Detection of Benign Intracav

7/28/2019 Detection of Benign Intracav

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Detection of Benign Intracavitary Lesions in Postmenopausal

Women with Abnormal Uterine Bleeding: A Prospective

Comparative Study on Outpatient Hysteroscopy and Blind Biopsy

Stefano Angioni, MD*, Alessandro Loddo, MD, Francesca Milano, MD, Bruno Piras, MD,Luigi Minerba, MD, Gian Benedetto Melis, MDFrom the Division of Gynaecology, Obstetrics and Pathophysiology of Human Reproduction, Department of Surgery, Maternal-Fetal Medicine and

Imaging (Drs. Angioni, Loddo, Milano, Piras, and Melis), and the Department of Hygiene and Public Health (Dr. Minerba), University of Cagliari,

Cagliari, Italy.

ABSTRACT Study Objective: To evaluate the specificity of blind biopsy in detecting benign intracavitary lesions as causes of

postmenopausal bleeding in comparison with directed biopsy via hysteroscopy.

Design: Prospective trial without randomization (Canadian Task Force classification II-1).

Setting: University hospital.

Patients: Three hundred nineteen postmenopausal women with abnormal uterine bleeding.

Interventions: All patients underwent both blind biopsy (Novaks curette) and directed biopsy via hysteroscopy (after at

least a week). All patients with benign intracavitary lesions underwent operative hysteroscopy to enable the removal of

polyps and intracavitary myomas or endometrial resection if required. All patients with pathologic reports of complex

hyperplasia and atypical hyperplasia (20 patients) underwent vaginal hysterectomy with bilateral adnexectomy. All patients

with histology reports of endometrial carcinoma (15 patients) underwent abdominal hysterectomy, bilateral adnexectomy,

and pelvic lymphadenectomy. Histopathologic findings from endometrial specimens obtained after operative hysteroscopy

or uterine specimens obtained after hysterectomy were used as a reference test to establish the prevalence of disease.

Measurements and Main Results: The sensitivity, specificity, accuracy, and positive and negative predictive values ofblind biopsy and hysteroscopy were assessed to distinguish benign intracavitary formations such as polyps, submucous

myomas, and endometrial hyperplasia in postmenopausal patients with abnormal uterine bleeding. The level of agreement

was evaluated by use of the coefficient of concordance . Blind biopsy showed a sensitivity of 11% and a specificity of 93%,

with an accuracy of 59% in detecting endometrial polyps, a sensitivity and specificity of 13% and 100%, respectively, with

an accuracy of 98% for submucous myomas, and values of 25%, 92%, and 80%, respectively, in diagnosing hyperplasia.

On the other hand, hysteroscopy demonstrated a sensitivity of 100% and a specificity of 97%, with an accuracy of 91% in

diagnosing endometrial polyps, a sensitivity and specificity of 100% and 98%, respectively, with an accuracy of 99% for

submucous myomas. The coefficient of concordance (95% CI) was 0.12 for blind biopsy and 0.82 for hysteroscopy,

corresponding, respectively, to slight concordance and almost perfect agreement with final pathologic diagnosis.

Conclusions: Blind biopsy (Novaks curette) demonstrates very low sensitivity and accuracy in the diagnosis of benign

focal intracavitary lesions. Hysteroscopy is confirmed as the gold standard in the assessment of abnormal uterine bleeding

in menopause, permitting the elimination of the false-negative results of blind biopsy through direct visualization of the

uterine cavity and the performance of targeted biopsy in case of doubt. Journal of Minimally Invasive Gynecology (2008)15, 8791 2008 AAGL. All rights reserved.

Keywords: Endometrial biopsy; Abnormal uterine bleeding; Hysteroscopy; Endometrial polyp; Myoma

The authors have no commercial, proprietary, or financial interest in the

products or companies described in this article.

Corresponding author: Stefano Angioni, MD, Division of Gynaecology,

Obstetrics and Pathophysiology of Human Reproduction, Department of

Surgery, Maternal-Fetal Medicine and Imaging, University of Cagliari, via

Ospedale, 09124, Cagliari, Italy

E-mail: [email protected]

Submitted August 7, 2007. Accepted for publication October 13, 2007.

Available at www.sciencedirect.com and www.jmig.org

1553-4650/$ -see front matter 2008 AAGL. All rights reserved.

doi:10.1016/j.jmig.2007.10.014
http://localhost/var/www/apps/conversion/tmp/scratch_6/[email protected]://www.sciencedirect.com/http://www.jmig.org/http://localhost/var/www/apps/conversion/tmp/scratch_6/[email protected]://www.jmig.org/http://www.sciencedirect.com/


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Postmenopausal bleeding represents one of the most com-

mon reasons for which women visit the gynecologist. After

menopause, all uterine bleeding is considered atypical (ab-

normal uterine bleeding [AUB]) and should be rapidly in-

vestigated to exclude endometrial carcinoma, featuring

bleeding in 95% of cases [1,2]. However, frequent causes of

uterine bleeding are represented by atrophy, dysfunctional,benign lesions and only in 7% to 10% of cases, endometrial

carcinoma [3].

Notwithstanding therefore the importance of diagnosing

malignancy, all other causes of bleeding should be detected.

Several methods have been studied to assess AUB, includ-

ing transvaginal ultrasound, outpatient hysteroscopy, hys-

terosonography, office endometrial biopsy, and dilatation

and curettage (D&C). Until fairly recently, the latter was

considered the gold standard for the assessment of AUB.

Many reports have underlined the efficacy of this procedure

in detecting endometrial carcinoma, although not in detect-

ing benign lesions [4]. Transvaginal sonography has facili-tated the evaluation of endometrial thickness and discrimi-

nation between atrophy, hyperplasia, and malignancy,

leading to an increased frequency in diagnosis of endome-

trial polyps and submucous myomas. Interesting trials

aimed at improving this method have been attempted with

hysterosonography, injecting normal saline solution into the

uterine cavity [5]. Indeed, hysteroscopy is an extremely

important tool, enhancing the possibility of correctly diag-

nosing AUB by means of a minimally invasive approach

performed without anesthetics on an outpatient basis. Diag-

nostic hysteroscopy with or without endometrial sampling

represents the new gold standard applied to exclude endo-metrial disease [6]. Hysteroscopy is more effective in as-

sessing abnormal uterine bleeding than blind techniques

such as D&C [7,8]. The use of blind biopsy in diagnosing

benign diseases in postmenopausal women is believed to be

of poor value, although to date no large prospective studies

have been reported in the literature.

Materials and Methods

From January 1992 through October 2004, at the Depart-

ment of Obstetrics and Gynaecology, University of Cagliari,Italy, a series of 319 postmenopausal women with AUB

underwent both blind biopsy (Novaks curette) and diag-

nostic hysteroscopy. A woman was considered postmeno-

pausal if she reported a duration of at least 12 months of

amenorrhea after the age of 45 years, provided that amen-

orrhea had not commenced after medication or disease. All

patients underwent blind biopsy with a Novaks curette at

first evaluation, and a specimen was obtained for his-

topathologic evaluation.

After at least 1 week, all patients underwent diagnostic

hysteroscopy. All hysteroscopies were performed with a

specific procedure for gynecologic diagnosis without gen-eral or local anesthesia. Patients were placed in the lithot-

omy position and after bimanual examination, the cervix

was visualized through a speculum; a rigid hysteroscope (5

mm) was inserted into the uterine cavity without dilating the

cervix or using the tenaculum. The cavity was distended by

supplying carbon dioxide through a Hamou hysteroflator

(Karl Storz, Tuttlingen, Germany) with mean flow of 30 to

35 mL/min and with a pressure limit of 100 mm Hg. During

hysteroscopy, the uterine cavity was described according to

a standard record, which included a description of polyps,

submucous myomas, hyperplasias, endometrial cancer, and

normal/atrophic endometrium.

All patients with benign intracavitary lesions diagnosed

according to histopathologic reports obtained with a No-

vaks curette or diagnosed by outpatient hysteroscopy un-

derwent operative hysteroscopy. The latter procedure en-

abled the removal of polyps and intracavitary myomas and

endometrial resection or ablation if required (in case of

simple hyperplasia). Overall, 181 women underwent hys-teroscopic resection.

Histopathologic study findings from endometrial speci-

mens obtained after operative hysteroscopy were considered

the reference test in establishing the prevalence of specific

conditions. One hundred three patients did not show any

disease at diagnostic hysteroscopy and underwent a re-

peated endometrial biopsy.

All patients with histologic reports of complex hyperpla-

sia and atypical hyperplasia (20 patients) obtained with a

Novaks curette or hysteroscopy (7 patients) underwent

vaginal hysterectomy with bilateral adnexectomy [9]. More-

over, all patients receiving histologic reports of endometrialcarcinoma (15 patients) underwent abdominal hysterec-

tomy, bilateral adnexectomy, and pelvic lymphadenectomy

[10]. In women undergoing hysterectomy, pathologic diag-

nosis used to evaluate the accuracy of both blind biopsy and

hysteroscopy was derived from the uterine specimen.

Statistical Analysis

Students t test was used to compare demographic char-

acteristics. Sensitivity and specificity with a 95% confi-

dence interval, accuracy, and negative and positive predic-

tive values of blind biopsy and hysteroscopy indistinguishing benign intracavitary formations, such as pol-

yps, submucous myomas, and hyperplasias in patients with

AUB were assessed. The 2 and Fishers exact tests were

used to compare sensitivity of the 2 diagnostic methods in

the diagnosis of the 3 benign conditions.

The level of agreement was calculated with the index,

the difference between observed and expected agreement as

a fraction of the maximum difference [11]. The maximum

value of was 1, representing perfect agreement, and the

minimum value was 0, corresponding to an agreement only

because of chance. Values of exceeding 0.81, values

between 0.61 and 0.80, values between 0.41 and 0.60,values between 0.21 and 0.40, values between 0.01 and 0.20

88 Journal of Minimally Invasive Gynecology, Vol 15, No 1, January/February 2008


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represent, respectively, almost perfect, substantial, moder-

ate, fair, and slight agreement [12].

Power calculations performed using data obtained from

published studies [13,14] estimated that only 98 patients per

group were required to observe significant differences in

sensitivity of detecting benign intracavitary lesions (primary

outcome) between the 2 diagnostic procedures, resulting ina 95% power ( 0.05 and 0.05). Data were stored

and analyzed with the use of Statistical Program for Social

Sciences release 12.0 (SPSS Inc., Chicago, IL).

Results

The group-specific demographic characteristics of the

patients are shown in Table 1. The median age of women

was 54 years (range 4688), and median time elapsed since

menopause was 10 years (133). Postmenopausal bleeding

was defined as any vaginal bleeding in a postmenopausalwoman not receiving hormone replacement therapy (HRT)

or as unscheduled bleeding in a postmenopausal woman

receiving HRT. Twenty-five of the women (8%) recruited in

this study were receiving HRT.

Final pathologic reports obtained following hystero-

scopic resection, hysterectomy, or targeted biopsies on hys-

teroscopy are reported in Table 2. We found 133 cases of

polyps (41.7%), 8 myomas (2.5%), 40 simple nonatypical

hyperplasias (12.5%), 17 complex or atypical hyperplasias

(5.3%), 15 endometrial cancers (4.7%), and 106 atrophic

endometrium (33.3%). Diagnostic hysteroscopy and blind

biopsy diagnosis are shown in the same table. In 3 cases, ahistologic diagnosis of normal endometrium was found after

hysteroscopic resection whereas diagnostic hysteroscopy

gave a diagnosis of hyperplasia. In 77 women (24.0%),

blind endometrial biopsy provided insufficient tissue for

pathologic assessment. Reports diagnosed 28 cases of pol-

yps (8.7%), 1 myoma (0.3%), 34 hyperplasias (10.6%), 15

endometrial cancers (4.7%), and 164 results of normal en-

dometrium (51.4%).

With outpatient hysteroscopy, a diagnosis was made for

all patients. We thus diagnosed 131 cases of polyps (41%),

10 myomas (3.1%), 60 hyperplasias (18.8%), 15 endome-

trial cancers (4.7%), and 103 findings of normal endome-trium (32.2%).

The results of the statistical analysis for blind biopsy

procedures are shown in Table 3. We found an accuracy of

59%, a sensitivity of 11%, a specificity of 93%, and a

positive predictive value (PPV) of 54% and a negative

predictive value (NPV) of 59% in detecting endometrial

polyps. We found an accuracy of 98%, a sensitivity of 13%,

a specificity of 100%, and a PPV of 100% and NPV of 98%

for submucous myomas. We found an accuracy of 80%, a

sensitivity of 25%, specificity of 92%, and a PPV of 41%

and NPV of 85% in diagnosing hyperplasia.

In Table 4, we showed that hysteroscopy demonstratessensitivity, specificity, PPV, and NPV of 89%, 93%, 90%, T

able

1

Group-specificdemographiccharacteristicso

fthepatients

Patientswithpolyps

Patientswithhyperplasia

Patientswithsubmucous

myomas

Patientswithendometrial

cancer

Pa

tientswithnormal/

atrophicendometrium

Age(years

SD)[95%

CI]

56.3

7.4

[58.961.7

]

57.1

7.9

[54.359.8

]

54.3

3.0

6[51.756.8]

65.0

1

7.4

*[55.664.5

]

59

.9

7.7

[58.561.3

]

Ageatmenopause(years

SD)[95%

CI]

51.6

4.1

[50.852.3

]

50.7

3.6

[49.451.9

]

50.6

5.2

[46.254.9]

50.8

5.7

[47.354.2

]

50

.4

4.6

[49.551.2

]

Timeelapsesincemenopause(years

SD)

[95%

CI]

8.7

8.0

1[7.210.1

]

7.7

6.6

[5.410.0

]

5.5

5.7

[3.710.2]

14.2

8.4

*[9.119.3

]

9

.7

8.3

[8.111.2

]

Parity

(

SD)[95%

CI]

2.6

7

1.4

[2.42.9

]

2.8

7

1.74[2.33.5

]

3.8

5

2.5

4[1.75.9]

2.8

1

1.4

[1.93.6

]

2.95

2.1

3[2.53.3

]

HRTtherapy(%)

8.8

0

12.5

7.6

4.8

*

p.0

1endometrialcancerversuspolyps,hyperplasia,myomas,andnormal/atrophicendo

metrium.

89Angioni et al. Benign Intracavitary Lesions in Women with AUB


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and 92%, respectively, in diagnosing endometrial polyps,

with an accuracy of 91%. Hysteroscopy has sensitivity,

specificity, PPV, and NPV of 100%, 99%, 80%, and 100%,

respectively, for submucous myomas, with an accuracy of

99%. The worst result is in estimating hyperplasia, with

values of 74%, 93%, 70%, and 94%, respectively, and an

accuracy of 90%.

The 2 comparison between sensitivities of blind biopsy

and hysteroscopy in the diagnosis of polyps and hyperplasia

were 159.53 (p .001) and 27.51 (p .001). Fishers exact

test used to compare sensitivity in diagnosing myomas was

statistically significant (p .001).

The coefficients of concordance (95% CI) were 0.12

(CI: 0.050.18) for blind biopsy and 0.82 (CI: 0.770.87)

for hysteroscopy corresponding, respectively, to slight con-

cordance and almost perfect agreement with final pathology

diagnosis. values were both statistically significant (z

3.9 for blind biopsy and z 22.8 for hysteroscopy), as well

as the difference between the 2 independent values of (z

16.28).

Discussion

An endometrial sampling procedure represents the gold

standard to be applied in diagnostic evaluation of all women

presenting with AUB. The gynecologist has a variety of

tools at his/her disposal for this examination. Endometrial

biopsy and D&C are endometrial sampling procedures. The

development of equipment and techniques for office-basedendometrial biopsy challenged the need for hospital-per-

formed diagnostic D&C requiring anesthesia. Office endo-

metrial biopsy offers a number of advantages over D&C. It

can be performed with little or no cervical dilation, and

anesthesia is generally not required. Moreover, the cost is

approximately one-tenth that of a hospital D&C. Two meta-

analyses have clearly emphasized the satisfactory sensitivity

and specificity of endometrial biopsy in the diagnosis of

endometrial cancer in women with AUB [15,16]. However,

all sampling devices perform better when pathologic studyis global rather than focal. Curettage followed by blind

extraction with Randall polyp forceps improves the rate of

detection of polyps over curettage alone [17].

The aim of our study was to evaluate the sensitivity and

level of agreement of blind biopsy in detecting benign

diseases in more than 300 postmenopausal women with

AUB. Results obtained revealed how 67% of women with

postmenopausal bleeding had a pathologic endometrium.

Blind biopsy revealed an exceedingly low sensitivity and

accuracy in the diagnosis of benign intracavitary lesions and

only a slight concordance with final diagnosis. In particular,

blind biopsy revealed an extremely high number of false-negative results, frequently proving to be of scarce diagnos-

tic value because of the paucity of the sample. On the

contrary hysteroscopy showed a high sensitivity, corre-

sponding almost completely with final diagnosis. Hysteros-

copy was confirmed as the gold standard in the assessment

of AUB in menopause. This procedure facilitated elimina-

tion of false-negative results obtained at blind biopsy, al-

lowing a direct visualization of the uterine cavity and per-

forming of targeted biopsy in case of doubt. Hysteroscopy

provides for direct visualization of the endometrial cavity,

thereby allowing targeted biopsy or excision of lesions

identified during the procedure. However, application ofthis procedure requires greater skills and is more costly and

invasive than most other methods used in endometrial as-

sessment. Multiple studies have shown that hysteroscopy

may enable detection of focal lesions of the endometrial

lining missed by D&C alone [18,19]. Therefore, for women

at risk for endometrial hyperplasia and endometrial cancer,

both procedures or at least targeted biopsy should be per-

formed [20,21]. Moreover, in spite of the low risk of cancer

presented by an endometrial polyp, accurate diagnosis can

be provided only by means of biopsy. Nevertheless, several

atypical features of polyps are readily visible at hysteros-

copy, at times enhancing detection of malignant polyps[22,23]. Saline solution infusion sonography has recently

Table 4

Hysteroscopy statistical results in the diagnosis of benign pathol-

ogy

Hysteroscopy Polyps Myomas Hyperplasias

Sensitivity, % (95% CI) 89 (8293) 100 (68100) 74 (6284)

Specificity, % (95% CI) 93 (8896) 99 (98100) 93 (8995)

Accuracy, % 91 99 90PPV, % 90 80 70

NPV, % 92 100 94

NPV negative predictive value; PPV positive predictive value.

Table 2

Comparison between final histopathology reports and the diagno-

sis obtained with blind biopsies and hysteroscopy

Blind biopsy

(Novak)

No. (%)

Hysteroscopy

No. (%)

Histopathology

No. (%)

Endometrial polyps 28 (8.7) 131 (41.1) 133 (41.7)Hyperplasias 34 (10.7) 60 (18.8) 57 (17.8)

Submucous myomas 1 (0.3) 10 (3.1) 8 (2.5)

Endometrial cancers 15 (4.7) 15 (4.7) 15 (4.7)

Normal endometrium 164 (51.4) 103 (32.3) 106 (33.3)

Not diagnostic 77 (24) 0 0

Table 3

Blind biopsy statistical results in the diagnosis of benign pathol-

ogies

Blind biopsy (Novak) Polyps Myomas Hyperplasias

Sensitivity, % (95% CI) 11 (719) 13 (247) 25 (1637)

Specificity, % (95% CI) 93 (8896) 100 (98100) 92 (8794)

Accuracy, % 59 98 80

PPV, % 54 100 41

NPV, % 59 98 85

NPV negative predicative value; PPV positive predictive value.

90 Journal of Minimally Invasive Gynecology, Vol 15, No 1, January/February 2008


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displayed a diagnostic efficacy equivalent to hysteroscopy

in detecting polyps and intrauterine myomas, although its

use in diagnosing endometrial hyperplasia and cancer in

postmenopausal women with AUB is not recommended,

because the latter should be submitted to histologic confir-

mation [24].

Our prospective study clearly demonstrates that focalendometrial abnormalities are frequent causes of AUB in

postmenopausal women, underlining the inappropriateness

of blind biopsy as a diagnostic approach. The routine use of

blind biopsy should be abandoned in women with post-

menopausal AUB. After transvaginal ultrasonography these

patients should be studied by means of diagnostic hysteros-

copy, with targeted oriented biopsy performed if needed.

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91Angioni et al. Benign Intracavitary Lesions in Women with AUB

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Detection of Benign Intracav