Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150745
• Other study ID #: CLLC
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: May 13, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Suspicious cervix

2. Age between 20 to 60 years

Exclusion Criteria:

1. Previously diagnosed cervical lesions.

2. Pregnant women.

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Procedure:
• 3- Cervical Pap smears
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
• Colposcopic examination
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
• Office hysteroscopy
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.

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity of office hysteroscopy detection of cervical lesions		1 week
Primary	The sensitivity of colposcopy		1 week