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

prospective cross sectional study

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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
Hysterosc
opy
N: 80
Histopathol
ogy
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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References
1. Stefano Bettocchi, Luigi Nappi, Attilio Di Spiezio
Sardo, Elena Greco, Maurizio Guida, Filomena
Sorrentino, Giovanni Pontrelli, Michele Quaranta
and Carmine Nappi. : Effectiveness of Hysteroscopy
versus Transvaginal Ultrasound in Diagnosing Intra-
uterine Lesions in Infertile Women.

2. Muzeyyen Gunes, Okyar Erol, Fulya Kayikcioglu ,
Ozlem Ozdegirmenci, Ozlem Secilmis, Ali
Haberal : Comparison of saline infusion sonography
and histological findings in the evaluation of uterine
cavity pathologies.

3. Sefa Kelekci, Erdal Kaya, Murat Alan, Yasemin
Alan, Umit Bilge, and Leyla Mollamahmutoglu:
Comparison of transvaginal sonography, saline
infusion sonography, and office hysteroscopy in
reproductive-aged women with or without abnormal
uterine bleeding Fertility and Sterility (2005),
84,682-686.

4. Krampl E, Bourne T, Solbakken HH, Istre O.
Transvaginal ultrasonography, sonohysterography
and operative hysteroscopy for the evaluation of
abnormal uterine bleeding. Acta Obstet Gynecol
Scand 2001; 80:616 –22.

5. Cullinan JA, Fleischer AC, Kepple DM, Arnold AL.
Sonohysterography; a technique for endometrial
evaluation. Radiographics 1995; 15(3):501–514

6. Gimpelson RJ, Whalen TR. Hysteroscopy as gold
standard for evaluation of abnormal uterine
bleeding. Am J Obstet Gynecol 1995;173:1637–8.

7. Margit Dueholm, Erik Lundorf and Joan Solberg
Sørensen, Reproducibility of evaluation of the
uterus by transvaginal sonography,
hysterosonographic examination, hysteroscopy and
magnetic resonance imaging ;2000

8. Brig S Rudra, Col BS Duggal and Maj D Bharadwaj,
Prospective Study of Saline Infusion Sonography and
Office Hysteroscopy; 2009

9. Faryal Khan, Sadia Jamaat and Dania Al-Jaroudi,
Saline infusion sonohysterography
versushysteroscopy for uterine cavity evaluation;
2011