Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

Study Overview
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Brief Summary
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Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so that the canal is kept closed. The original squamous epithelium is clearly identified as a smooth, usually featureless covering of the cervix; its uniform pink color contrasts with the redness of the original columnar epithelium. It joins the latter at the original squamocolumnar junction. Many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps are quite benign and 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 prompt additional evaluation. Further, in some patients, the cervix may be difficult to visualize. Several useful clinical suggestions for the optimal examination of the cervix are presented.

Official Title
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Office Hysteroscopy Versus Stationary Coloposcopy for Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

Conditions
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Cervical Dysplasia

Intervention / Treatment
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* Procedure: 3- Cervical Pap smears
* Procedure: Colposcopic examination
* Procedure: Office hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicious cervix Age between 20 to 60 years Exclusion Criteria: Previously diagnosed cervical lesions. Pregnant women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Colposcopic group<br> | Procedure: 3- Cervical Pap smears<br>* Cervical Pap smears will be obtained using the long tip of an Ayre's spatula that will be placed in the endocervical canal with the proximal bulge resting on the ectocervix. The spatula will be carefully rotated around the cervix so that a representative sample of the whole cervix will be obtained. An additional endocervical sample will be obtained by placing a cytobrush or by the other end of the Ayer's spatula in the endocervical canal and gently rotated through 360 degrees as previously described. The samples will be then immediately plated on a slide, fixed by immersing the slide in 95% ethyl alcohol fixative for 15 to 20 minutes and stained by modified Papanicolaou stain using a hand staining procedure<br>Procedure: Colposcopic examination<br>* 0.9% saline technique to assess the cervical lesion and vasculature of the cervix, 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment using (Bossman forceps or endocervical speculum or counter pressure with Q stick). e- Biopsy using the punch biopsy forceps. Biopsy will be obtained from every abnormal colposcopic examination<br>|
| Other: office hysteroscopic group<br> | Procedure: 3- Cervical Pap smears<br>* Cervical Pap smears will be obtained using the long tip of an Ayre's spatula that will be placed in the endocervical canal with the proximal bulge resting on the ectocervix. The spatula will be carefully rotated around the cervix so that a representative sample of the whole cervix will be obtained. An additional endocervical sample will be obtained by placing a cytobrush or by the other end of the Ayer's spatula in the endocervical canal and gently rotated through 360 degrees as previously described. The samples will be then immediately plated on a slide, fixed by immersing the slide in 95% ethyl alcohol fixative for 15 to 20 minutes and stained by modified Papanicolaou stain using a hand staining procedure<br>Procedure: Office hysteroscopy<br>* 0.9% saline technique to assess the cervical lesion and vasculature of the cervix. 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment. Endometrial cavity evaluation whenever possible. Biopsy. Biopsy will be obtained from every abnormal hysteroscopic examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of office hysteroscopy detection of cervical lesions |  | 1 week | 
| The sensitivity of colposcopy |  | 1 week |