diagnostic hysteroscopy for direct assessment of the uterine cavity has been a relatively recent acquisition in the armamentarium of the gynecologists . in an outpatient setting , the entire evaluatory workup takes at least two to three visits prior to arriving at a definitive diagnosis and commencement of appropriate therapy . in the current scenario of increasing cost awareness and an ever - increasing litigious environment , a balance has to be achieved between the practice of  blanket  medicine aiming at performance of all investigations possibly contributing to a diagnosis versus a condition appropriate approach . the study presented was undertaken to evaluate the sensitivity and specificity of embx and transvaginal ultrasound tvs for detection of intracavitary uterine lesions compared with results of office hysteroscopy ( oh ) , which were taken as the gold standard . a secondary objective of the study was to evaluate the protocol for assessment of the common problem of aub . appropriate management could thus be instituted at the earliest possible opportunity , minimizing the number of unnecessary investigations as well as the numerical patient visits to the clinic , without compromising the quality of patient care . prospective observational study conducted at the department of gynecology at massachusetts general hospital ( mgh ) between january , 1995 , and september , 1996 . patients attending the gynecology department at mgh with complaints of abnormal uterine bleeding were evaluated for inclusion in the study . the catchment population was from the resident managed gynecology clinic and from practices of two attending physicians with a special interest in reproductive endocrinology . aub was defined as either cyclic excessive bleeding , irregular menstrual cycles , postmenopausal bleeding , and excessive or unscheduled withdrawal bleeding on hormone replacement therapy ( hrt ) . each patient presenting underwent a preliminary assessment by history and clinical examination ; pap smear status was evaluated and updated if indicated . the uterine size was assessed clinically and determined as normal or enlarged . the study protocol aimed at obtaining an outpatient endometrial biopsy ( embx ) usually at the initial presentation , followed by a transvaginal pelvic ultrasound ( tvs ) . other than oh , the other investigations were performed without consideration of the phase of the menstrual cycle ; oh was scheduled in the early proliferative phase of the menstrual cycle in patients complaining of regular aub . aseptic precautions were employed by cleansing the cervix with betadine prior to insertion of the catheter . antibiotic prophylaxis was given if indicated , using doxycycline 100 mg bid for 5 days . the tvs was performed in an office setting by one of the two attendings in gynecology . the uterine anatomy and the adnexae were visualized using a 7.5 mhz vaginal probe transducer ( general electric , milwaukee , rt 3200 advantage ii real time sector scanner ) . appearance of the endometrial stripe was commented upon as either normal or abnormal ; a specific note was made of any focal lesion seen in terms of impression of an endometrial polyp , submucous fibroid , intramural fibroid , suspicion of hyperplasia or endometrial carcinoma . the contour of the endometrial stripe was assessed in the midline sagittal plane and the point of maximum thickness of the stripe ( et ) was measured on a frozen image at 1.5 magnification . office hysteroscopy ( oh ) was performed using a 3.6 mm single channel flexible hysteroscope ( hyf - p olympus america , ny ) with a fiberoptic cold light source ; normal saline was used as the distending medium and the procedure was performed under direct video monitoring . a total of 54 patients completed the study and underwent embx , tvs and oh . in none of the oh procedures was cervical dilatation required , nor was any form of local anesthetic used . baseline laboratory investigations included a complete blood count , results for which were available for 47 patients . the results of oh were taken as the  gold standard  for detection of intracavitary pathology as a contributing factor to the clinical presentation . sensitivity and specificity of the embx and tvs in detecting the intracavitary lesions were calculated . the sensitivity of clinical finding of an enlarged uterus and the pattern of bleeding in predicting an intracavitary lesion were also estimated , as was the association of significant anemia ( hb < 11 gm% ) and the incidence of concomitant intrauterine lesions . an age - related prevalence of intracavitary lesions ( submucous fibroids / polyps / endometrial hyperplasia / chronic endometritis / endometrial cancer ) was calculated in the study population . statistical analysis was performed using unpaired t tests using the statistical package graphpad in stat version 1.01 . thirteen patients were postmenopausal . fifty - two percent of the patients presenting with abnormal uterine bleeding had evidence of an intracavitary lesion as detected by office hysteroscopy . congenital uterine anomalies detected incidentally on oh included one case each of a unicornuate , and bicornuate and two cases of septate uterus . ( tvs ) performed detected a distortion of the endometrial cavity suggestive of a focal pathology in 20 patients . a subsequent oh confirmed the diagnosis in 17/20 cases where a focal lesion was suspected ( table 1 ) . however , of the 34 patients in whom tvs showed a normal endometrium , oh confirmed 11 false negative cases . the sensitivity of an abnormal transvaginal ultrasound scan when compared to office hysteroscopy for detection of an intracavitary lesion was thus calculated as 0.60 . of the 11 false negative tvs results , oh demonstrated five cases of endometrial polyp and six submucous myomas ; in 5/6 of the latter there was of the 54 patients who underwent tvs , a specific mention of the thickness of the endometrial stripe was available in 28 , the thickness of the endometrium ( et ) ranging from 1.8 mm to 25 mm . when correlating the thickness in mm with the presence of intracavitary lesions confirmed by oh , it was noted that the et  6 mm had a negative predictive value of 92% ; et of  10 mm had a positive predictive value of 89% . detection of intracavitary uterine lesions : comparison of results of office hysteroscopy to transvaginal ultrasound . tvs : transvaginal ultrasound the highest prevalence of intracavitary lesions was seen in the age group of 36 - 40 years ( 71% ) ; in the < 30 years age group , the incidence was 50% , the difference in the prevalence between the different ages not being of statistical significance ( table 2 ) . submucous myomas were the most common lesions seen in the younger patients ; an increasing incidence of endometrial polyps was seen with increasing age , polyps being the most frequently diagnosed pathology in the postmenopausal women , as shown in earlier studies . age related prevalence of intracavitary lesions determined by oh . the endometrial biopsy ( embx ) specimens were considered adequate for reporting in 49/54 cases ; two samples had inadequate tissue and three specimens showed menstrual blood , making interpretation difficult . no evidence of pathology was seen in 44/49 specimens . of the patients with a normal embx , 19 were true negative and 25 were false negative , when compared to results of oh ( table 3 ) . the negative predictive value of a normal embx was calculated as 51% . in 5/49 biopsy specimens , a pathology was detected and included fragments of endometrial polyp in two cases ; office hysteroscopy confirmed the presence of a residual polyp in one of these patients . there was evidence of chronic endometritis in one patient , in whom an endometrial polyp was detected on hysteroscopy , and focal hyperplasia within a secretory endometrium was shown in the fourth patient , who had a normal appearing endometrial cavity on oh . the sensitivity of endometrial biopsy was 0.04 with a specificity of 0.83 . no pathological evidence of endometrial carcinoma was detected in the embx specimens available , which included 14 specimens from postmenopausal patients . the incidence of inconclusive sampling was 9% and that of focal endometrial hyperplasia was 2% . detection of intracavitary uterine lesions : comparison of results 
 of office hysteroscopy to endometrial biopsy . difference between a and b is statistically significant p<0.05 of the 13 postmenopausal patients , the age range was 47 - 74 years ; seven patients were on some form of hrt for a period of at least three months prior to the presentation . the prevalence of intracavitary lesions in the post - menopausal group was 31% ( 4/13 ) ; two of the lesions were confirmed to be benign endometrial polyps on histology and the third was a submucous myoma ; in the fourth patient the biopsy of an irregular focal area of the endometrium provided a benign proliferative histological specimen . results of tvs specifically noted endometrial thickness in 10 postmenopausal patients , the thickness ranging from 1.8 mm -15 mm . in 7/10 patients , the et was < 6 mm and 6/7 had a normal uterine cavity of oh ; the seventh patient , a 72-year - old woman , was noted to have an area of endometrial irregularity on the anterior uterine wall and a directed biopsy performed showed histological evidence of proliferative endometrium with no evidence of malignancy . of the three postmenopausal patients in whom a tvs showed an endometrial thickness of greater than 6 mm , all were found to have an endometrial polyp on oh . thus taking the et of 6 mm as the cut - off in the postmenopausal women , the positive predictive value for detection of intracavitary lesions for et > 6 mm was deter - mined to be 100% , whereas the negative predictive value for an et of < 6 mm was also calculated as 100% . of the 54 patients included in the evaluation , 26 underwent definitive surgical management for the presenting problem ; two patients had a normal uterine cavity and opted to undergo endometrial ablation , whereas 24 had operative hysteroscopic resection of the focal lesion . the most common histological diagnosis was a submucous myoma , seen in 65% , followed by benign endometrial polyps in 26% of the resected lesions ; in 5% , a combination of the two existed . the uterus was classified as normal in size on clinical examination in 63% of the patients ( 36/54 ) . of the 18 enlarged uteri , 12 showed an intracavitary lesion on oh , giving a ppv of 67% . in eight of the 47 patients in whom a cbc was available , the hemoglobin was less than 11 gm% ; 6/8 ( 75% ) of these patients had an abnormal finding on oh . nineteen of the 54 patients were experiencing heavy , though regular menstrual flow ; of these , 14 ( 74% ) had an abnormal oh compared to 14/35 ( 40% ) of those presenting with irregular bleeding , the difference in the prevalence of lesions being statistically significant ( p=0.008 ) . the high incidence of intrauterine lesions ( 52% ) in our patient population presenting with abnormal uterine bleeding ( aub ) is consistent with results of earlier studies.1 the traditional approach to evaluation of aub in an outpatient setting has included an endometrial sampling following a preliminary assessment based on the history and clinical examination . the patient commonly makes an average of two to three clinic visits , depending on the urgency of presentation , before being commenced on a specific treatment protocol . in the present era of cost containment and capping of procedure related reimbursements , the physicians should be acquainted not only with the relative informative yield but also the cost per investigation , so as to channelize their diagnostic approach . the aim of management is to thus minimize the cost incurred per patient , while adhering to the principals of the standard of care . diagnostic hysteroscopy , though being increasingly employed for evaluation of aub , is still underutilized . since the introduction of the hysteroscopic technique , the procedure has undergone significant modifications , contributing to an increase in patient acceptance . introduction of fiberoptics , reduction in the caliber of the endoscopes , use of simpler distending media and availability of safer local infiltrative anesthetics have all contributed to an increasing utilization of this technique in evaluation of the uterine cavity . baskett et al . in a recent commentary on the efficiency of a one - stop menstrual clinic have demonstrated the cost and clinical effectiveness of utilizing hysteroscopy as a preliminary investigation performed at the initial visit in selected patients . more than 50% of all diagnostic hysteroscopies , however , are still being performed in the operating room ( or ) , and this trend could be attributed to a combination of a lack of awareness on the part of the physician and perhaps nonavailability of smaller caliber endoscopes . compared to tvs , hysteroscopy allows for a direct visualization of the endometrial cavity and hence detection of any focal lesion . it offers the additional opportunity of obtaining a directed biopsy in the same setting if indicated , thus obviating the need for a separate scheduling of the procedure . studies have demonstrated a superior yield of directed biopsies compared to d&c in providing representative histological specimens . in terms of cost containment , the procedure being performed by the investigating gynecologist precludes the involvement , and hence need for reimbursement of an additional specialist . furthermore , it dictates the need for a histological specimen if indicated , and allows for a directed biopsy , ensuring provision of a representative specimen of the focal pathology for evaluation . performing an oh early in the evaluation in appropriately selected patients would render utilization of any further investigation like embx or tvs unnecessary . the net result would ensure cost containment by reduction in the number of patient visits for investigational purposes , and by enabling the physician to embark on an appropriate management plan at the earliest opportunity , contribute significantly to patient satisfaction . the significant incidence of intrauterine lesions in the postmenopausal patients evaluated ( 31% ) is comparable to other studies and underscores the importance of direct visualization of the uterine cavity in this subgroup . since this represents the patient population at the highest risk for significant uterine pathology , i.e. endometrial carcinoma , and because the hysteroscopic appearances of early lesions are well recognized , the argument is further strengthened in favor for an early visualization of the cavity . an insight into the clinical staging of an existing endometrial carcinoma would be an additional benefit contributing to the final management plan . the high incidence of intracavitary lesions seen in the patients with clinically enlarged uteri ( 62% ) and in those with significant anemia ( 80% ) underscores the importance of proceeding with oh early in the evaluatory process in this subcategory of patients . the rationale for attempting to evaluate the endometrial specimen histologically , obtained by either d&c or outpatient biopsy , is to provide an early diagnosis of a significant pathology , namely endometrial cancer and/or endometrial hyperplasia . while the risk of such an occurrence is high in a subset of patients , i.e. postmenopausal women with abnormal bleeding ( 10% ) , anovulatory patients and those with a history of prior endometrial hyperplasia , the yield of endometrial sampling from the rest of the patient population in terms of obtaining a pathological diagnosis is negligible . this is consistent with our data and questions the almost universal practice of biopsying the endometrium in any patient presenting with aub . in our experience , an expenditure of approximately $ 250 for an embx could be easily avoided in the majority of premenopausal patients with aub . an embx , however , has a definite place in the diagnostic workup of postmenopausal patients as well as those premenopausal patients who are at high risk for endometrial hyperplasia . the high propensity of missing focal intrauterine lesions like submucous myomas and polyps with d&c is well documented in recent literature . moreover , the alleged therapeutic effect of d&c in the management of aub remains questionable . most of the data available on the diagnostic accuracy of tvs in evaluation of abnormal uterine bleeding is relevant only for the postmenopausal patients . the general consensus of opinion is that an endometrial thickness of less than 5 - 6 mm in a patient presenting with postmenopausal bleeding does not warrant an extensive workup , as the risk of endometrial carcinoma and/or hyperplasia is negligible.11,13 the sensitivity and specificity of tvs in detecting focal intrauterine lesions in the study presented is comparable to the results shown by tombin et al . ( 0.54 and 0.40 , respectively ) . scheduling the ultrasound evaluation in the follicular phase of the menstrual cycle in the premenopausal patients may enhance the sensitivity since the hyperechoic secretory endometrium may mask the endometrial polyps . presence of intramural myomas may obscure the endometrial stripe , thus contributing to a significant incidence of false negative interpretations , as shown in our series . the majority of pelvic ultrasound scans are still being performed by the radiologists ; the cost of a tvs ranges from $ 250-$400 , depending on the involvement of the radiology department . furthermore , an impression of an intracavitary lesion directs the management towards performance of a hysteroscopic procedure for the ultimate diagnosis and management . there is a high incidence of intracavitary uterine pathology in patients presenting with abnormal uterine bleeding . this is especially true when considering the 35 - 50 years age group who present with heavy regular bleeding , clinically enlarged uteri and significant anemia . the relatively poor sensitivity of both endometrial biopsy and transvaginal ultrasound in the detection of intrauterine focal pathology encourage us to propose that oh be utilized as a first line investigation in these patient evaluations . the cost - benefit analysis of investigations like embx and tvs as well as the financial burden of clinic visits during the entire evaluatory process
this is a prospective , observational study that utilizes hysteroscopy as the  gold standard  for evaluation of transvaginal ultrasound and endometrial biopsy in the detection of intrauterine pathology . 
 the sensitivity and specificity for detecting focal intrauterine lesions are examined in order to suggest the most cost - effective approach in patients with abnormal uterine bleeding .