|Year : 2019 | Volume
| Issue : 3 | Page : 355-361
Office cervicoscopy versus stationary colposcopy in cases with suspicious cervix: a randomized controlled trial
Momen A Kamel, Atef M Darwish, Kamal Zahran, Mostafa AboulEla
Department of Obstetrics and Gynecology - Women's Health Hospital - Assuit University, Assiut, Egypt
|Date of Submission||01-Jul-2018|
|Date of Acceptance||01-Jul-2018|
|Date of Web Publication||23-Sep-2019|
Women's Health University Hospital, 71111 Assiut
Source of Support: None, Conflict of Interest: None
To compare the diagnostic accuracy of small-caliber office cervicoscopy versus stationary colposcopy in diagnosis of ectocervical as well as endocervical lesions in women clinically presented with suspicious cervix.
Patients and methods
Eligible 112 cases with clinically suspicious cervix were randomized into group A (56 cases) and group B (56 cases) who were subjected to small-caliber office cervicoscopy and stationary colposcopy, respectively. The outcome was the diagnostic accuracy and safety of both tools for detection of ectocervical and endocervical cervical lesions.
There were no statistically significant differences between both groups regarding parity, previous abortion, age at marriage, duration of marriage, and age at menarche and menopause. Group A significantly reported more spontaneous vaginal bleeding. On unaided naked eye examination of the cervix, there were no statistically significant differences between both groups. Office cervicoscopy was more sensitive than colposcopy for detection of cervical abnormalities.
Office cervicoscopy is more sensitive than stationary colposcopy for detection of cervical lesions in cases with suspicious cervix as an example of high-risk group for cervical cancer. Moreover, its widespread use by gynecologists is highly recommended as it is more available in hospitals and clinics. Its small-caliber allows easy, simple and fast diagnostic out-patient evaluation of the cervix. Its better evaluation of the endocervical canal and possible examination of the endometrial cavity are clear advantages over stationary colposcopy.
Keywords: cervix, colposcopy, office cervicoscopy, suspicious, unhealthy looking
|How to cite this article:|
Kamel MA, Darwish AM, Zahran K, AboulEla M. Office cervicoscopy versus stationary colposcopy in cases with suspicious cervix: a randomized controlled trial. J Curr Med Res Pract 2019;4:355-61
|How to cite this URL:|
Kamel MA, Darwish AM, Zahran K, AboulEla M. Office cervicoscopy versus stationary colposcopy in cases with suspicious cervix: a randomized controlled trial. J Curr Med Res Pract [serial online] 2019 [cited 2019 Nov 21];4:355-61. Available from: http://www.jcmrp.eg.net/text.asp?2019/4/3/355/267680
| Introduction|| |
Cancer of the cervix is a global health problem. Fortunately, it is the only preventable gynecologic neoplasm in most cases owing to easy access to the cervix, that is, a malignancy of very early signs. Better knowledge of the evolution of the cervical neoplasia concerning timing and modalities of progression allows to follow-up a high number of low-grade lesions without treatment ,. Many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities . Abnormalities such as ectropion, nabothian cysts, and small cervical polyps are quite benign and may need not generate concern for patient or clinician, whereas others, including those associated with a history of exposure to diethylstilbestrol, cervical inflammation, abnormal cervical cytology, and postcoital bleeding, should require additional evaluation. Furthermore, in some patients, the cervix may be difficult to visualize. Several useful clinical suggestions for the optimal examination of the cervix are presented .
Papanicolaou (Pap) test is considered to be the most common and cost-effective screening method for detecting cervical cancer, and it has been effective in reducing the prevalence of this cancer and the associated mortality rates among women . Whenever access to Pap smear More Details is limited, unaided naked eye examination of the cervix (UNEE) performed by general gynecologists and well-trained nurses is an acceptable alternative for detecting cervical premalignant or malignant lesions especially in low-resource settings . Colposcopy is currently used for further management of abnormal Pap smears and is the second step of the diagnostic approach. The assessment of women with abnormal cytology and selection of those who require further therapy or follow-up depends on the colposcopic assessment of the transformation zone .
The availability of new instrumentation and video recording allows evaluating the cervical canal utilizing a standard office hysteroscopic instrument (cervicoscopy). Endocervicoscopy appears to be safe and effective office technique, improving the diagnostic workup of endocervical cervical intraepithelial lesions . The endocervicoscopy is particularly interesting regarding the way of endoscopic observations and to the successful identification of precarcinosis intercervicalis. The findings are of clinical importance in the early detection of precarcinomatic dysplastic processes and of neoplastic disease of the uterine endocervix. It is a valuable source of information in early treatment, surgery, and rehabilitation . However, so far, randomized comparison of cervicoscopy and colposcopy is missing in medical literature. Moreover, previously published studies have evaluated the endocervical canal without comment on the extocervix and the transformation zone in patients with negative or unsatisfactory colposcopy. The aim of this study was to compare the diagnostic accuracy of small-caliber office cervicoscopy versus stationary colposcopy in the diagnosis of ectocervical as well as ectocervical lesions in women clinically presented with suspicious cervix.
| Patients and Methods|| |
Study design and setting
This is a prospective cross-sectional interventional randomized controlled trial performed at the Early Cervical Cancer Detection Unit of the Woman's Health University Hospital, Assiut, Egypt, between July 2016 and December 2017. It was approved by the institutional review board of the Faculty of Medicine on June 2016.
This trial was internationally registered on clinicaltrial.gov (NCT03150745).
The study comprised 250 nonpregnant women with clinical diagnosis of unhealthy-looking (suspicious) cervix attending gynecologic, family planning, and infertility clinics at the Woman's Health Hospital, Assiut University, Egypt. The patients gave a written consent to participate in this study [Figure 1].
Sample size calculation
Sample size calculation was carried out using Epi Info software (version 7, Assuit university faculty of medicine department of general health, Center of Disease Control (CDC), Atlanta, Georgia, USA.) using confidence interval 95% and power 80%. So, total sample size was 112 patients who were divided into two groups.
Method of randomization
All eligible 112 cases were randomized using cards. A total of 112 cards were sequentially numbered. Opaque sealed envelopes were used containing 56 cards that were labeled office hysteroscopy and 56 cards that were labeled stationary colposcopy. All envelops were mixed together randomly in a box. The cards were selected randomly.
A thorough history was taken, with special emphasis on age and parity of the patients, age and duration of marriage, menstrual pattern, contraceptive history (with stress on type and duration of use), color and odor of vaginal discharge, pelvic pain, backache, or any associated symptoms. Examination in lithotomy position was done using a nonlubricated bivalve vaginal speculum. The cervix was cleaned from any secretions or blood using sterile 0.9% saline. A thorough naked-eye assessment (UNEE) of the cervix was done as previously described by our team . If a cervical lesion was seen, it was recorded and its site was marked on a special diagram. Cervical Pap smears were obtained using the long tip of an Ayre's spatula that was placed in the endocervical canal with the proximal bulge resting on the ectocervix. The spatula was carefully rotated around the cervix (360°) so that a representative sample of the whole cervix was obtained. An additional endocervical sample was obtained by placing the other end of the Ayre's spatula in the endocervical canal and gently rotated through 360° as previously described. The samples were then immediately plated on a slide, fixed by immersing the slide in 95% ethyl alcohol fixative for 15–20 min and stained by modified Pap stain using a hand staining procedure. Each smear was screened using modified Bethesda System terminology and checked for cytological evidence of inflammation and identification of cellular atypia, dysplasia, or carcinoma.
A total of 112 cases with clinically suspicious cervix were included in this study. They were classified into group A (56 cases) who were subjected to office cervicoscopy and group B (56 cases) who were examined by the stationary colposcope. In group A, office cervicoscopy was done using the same instruments used for office hysteroscopy (2.6 mm telescope, outer sheath 3.6 mm, a digital endocamera, and high-resolution monitor; Karl Storz, Tutlingen, Germany) and includes six steps: (a) 0.9% saline technique to assess the cervical lesion and vasculature of the cervix; (b) 5% acetic acid technique to determine acetowhite-positive areas, (c) Schiller's iodine technique to visualize high-glycogen containing cells, (d) endocervical canal assessment, (e) endometrial cavity evaluation whenever possible, and (f) biopsy using the punch biopsy forceps was obtained from every abnormal office cervicoscopic examination. In group B, stationary colposcopic examination was done using Karl Kaps Colposcope model (SOM 52) (Germany), and included five steps: (a) 0.9% saline technique to assess the cervical lesion and vasculature of the cervix, (b) 5% acetic acid technique to determine acetowhite-positive areas, (c) Schiller's iodine technique to visualize high-glycogen containing cells, (d) endocervical canal assessment using an endocervical speculum or counter pressure with Q stick, and (e) using punch biopsy forceps, biopsy was obtained from every abnormal colposcopic examination.
In both groups, women with positive findings were advised to continue follow-up care after proper management, and they were scheduled for follow-up examination at 3, 6, and 12 months thereafter until negative tests. Data entry was done using Epi-Info software version.
Outcomes of the study
The outcome was the diagnostic accuracy and safety of small-caliber office cervicoscopy versus stationary colposcopy for detection of ectocervical and endocervical cervical lesions.
Statistical analysis was performed using SPSS/PC (version 17) statistical software package (SPSS Inc., Chicago, Illinois, USA). Quality control was done at the stages of coding and data entry. Data were presented using descriptive statistics in the form of frequencies and percentages for qualitative variables and ranges, means and SD, medians, and quartiles for quantitative variables in box plots. The comparability of baseline characteristics according to outcome was ascertained by Student t-test (unpaired t-test) for continuous variables and Mann–Whitney U-test when appropriate, and χ2-test for categorical variables. To evaluate the univariate relation between variables, Pearson correlation coefficient was calculated. Values were considered significant if P is 0.05. With the aim of evaluating and comparing the diagnostic accuracy of UNEE, cytology, and colposcopy, office hysteroscopy and biopsy, the sensitivity and specificity tests were applied for each. Moreover, the predictive values of positive and negative results were calculated.
| Results|| |
This study comprised 112 women with clinically suspicious cervix subjected to either office cervicoscopy (group A) or stationary colposcopy (group B). There were no statistically significant differences between both groups regarding parity, previous abortion, age at marriage, duration of marriage, and age at menarche and menopause. However, women of the group A reported less regular menstrual pattern than group (B), which was statistically significant (P = 0.020). There was no statistically significant difference between both groups regarding risk factors for pre-invasive cervical lesions. Women of group A significantly reported more spontaneous vaginal bleeding [26 (46.4%) vs. 13 (23.2%), respectively; P= 0.010]. On UNEE of the studied women, ectopy was the commonest finding, and there were no statistically significant differences between both groups regarding cervical ectopy, cervical ectropion, cervical mass, nabothian cyst, cervical ulcer, hypertrophied cervix, cervical polyp, white spots, inflammatory spots, and cervical warts. Most cytology results were negative (67.3 and 67.9%) and unsatisfactory (32.7 and 28.6%) in group A and group B, respectively [Table 1]. Atypical glandular cells and atypical squamous cells were diagnosed in two cases in group B. Description of cervical biopsing in both groups is shown in [Table 2]. Details of histopathologic examinations are shown in [Figure 2], [Figure 3],[Figure 4] show office cervicoscopic findings. Office cervicoscopy was more sensitive than colposcopy for detection of cervical abnormalities, as shown in [Table 3].
|Table 3: Diagnostic efficacy of cervicoscope, colposcope, and Papanicolaou smear|
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|Figure 3: Office cervicoscopic appearance of immature metaplasia (a) and condyloma acuminatum (b).|
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| Discussion|| |
Worldwide, cervical cancer is the fourth most common cancer in women. Fortunately, owing to easy access to the cervix and subsequently ability to diagnose premalignant cervical lesions, premalignant cervical lesions can be promptly treated before real malignancy occurs at ∼17–25 years of age . Moreover, it is the only gynecologic cancer that can be prevented by vaccination and regular screening. Over the past 50 years, routine use of the Pap test to screen for cervical cancer has reduced deaths owing to the disease by more than 70%. A Pap smear is a sample of the cells in the cervix taken during a Pap test. Limitations include false-negative rate of 15–20%; inadequate sampling of the transformation zone; poor collection and fixation of the specimen; inclusion of excessive blood, inflammatory material, or necrotic material that can obscure or preclude the correct cytopathologic diagnosis; and deficient cytologists and well-equipped laboratories . In this study, Pap test was unsatisfactory in 18 (32.7%) and 16 (28.6%) in groups A and B, respectively. This means that approximately one-third of cases of cervical malignancy can be missed by Pap test. In a recent study, Pap test was unsatisfactory in 38% of cases . Moreover, many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities ,,. The Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology issued an Interim Guidance Report after the US Food and Drug Administration approved an human papilloma virus (HPV) test as a 'primary', or first, test performed for cervical cancer screening .
At our institution, owing to financial restrictions as well as technical difficulties accomplished with Pap test screening, we have focused on high-risk women since 1998. One of these groups is suspicious cervix which includes one or more of the following lesions: white or red patches, ectopy, polyps, nodular cervix with retention cyst, hypertrophied cervix, ulcer, purulent or persistent discharge and bleeding on touch, or postcoital bleeding .
The results of our study indicated that more than 60% of patient complained of vaginal discharge followed by backache in ∼60% and dyspareunia in ∼55% in both groups, which is in agreement with our previous study . Moreover, we reported abnormal uterine bleeding more in office cervicoscopic group (46.4 vs. 23.2%), being statistically significant, which could be attributed to more use of different methods of contraceptives in this group like COCs, IUCD, Depo-Provera, and Implanon (62.2, 54.1, 16.2, and 10.8% vs. 60.0, 47.5, 2.5, and 5.0% in groups A and B, respectively). On UNEE of the cervix, cervical ectopy was the commonest suspicious lesion which should not be ignored during routine speculum examination. In addition to recurrent cervicitis and postcoital bleeding, cervical ectopy is a precursor of cervical metaplasia which means change of columnar epithelium to squamous epithelium (cellular activity) with a possibility of abnormal cellular pathway to cellular dysplasia at the most dangerous part of the cervix (transformation zone).
A common problem of colposcopy is unsatisfactory examination of the endocervical canal. To overcome this problem, we usually use an endocervical speculum which adds little value particularly in nulliparous women with cervical stenosis. Others , performed endocervical curettage, which is a blind painful technique associated with excessive bleeding and high percentage of false-negative results. Here comes the valuable role of office cervicoscopy as an excellent tool to meticulously evaluate the endocervical canal. Despite being poorly reported in literature , it allows excellent view of the mucosa of whole endocervical canal and the internal cervical canal opening (OS). In this study, cervicoscopy could evaluate the transformation zone as it allows excellent view of the original (native) and new squamocolumnar junction almost in every case like others who reported nonvisualization of the squamocolumnar junction in only four (3.4%) patients because of external uterine orifice stenosis caused by previous cold knife conization. One of the advantages of this study is the use of office hysteroscope (2.6 mm telescope) as a cervicoscope will help overcome cervical stenosis in most of cases because of the advantage of under vision negotiation of the cervix. In a recent study, we proved that office hysteroscopic cervical negotiation of tight cervical stenosis was superior to blind cervical probing . It has the advantage of seeing endocervical kinking and to safely direct the telescope toward the 'black spot' of the internal OS. Owing to excellent illumination and proper magnification, office cervicoscopy can easily detect endo as well as ectocervical abnormal cervical lesions. In a previous study , we found that cervicoscopy was a simple, cheap, and office procedure that can be used as a quick screening tool of HPV infection in women with suspicious cervix. It had the advantage of screening of the rest of the genital tract. In the absence of laboratory HPV testing, performing cervicoscopy in conjunction with cytology screening of high-risk cases was encouraged.
In this study, office cervicoscopy succeeded to diagnose abnormal and inflammatory lesions in 14.3 and 85.7%, respectively, with no case of unsatisfactory examination. Contrarily, stationary colposcopy was unsatisfactory in 7.1%. This high sensitivity of office cervicoscopy can be attributed to the ability of the office telescope to freely examine the whole cervix and go inside the endocervical canal unlike colposcopic lens which is fixed at far distance from the cervix with the possibility of magnification again away from the cervix. In a previous study , cervicoscopic examination revealed 7.8% of CIN2–3 in patients with LSIL with inadequate or negative colposcopy. On the contrary, colposcopy was unsatisfactory in 30% of women at 12 months after LLETZ , in 34.3% in another study , and in 30% of nonpregnant women with abnormal cervical cytology .
An additional valuable advantage of this study is the use of a 2.6-mm telescope rather than using conventional 4 mm telescope, to minimize pain during examination of the endocervical canal. We reported no pain or tolerable pain during office cervicoscopy in 85.7% of patients. Using office endoscope has a high success rate and a low complication rate even when performed by a group of gynecologists with limited experience in the procedure. Compared with the conventional 4-mm hysteroscopy, it expresses greater diagnostic accuracy and lower cost. In one study , the mean charges, excluding professional fees, for the hospital were $1799 versus $62 for conventional and office hysteroscopy, respectively.
In this study, we performed cervical biopsy in all cases as histopathology is the cornerstone for diagnosing the nature of cervical lesions. It has been recommended since a long time that at colposcopy two or more biopsies should be taken .
This study was a prospective randomized controlled trial design including consecutive patients referred according to well-defined national guidelines that resulted in a low risk of selection bias. Moreover, patient evaluation including was uniformly structured. As all histology was revised, the risk of misclassification and random error was probably low. Single or multiple biopsies were taken from all patients, not just those that had abnormal Pap test results; this prevents misdiagnosis of any precancerous lesions. However, the main limitation of the study could be focusing on only one high-risk group (suspicious cervix) and relatively low sample size.
This study has a clear message: why to buy two instruments when one can do both the jobs? Office hysteroscopy is now available in almost all hospitals and gynecologic clinics. Most doctors do not buy colposcope but have office hysteroscope as an important diagnostic tool for abnormal uterine bleeding, recurrent pregnancy loss, and infertility. Our study calls for more practice of office cervicoscopy using the same instrument (office hysteroscope) as a substitute to the stationary colposcopy which is actually poorly found in many hospitals. By this way many cases of suspicious cervix would be offered prompt diagnostic tool without waiting for referral to a specialized unit with many lost cases. From this study, it is concluded that office cervicoscopy is more sensitive than stationary colposcopy for detection of cervical lesions in cases with suspicious cervix as an example of high-risk group for cervical cancer. Moreover, its widespread use by gynecologists is highly recommended as it is more available in hospitals and clinics. Its small-caliber allows easy, simple, and fast diagnostic outpatient evaluation of the cervix. Its better evaluation of the endocervical canal and possible examination of the endometrial cavity are clear advantages over stationary colposcopy.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]