Diagnostic value of saline infusion sonohysterography for detecting endometrium focal leson

Diagnostic value of saline infusion sonohysterography for detecting endometrium focal lesion

Sanam Moradan¹, Sati Nik Darzi², Raheb Ghorbani^3,&

 

¹Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran, ²Semnan University of Medical Sciences, Semnan, Iran, ³Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran

 

 

^&Corresponding author
Raheb Ghorbani, Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran

 

 

 

 

Abnormal uterine bleeding (AUB) is one of the most common disorders in women at the childbearing age. The AUB can cause complications in personal and social life [1]. The AUB term refers to any change and irregularity of menstrual cycle and covers all changes in the duration, number, and amount of bleeding [2,3]. Although it has been estimated that more than 30% of referrals to the women health centers are related to the AUB; it is worth to notice that some patients may not be referred [1]. This fact might explain why the prevalence of the AUB in different studies had a range from 10 to 52% [4-6]. The AUB has numerous disadvantages on patients' health-related quality of life (HRQL) such as loosing concentration on the jobs [3], treatment costs [7] and iron storage deficiency [8]. The HRQL, as defined by the World Health Organization (complete personal, social, psychological and spiritual health), is frequently used regarding bleeding disorders, particularly AUB [9-12]. In the UK, the AUB has been considered as a cause of physical and psychosocial health problems and total quality of life as a result of the medical and paramedical effects [13] that highlights the need to assess the AUB early and with tools that are reliable and valid. There are different diagnostic tools to evaluate the endometrial focal lesions. The main and the most common tools are transvaginal sonography, sonohystrography and hysteroscopy. This variety of tools makes the first choice difficult and controversial. Transvaginal Sonography (TVS) is the first measure to diagnose abnormal endometrium proliferation in the AUB condition in the pre-and post-menopausal ages [14,15], while, Saline Infusion Sonohystrography (SIS) seems to be superior to TVS, for uterine pathologies [16]. The SIS is usually carried out by entering the sterile saline into uterine cavity [14] and should be done on specific days (days 3 to 7 of the menstrual cycle and the best is day 6^th that is close to the end of bleeding period), when the Endometrial Cavity is thin [17,18]. Diagnostic hysteroscopy with endometrial biopsy is gold standard [19,20], allows inside vision of the uterus to diagnose and treat the causes of abnormal bleeding [20]. The study by Kelelci et al. in Turkey, reported the sensitivity and specificity of the SIS (81.3 and 100%, respectively), to be higher than TVS (56.3 and 72%, respectively) and it is almost the same as hysteroscopy (87 and 100%, respectively) [21]. The high sensitivity (91.9%) and specificity (98.8%), positive predictive value (PPV) (97.1%) and negative predictive value (NPV) (96.5%) of the SIS for the AUB, in the study by Makris et al. endorsed the reliability of this method [15]. This study aimed to investigate the sensitivity, specificity, positive and negative predictive values of the SIS.

 

 

Participants: in this cross-sectional study, 100 patients referred to Amir Al-momenin Hospital in Semnan, from March 2014 to February 2016, were selected according to the inclusion criteria. All of the participants were married, age ≥18 years, with a history of the AUB, stable vital signs plus suspected to the focal lesion in their uterine cavity (especially polyps, submucosal myomas, irregular endometrium, and adhesion), or endometrial thickness ≥12 mm in the non-menopause stage and at or above 5 mm in the post-menopause stage. The AUB after menopause was considered as any bleeding without hormonal therapy. The participants did not have any history of diabetes, hypertension, thyroid disease, pelvic inflammatory disease and uterine surgeries. They did not have any evidence of pregnancy.

 

Measurements: the first author as an experienced gynecologist did the TVS, the SIS, the hysteroscopy, focal lesion resection and endometrial biopsy for all participants. The TVS and SIS were carried out between 3^rdand 7^th days of the menstrual cycle and in menopause women at the earliest possible date. A transvaginal transducer (15M.Hertz probe) was used to measure endometrial thickness, size and position of myomas and polyps. To implement the SIS, a sterile speculum was passed and the cervix was disinfected with Betadine solution. A flexible Foley catheter (children feeding tube catheters, length: 15 cm, diameter: 2 mm) with inflatable balloon (produced by Supa, Tehran, Iran) was inserted via the cervical canal until the uterine was found. At the proper position of the catheter, 10 ml of sterile saline solution (0.9%) were injected by 50 ml volume syringe into the uterine cavity slowly and the injection was continued to obtain optimal view of the endometrial cavity. This procedure was performed without using any local anesthesia or prophylactic antibiotic. All participants in the proliferative phase of menstrual cycle underwent diagnostic operative hysteroscopy, which contains a telescope (2.7-4 mm in diameter) inserted into the endometrium cavity under a general anesthesia. The hysteroscopy was performed under cervical dilatation, prophylactic antibiotic and two misoprostol vaginal tablets (six hours before operation). Focal lesion resection and endometrium biopsy (as the gold standard tests) were performed during the hysteroscopy.

 

Ethical considerations: the study was approved by the human ethics committee of Semnan University of Medical Sciences. All participants were informed about the study before signing a consent form, and we were reassured to the patient that his information would be confidential.

 

Statistical analysis: we analyzed data by SPSS 23.0. The SIS sensitivity, specificity, positive and negative predictive value and accuracy (the ability of a specific tool to represent the proportion of true positive and true negative results in the selected population) were calculated.

 

 

Mean ±SD age of women was 41.2±11.3 years. Table 1 shows other characteristics information of women. The mean±SD endometrial thickness in SIS was 9.2±3.2 mm. Polyp was the most common focal lesion found by the SIS (40.0%) and the hysteroscopy (47.0%). However, Myoma was detected only in eight percent of the participants using the SIS and in nine percent of the participants through the hysteroscopy. Table 2 shows the agreement between the findings of the three different methods and the pathological findings. Table 3 demonstrates the figures of the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the three different diagnostic approaches for the uterine focal lesions (polyps, myomas), polyps or myomas. SIS showed a sensitivity of 79.6%, 75.0% and 60.0% for focal lesions, polyps and submucous myomas respectively whereas the specificity was reported 89.1% for focal lesions, 87.5% for polyps and 97.8% for submucous myomas.

 

 

The present study confirmed that the SIS has good sensitivity and very good specificity, PPV and NPV to detect the endometrial focal lesion However, its sensitivity, specificity, PPV and NPV were less than those of the hysteroscopy and better than the TVS. Reviewing the literature concerned about the capability of these methods to detect endometrial focal lesions was controversial. There are studies that reported sometimes higher and sometimes lower scores for these features in the SIS. The finding of the present study is more promising than the findings reported by Yildizhan et al. for the specificity of the SIS. Yildizhan et al. indicated satisfactory specificity for the SIS to find the endometrial lesion [22]. Aslam et al. with similar aims reached to 92.9% and 89.7% for the sensitivity and specificity respectively for the SIS [23]. Again their findings were close to the findings of the present study. They proved excellent and very good scores for the SIS to detect endometrial focal lesions that is better than the score of the present study. In 2000, Dijkhuizen et al. provided excellent sensitivity (100%) and very good specificity (85%) for the SIS to detect the uterine lesions. The researchers concluded that the diagnostic accuracy of the SIS was higher than those of the TVS and the combination of the TVS and reserving saline infusion sonohystrography in patients with increased thickness (above 5 mm), or patients that endometrium could not be seen adequately by the TVS [24]. Even the findings reported by the Alborzi et al. were not supported by the findings of the present study. Alborzi et al. indicated the SIS had excellent records for the sensitivity (94.1%), specificity (95%), NPV (90%) and PPV (96%) [25]. These excellent records for the SIS to detect focal lesion in the uterus was repeated in the other [26,27].

 

On the other hand, there are studies that presented results in line with the results of the present study such as Ogutcuoglu et al. Ogutcuoglu et al. examined the sensitivity, specificity, PPV and NPV of the SIS in 100 clients to detect endometrial focal lesion. Their findings were approximately similar to the findings of the present study [28]. Gunes et al. evaluated 83 patients with the AUB and the results showed the SIS was a very accurate method to detect polyps. They reported very good figures for the sensitivity, specificity, PPV and NPV of the SIS [29], which is approximately in line with the results of the present study. While the present study indicated that the SIS has less sensitivity and specificity than those of the hysteroscopy, the results of Soares et al. study (2000) found out the same diagnostic accuracy as the gold standard for the hysteroscopy and the SIS to detect the polyps, and endometrial hyperplasia [30]. The Soares results were repeated in the findings reported by Epstein et al. and Chawla et al. study (2014) that showed the SIS and hysteroscopy have very good sensitivity to detect endometrial polyps and endometrial abnormalities [31,32]. De kroon et al. in their study have also indicated that the SIS is a valid and reliable diagnostic alternative to hysteroscopy and diagnostic hysteroscopy can be limited to inconclusive or failed SIS [33]. The greatest challenge of the SIS in the present study was the inability to perform direct biopsy and special tools, like NiGo device has been produced which is easy to perform and it provides sufficient tissue sample. Another limitation of this study was the use of children feeding tube catheters, rather than SIS catheters (Elliptoshpere).

 

 

Findings show that, SIS probably is a proper method for detecting endometrial focal lesion including polyps and myomas. Future studies may help to define further advantages of this procedure.

 

 

The authors declare no competing interests.

 

 

Sanam Moradan conception and design, interpretation, manuscript writing. Sati Nik Darzi, conception and design, data collection. Raheb Ghorbani conception and design, data analysis and interpretation, manuscript writing.

 

 

The authors thank the Semnan University of Medical Sciences, Semnan, Iran (Islamic Republic of) because of financial support. We thank Dr Masoomeh Salmani (Assistant Professor in Speech Therapy) for comments that greatly improved the manuscript.

 

 

Table 1: demographic variables in the study group (n = 100)

Table 2: number of uterine abnormalities diagnosed using SIS, TVS and hysteroscopy in compared with the final diagnosis at pathology

Table 3: comparative diagnostic value of SIS, TVS and hysteroscopy in the diagnosis of focal lesions (polyps or myoma), polyps and myomas in compared with the final diagnosis at pathology

 

 

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