investigation, of the 150 cases, 100 were selected for hysterectomy after appropriate pre operative preparation and the rest were given medical treatment. The surgical specimens were preserved in 10% formalin saline and sent for histopathological examination and reports were collected. There was one case of cervical stenosis and two cases of dilated os where insertion and bulb retention failed.] RESULTS Table -1 describes the various type of abnormal uterine bleeding with which the patients presented and were investigated. Menorrhagia was the chief presenting symptom in majority of the cases (55.3%). Postmenopausal bleeding was the complaint in 13.3% of the cases. Oligomenorrhoea Polymenorrhoea Post Menopausal Bleeding Metrorragia Menorrhagia Table 1 Distribution of cases according to presenting symptom 8% 4.60% 18.60% 13.30% 55.30% 0.00% 20.00% 40.00% 60.00% Percentage Table-2 shows maximum number of cases were with normal endometrium (without any associated pathology) found in 41% of cases with TVS which was confirmed to be 39% of cases in surgical histopatholgy. Least number of cases were sub-mucous myoma both in TVS (5%) and surgical histopathology (3%). endometriu hyperplasia Polyp Submucous myoma Intramural myoma& endometriu Table 2 Transvaginal ultrasonographic findings 0% 10% 20% 30% 40% 50% Histopathology (%) Observed TVS finding (%) Table 3 SIS detects highest number of cases (39%) with normal endometrium and least number of case (5%) with sub-mucous myoma. Histopathology also confirms (40%) with normal endometrium and least number of cases (3%) with sub-mucous myoma. Table 4 shows maximum number of cases were normal endometrium (without any associated pathology) found in 41% of cases with TVS, which was confirmed to be 39% of cases in surgical histopathology. Least number of cases were submucous myoma both in TVS (5%) and surgical histopathology (3%). SIS detects highest number of cases (39%) with normal endometrium and least number of cases (5%) with sub-mucous myoma. Histopathology also conforms (40%) with normal endometrium and least number of cases (3%) with sub-mucous myoma. 997

3 endometrium hyperplasia (>5 Polyp Submucous myoma Intramural myoma& endometrium Table 3 saline infusion sonohysterography findings Endomertrial Polyp Submucous Myoma 0% 10% 20% 30% 40% 50% Intramural Table-4 Confirmed After Surgical Histopathology (%) Observed SIS Findings (%) confirmed finding after surgical histopathology Percentage Table 6 comparative Analysis of Sis with Surgical Histopathology Observation DISCUSSION Surgical HP Study SIS Sensitivity Specificity PPV NPV Endometrium % 96.6% 94.8% 95% Submucous Myoma % 97% 50% 98.9% Intramural Myoma & adenomyosis % 98.7% 95.6% 98.7% Polyp % 95% 69% 93% Hyperplasia % 95.8% 63.6% 96% Endometrium % 93% 40% 94.4% Apart from hormonal disbalance, intrauterine abnormalities are the leading cause of AUB; more than 40% of the referred women with AUB are reported to have intrauterine abnormalities. 15 Transvaginal sonography (TVS) plays an important role as the initial modality for evaluation of AUB 3,16,17 but its ability for screening the lesions within the endometrial cavity is limited. The finding of a thickened central endometrial complex seen on TVS is often non-specific and may be caused by an endometrial polyp, submucosal fibroids, endometrial hyperplasia, carcinoma, or cystic atrophy. Focal lesions are underdiagnosed by TVS because of limitations of the double-layer thickness evaluation Endometrium 0%10%20%30%40%50% Table-5 highlights that in comparision to surgical histopathology, TVS has 96% specificity and 98.9% negative predictive value for detection of submucous myoma and nearly equal value for endometrial polyp, endometrial hyperplasia & atrophic endometrium but sensitivity and positive predictive value is less. Table 5 Comparative analysis of tvs with surgical histopthology study observation surgical hp report tvs sensitivity specificity ppv endometrium % 90% 85% 91.5% Sub mucous myoma % 96% 40% 98.9% Intramural myoma & adenomyosis % 98.7% 95.4% 97.4% Polyp % 92.9% 5o% 89.7% Hyperplasia % 94.4% 58.3% 96.5% Endometrium % 93.4% 22.2% 92.3% Table 6 shows that in comparison to surgical histopathology, SIS has 95.6% sensitivity for detection of intramural myoma & adenomyosis & nearly 96% specificity and negative predictive value for detection of submucous myoma, endometrial polyp endometrial hyperplasia, atrophic endometrium. But it is less sensitive and has less positive predictivee value for these. However it has more sensitivity and positive predictive value compared to TVS in detecting the endometrial (submucous myoma, polyp) and also intramural pathology. npv 998 Figure Legend 1 Pedunculated Polyp Figure Legend 2 Submucous Fibroid Saline infusion sonohysterography is a simple technique in which the endometrial cavity is distended with a contrast media and it permits single layer evaluation of the endometrial lining and hence enhances the uterine cavity visualization for any focal or global lesion. The commonest indication for sonohysterography is abnormal uterine bleeding, complaints of which are very common in the premenopausal age group. The investigative protocol still starts with a blind dilatation and curettage in most of the casess and the result of which is most often a normal endometrium. With the advent of safe, effective and non-invasive procedure like sonohysterography, an

4 accurate diagnosis of the cause of abnormal uterine bleeding can be known thus avoiding the unnecessary invasive procedure of dilatation and curettage in many of the patients. Salineinfusion sonography improves the characterization of endometrial thickening and the detection and description of endometrial lesions with a sensitivity and specificity comparable with hysteroscopy When comparing salineinfusionsonography endometrial sampling with final outcomes, saline-infusion sonography endometrial sampling provideda diagnosis 89% of the time (95% confidence interval [CI] 82 95%) compared with endometrial biopsy at 52% (95% CI 42 62%). 25 Several studies in recent literature have indicated that SHG can improve the specificity of TVS in differentiating endoluminal masses from more diffuse endometrial thickening. 21,26-29 In our study Menorrhagia was the chief presenting symptom in majority of the cases (55.3%) followed by postmenopausal bleeding which was found in 13.3% of the cases. In our study maximum number of cases had normal endometrium (without any associated pathology) found in 41% of cases with TVS, which was confirmed to be 39% of cases in surgical histopathology. Least number of cases were with sub-mucous myoma both diagnosed by TVS (5%) and surgical histopathology (3%). SIS also detected highest number of cases (39%) with normal endometrium and least number of cases (5%) with sub-mucous myoma. Histopathology also confirmed maximum cases (40%) with normal endometrium and least number of cases (3%) with sub-mucous myoma. In comparison to surgical histopathology, TVS has 96% specificity and 98.9% negative predictive value for detection of sub mucous myoma and nearly equal value for endometrial polyp, endometrial hyperplasia & atrophic endometrium but sensitivity and positive predictive value is less. In comparison to surgical histopathology, in our study SIS has 95.6% sensitivity for detection of intramural myoma & adenomyosis and nearly 96% specificity and negative predictive value for detection of sub mucous myoma, endometrial polyp endometrial hyperplasia, atrophic endometrium. However it has more sensitivity and positive predictive value compared to TVS in detecting the endometrial (sub mucous myoma, polyp) and also intramural pathology. There are other studies similar to our studies which came out with different results which is mentioned henceforth.in a study by Werbrouck E et al pathology like endometrial hyperplasia, polyp, cancer, or intracavitary myomas was diagnosed in 180 patients (49%) of the SIS group. The sensitivity was 77.8% The negative predictive value was 79.1% for SIS. 30 Saline infusion sonohysterography appears to be more valuable than TVS in the diagnosis of intracavitary masses (both polyps and myomas) 31. With a sensitivity of 0.95 and a specificity of 0.88 SIS is an accurate diagnostic tool in the evaluation of the uterine cavity in premenopausal and postmenopausal women. 32 The pooled sensitivity of SIS in the detection of all intrauterine abnormalities was 0.88 (95% confidence interval (CI): ). The pooled specificity was 0.94 (95% CI ). The positive and negative likelihood ratios were (95% CI: ) and 0.15 (95% CI: ), respectively SIS also had a high pooled sensitivity and specificity in the detection of congenital uterine anomalies, 0.85 (95% CI: ) and 1.00 (95% CI ), respectively. 33. Another study emphasized that TVS shows excellent specificity (95.7%) in uterine polyps detection, good sensitivity (85.7%) and specificity (89.2%) in investigating endometrial hyperplasia, 999 and excellent NPV (92.2%) in the diagnosis of submucous myomas. Diagnostic accuracy of TVS for synechiae is not evaluable. SHG demonstrates high specificity (92.8%) in the detection of uterine polyps, and high sensitivity (92.9%) and specificity (96.8%) in the diagnosis of endometrial hyperplasia. In addition it shows high sensitivity (90%), specificity (99%), PPV (92.2%), and NPV (99%) for detection of submucous myomas. Finally, SHG shows high PPV (100%) and NPV (100%) for synechiae assessment. 34. In a different study they found that polypoid lesion was the most common abnormal pathology. LR+ and LR- of TVS, SIS, and HS were 3.13 and 0.15, 9.83 and 0.07, 13.7 and 0.02 respectively in detection of any abnormal pathology, and the AUCs (Area under curve) of TVS, SIS, and HS were 0.804, 0.920, and respectively. When the three procedures were compared with each other separately, HS had the best diagnostic accuracy, and the diagnostic accuracy of HS and SIS was superior to TVS (p(1)=0.000, p(2)=0.000). For the detection of polypoid lesions, HS was the most accurate diagnostic procedure (AUC=0.947), followed by SIS (AUC=0.894) and TVS (AUC=0.778). 35. Results of a study says that SIS showed a sensitivity of 87%, specificity of 100% and PPV of 100% for endometrial hyperplasia, and a sensitivity and NPV of 100% for polypoid lesions. For submucosal myoma SIS showed a sensitivity of 99% with PPV of 96%. Hysteroscopy had a sensitivity, specificity, PPV and NPV of 98%, 83%, 96% and 91%, respectively for overall uterine pathologies. Finally, SIS seems to be superior to TVS, for uterine pathologies, with respect to hysteroscopy as the gold standard. 36. In another study the comparison of the three diagnostic procedures revealed that the diagnostic accuracy of SIS and HSC is superior to conventional TVS. SIS and HSC had identical accuracy for submucosal myomas (PPV and NPV 1.0 for both), while in case of polypoid lesions the accuracy of HSC was higher than of SIS (HSC: PPV 0.8, NPV 1.0; SIS: PPV 0.75; NPV 0.75). 37. SCSH/SIS showed hyperplasia in 19 patients while hysteroscopy diagnosed polyp in 15 cases. A sensitivity of 73.3%, 71.4% and 90.9% were reported for polyp, hyperplasia and submucous myoma respectively whereas the specificity was calculated 96% for polyps, 82.3% for hyperplasia and 90.7% for submucous myoma. 38. On hysteroscopy, % (n = 46) patients were diagnosed with intra cavity abnormalities. SIS showed sensitivity, specificity, PPV, and NPV of 89.1, 100, 100, and 73.7 %, respectively. In comparison, TVS showed sensitivity, specificity, PPV, and NPV of 43.48, 78.57, 86.96, and %, respectively. 39 In another study they found that the overall sensitivity and specificity when correlated with intra-operative hysterectomy findings and HPE were 66%and 88%respectively for TVS and 82%and 95% for SIS respectively. The false positive and false negative rates were more in TVS compared to SIS. 40 Two meta analysis as mentioned below suggested that SIS is an accurate means of evaluating uterine cavity in perimenopausal women with substantial cost savings as it can replace diagnostic hysteroscopy. First pooled analysis for the two dimensional saline contrast sonohysterography sensitivity and specificity in endometrial polyp detection were 0.93 (95% confidence interval [CI]: ) and 0.81 (95% CI: ), respectively, with LR+ of 5.4 (95% CI: ) and LR- of 0.1 (95% CI: ). In the detection of submucosal uterine leiomyoma, values of the pooled analysis were 0.94 (95% CI:

5 ) and 0.81 (95% CI: ) for sensitivity and specificity respectively with LR+ of 4.5 (95% CI: ) and LR- of 0.11 (95% CI: ). Two dimensional saline contrast sonohysterography presented good accuracy in endometrial polyp detection and submucosal uterine leiomyoma with operating area under the SROC 0.96 (±0.02) 41. Second by De Kroon et al 42 in a meta analysis reviewed 16 studies comprising 877 procedures to determine the diagnostic accuracy of SIS in peri menopausal women with AUB and comparing it to hysteroscopy with or without HPE or hysterectomy, found sensitivity of SIS for evaluating the uterine cavity was 0.95 and pooled specificity was 0.88 and the sonographic procedure was successful in 86.5% of the postmenopausal women and 95% of the premenopausal women. CONCLUSION [In a poor resource country like India saline infusion ultrasonography is a safe and readily available modality for non invasively imaging the endometrial cavity. Saline infusion sonohysterography offers a study that can more clearly visualize the endometrium and may potentially eliminate the need for other studies such as hysteroscopy. In the evaluation process, saline infusion sonohysterography may be complementary to D & C and endometrial biopsy but can be done as the initial diagnostic procedure in the premenopausal age group. But D & C is mandatory in a women complaining of postmenopausal bleeding even if TVS shows an atrophic endometrium. We may miss the early stages of malignancy if we leave such patients after doing a TVS and SIS. Thus, from our study we conclude that saline infusion sonohysterography is a better investigating modality than transvaginal ultrasonography and has an important role as a screening and diagnostic procedure in evaluating endometrial pathology in the pre & perimenopausal age group where many of the D & Cs can be avoided if a normal endometrium is detected. 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