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Ahmed Hashem Abdellah MD, Abdel Aziz Ezz-Eldin Tammam MD, Ahmed Mowafy Ibrahim

Msc and Sayed Ahmed Taha MD

Department of obstetrics and gynecology, Qena faculty of medicine, South Valley University, Qena, Egypt

Objectives: To compare the diagnostic accuracy , acceptability , reliability and sensitivity of saline infusion

sonohysterography (SIS) and hysteroscopy for evaluation of intracavitary abnormalities Study design: prospective cross sectional study

Setting: Qena university hospital, Qena, Egypt

Patients: total of 80 women in outpatient gynecology clinic were enrolled in this study

Interventions: Saline infusion sonohysterography (SIS) and diagnostic hysteroscopy were performed

Main Outcome Measure(s): Sensitivity, specificity, and positive and negative predictive values of Saline infusion

sonohysterography (SIS) and diagnostic hysteroscopy to detect intracavitary abnormalities

Result(s): Hysteroscopy results were sensitivity 96.3%, specificity 85.7%, positive predictive value 92.9% and negative

predictive value 92.3%.While for SIS results were 89.3%, specificity 83.3%, positive predictive value 92.6% and negative

predictive value 76.9%

Conclusion(s): Hysteroscopy is superior to SIS in diagnosis of intracavitary abnormalities. However, saline infusion

sonohysterography (SIS) has the advantages of being non-invasive, cheap, affordable, shorter duration and accurate

method for uterine cavity evaluation

Key Words: diagnostic hysteroscopy, saline infusion sonohysterography, SIS, intracavitary abnormalities, congenital

uterine anomalies, submucous fibroid, fibroid polyp, intrauterine adhesions, recurrent pregnancy loss, abnormal

uterine bleeding, infertility

Introduction

Ultrasound imaging of the female reproductive tract was first described in 1972 by Kratochwil et al., and currently represents one of the most common procedures performed by gynecologists. The recent advances in ultrasound technology have promoted transvaginal ultrasound (TVS) as a non-invasive, low-cost alternative to hysteroscopy. Indeed, it provides good visualization of the endometrium, mid-line echo and uterine cavity. The simplicity of the ultrasound examination has led gynecologists to consider TVS as the ‘first step’ procedure in the evaluation of the uterine cavity. However, which is the best method for the evaluation of the uterus is still a matter of debate. Indeed, a single technique that is 100% reliable, accurate, well tolerated and low-cost is still to be identified (1)

Saline infusion sonohysterography (SIS) is a real-time imaging technique for visualization of the endometrium and endometrial cavity. Sterile saline installation into the endometrial cavity with the aid of the two-dimensional B-Mode transvaginal ultrasonography (TVS) is an easy, fast, cheap and well-tolerated technique for diagnosis of uterine cavity pathologies. SIS offers a detailed vision of the uterine cavity compared to the TVS and can prevent the patient from more invasive procedures such as diagnostic hysteroscopy. Additionally, SIS can also be used to evaluate the tubal patency in some instances and to search for retained products of conception(2)

Hysteroscopy has the advantage of directly visualizing the uterine cavity and endometrium, but it cannot comment on

The Diagnostic value of saline infusion sonohysterography and hysteroscopy in the evaluation of uterine Cavity

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myometrial pathology. The choice of diagnostic procedure seems to be determined largely by clinician’s preference. However, acceptability of the procedure by subjects is very important(3)

Materials and methods

This is a prospective cross sectional study in which a total of 80 women in our outpatient gynecology clinic were invited to participate in this study after taking an informed consent with one of the following as a complaint:

1. Abnormal uterine bleeding 2. Repeated pregnancy loss 3. Infertility 4. Abnormalities in uterine cavity detected by

hysterosalpingography (HSG) 5. Patients known to have submucous fibroid

detected by transvaginal ultrasound

Patients were enrolled in this study as they fulfill the following criteria: 1. age ˃20years 2. no pregnancy 3. normal cervical pathology 4. no suspected malignancy

Patients who were not eligible for this study if 1. Previous history of cervical surgery 2. previous difficulties with hysteroscopy 3. No hormonal therapy one month before

surgery

SIS were performed with a 5.0-MHz vaginal probe, a sterile 8-F Foley catheter (length, 30 cm; diameter, 2.7 mm) will be introduced through the cervical orifice until it reached the fundus. The speculum was withdrawn, and the ultrasound probe was reintroduced into the vaginal canal. A 50-mL syringe containing sterile normal saline will then attach to the catheter. Saline instillation and distention of the uterine cavity with the saline was sonographically observed. Generally, approximately 20 mL of saline was used. The measurements of the endometrium was performed at the thickest part from cornu to

cornu in the longitudinal plane in the single endometrial layer. The uterine cavity contours was inspected for irregularities and suspicious intracavitary lesions were recorded. Deformations of the endometrial lining, absence of central hyperechoic line, and the appearance of any structure with or without well-defined margins or variable echogenicity, is considered abnormal.

Hysteroscopy was performed with a rigid microhysteroscope with a 3.5-mm diagnostic sheath under general anesthesia. We will use saline or glycine as the distention medium. A maximum intrauterine pressure of 100 mm Hg was allowed. The cavity was evaluated visually, with both the tubal ostia being noted and the endometrial appearances documented.

The final diagnosis depends on histopathological examination of the specimens. Examinations by the two diagnostic procedures were completed, and the findings were recorded.

Results

In our study a total of 80 women were enrolled. The mean age of the patients was 36±8.88. However, half of the patients were multipara and represent about 50%

Table I: Patients’ characteristics of the study group:

Study group N : 80 (§)

1. Age Range Mean

23y – 53y 36±8.88

2. Parity Nullipara Multipara grandmultipara

20 (25%) 40 (50%) 20 (25%)

The clinical presentation of the study group was abnormal uterine bleeding and repeated pregnancy loss represent the majority of the study group represent 30%, 20% respectively. Morever, patients with abnormalities in uterine cavity detected by HSG and TVS represent the minority of the group 7.5%, 5% respectively.

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In our study the sonohysterographic findings were normal in 30% in the study group. However, septate and bicornuate uterus were detected only in 5% , 3% of the study group respectively. While the Hysteroscopic findings of the study group were normal in 30%. Fibroid polyp and submucous fibroid represented the main findings among the studied group and represented 30%, 12% respectively.

Table III: SIS findings in the study group:

number percent

Normal 26 32%

Fibroid polyp 18 22%

Submucous fibroid 12 15%

Endometrial hyperplasia 8 10%

Endometrial atrophy 2 3% Intrauterine adhesions 8 10%

Septate uterus 4 5%

Bicornuate uterus 2 3%

Total 80 100%

Table IV: Hysteroscopic findings in the study group:

number percent

Normal 24 30%

Fibroid polyp 18 22%

Submucous fibroid 10 12%

Endometrial hyperplasia 6 8%

Endometrial atrophy 4 5%

Intrauterine adhesions 10 13%

Septate uterus 8 10%

Total 80 100%

In our current study there was no clinical significant difference between SIS and hysteroscopy when comparing normal and abnormal intracavitary uterine finding with the histopathological result.

In the current study the overall sensitivity of SIS was 89.3%, specificity 83.3%, positive predictive value 92.6% and negative predictive value 76.9% While the overall sensitivity of hysteroscopy was 96.3%, specificity 85.7%, positive predictive value 92.9% and negative predictive value 92.3%.

Table II: Patients characteristics according to their clinical presentation:

number percent

Abnormal uterine bleeding

24 30%

Repeated pregnancy loss 16 20%

Infertility 20 25%

Abnormalities of uterine cavity detected by HSG

6 7.5%

Patient known to have submucous fibroid detected by TVS

4 5%

Infertility + Abnormalities of uterine cavity detected by HSG

6 7.5%

Abnormal uterine bleeding + Repeated pregnancy loss

4 5%

Total 80 100%

Table V: Correlation between sonohysterographic and Hysteroscopic findings compared with final histopathological results:

SIS N: 80

Hysteroscopy N: 80

Histopathology N: 80

Normal 26 32% 24 30% 24 30%

Fibroid polyp 18 22% 18 22% 16 20%

Submucous fibroid

12 15% 10 12% 10 12%

Endometrial hyperplasia

8 10% 6 8% 8 10%

Endometrial atrophy

2 3% 4 5% 4 5%

Intrauterine adhesions

8 10% 10 13% 10 12%

Septate uterus

4 5% 8 10% 6 8%

Bicornuate uterus

2 3% 0 0% 2 3%

Total 80 80 80

Table VI: Correlation between Sensitivity, Specificity, Positive and negative predictive values of SIS and Hysteroscopy:

SIS Hysteroscopy

Number of true positive 50 52 Number of false positive 4 4

Number of true negative 20 24

Number of false negative 6 2

Sensitivity 89.3 % 96.3%

Specificity 83.3 % 85.7 %

Positive predictive value 92.6 % 92.9 %

Negative predictive value 76.9 % 92.3 %

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In our study, Post-procedure bleeding was the most common complication of SIS represented in 13.75% of cases moreover there was no clinical significance in the occurrence of complications in both SIS and hysteroscopy

Table VII: Correlation between complications of

SIS and Hysteroscopy in the study group:

SIS N:80

Hysteroscopy N:80

Fever 4 5% 3 3.75%

Infection 3 3.75% 2 2.5%

Bleeding 11 13.75% 3 3.75%

Discussion

A variety of tools are used in the diagnosis of endometrial pathology, the most commonly used being transvaginal ultrasound, saline infusion sonohysterography, diagnostic hysteroscopy and office sampling, used individually or in combination. When constructing a diagnostic algorithm, the choice of one test over another will depend primarily on its diagnostic accuracy.(4)

The introduction of intracervical fluid during TVS constitutes one of the most significant advances in ultrasonography during this past decade. Instillation of saline during ultrasound (SIS) enhances and augments the image of the endometrial cavity, as well as provides valuable information about the uterus and adnexa in patients with abnormal bleeding. Saline infusion sonography overcomes the limitations of traditional TVS for evaluating menstrual and postmenopausal bleeding disorders. This information helps to determine whether endometrial biopsy is needed, select the type of surgical procedure, as certain the hysteroscopic expertise required to remove the lesions, and judge the resectability of lesions (5) Diagnostic hysteroscopy has generally been accepted as the gold standard for evaluation of the uterine cavity. It is an invasive procedure, which is associated with discomfort for the patients and sometimes-vasovagal attack. It can

be performed in the office setting or as a day-case procedure. diagnostic hysteroscopy can be performed by a flexible and rigid hysteroscope. The flexible hysteroscope is not only safer, better tolerated, less painful but also gives an excellent view. (6)

The clinical presentation of the patient in our study was mainly abnormal uterine bleeding followed by focal lesion in the uterine cavity , these findings nearly agreed with the findings of Khan et al.; 2011

In our study the overall sensitivity of SIS was 89.3%, specificity 83.3%, positive predictive value 92.6% and negative predictive value 76.9% while the overall sensitivity of hysteroscopy was 96.3%, specificity 85.7%, positive predictive value 92.9% and negative predictive value 92.3%.

These findings were nearly comparable with the findings of Dueholm et al;2000 who reported in their study that The overall sensitivity of SIS 83% specificity 90%, positive predictive value 85% and negative predictive value 89% While the overall sensitivity of hysteroscopy was 84%, specificity 88%, positive predictive value 80% and negative predictive value 91%.

On the other hand , our result were contrary with the findings of Khan et al.; 2011 who reported in their study 100% sensitivity , 67% specificity , 98% positive predictive value and 100% negative predictive value for SIS , while results for hysteroscopy were 98% sensitivity , 67% specificity , 98% positive predictive value and 67% negative predictive value . No major complications were reported in our study, the main finding was slight bleeding after SIS and improved within few hours and this agreed with Rudra et al;2009

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