Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

NCT03150745 | Withdrawn

• 1 other identifier: CLLC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Dysplasia

Outcome Measures

Primary Outcomes (2)

• The sensitivity of office hysteroscopy detection of cervical lesions

  1 week

• The sensitivity of colposcopy

  1 week

Study Arms (2)

Colposcopic group

OTHER

Procedure: 3- Cervical Pap smears; Procedure: Colposcopic examination

office hysteroscopic group

OTHER

Procedure: 3- Cervical Pap smears; Procedure: Office hysteroscopy

Interventions

3- Cervical Pap smears PROCEDURE

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 group; office hysteroscopic group

Colposcopic examination PROCEDURE

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

Colposcopic group

Office hysteroscopy PROCEDURE

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.

office hysteroscopic group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suspicious cervix
• Age between 20 to 60 years

You may not qualify if:

• Previously diagnosed cervical lesions.
• Pregnant women.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

EG (1)