Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-10-01
2025-04-01
Brief Summary
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Detailed Description
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The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain . The Bethesda System will be used for cytological interpretation.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Normal group
normal pap smear
Screening pap smear test
The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain
Abnormal group
Abnormal routine Pap smears will be classified according to latest Bethesda system into the following categories : Atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells cannot exclude high grade squamous intraepithelial lesion (ASC-H), low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma (SCC), atypical glandular cells of undetermined significance (AGUS), and adenocarcinoma (ADC).
Screening pap smear test
The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain
Interventions
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Screening pap smear test
The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.
The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain
Eligibility Criteria
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Inclusion Criteria
* Patients who didn't have their pap smear done in last 3 years .
* Patient who had previous abnormal pap smear and coming for follow up.
Exclusion Criteria
* Women who underwent total hysterectomy.
* Women who are pregnant.
* Patients whose pap smear was done in last 3 years with reassuring results.
21 Years
60 Years
FEMALE
Yes
Sponsors
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Sohag University
OTHER
Responsible Party
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Mostafa Ahmed Elsayed Radwan
Resident at Obstetrics and Gynecology department Faculty of Medicine, Sohag University
Locations
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Faculty of Medicine, Sohag University
Sohag, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Soh-Med-24-09-13MS
Identifier Type: -
Identifier Source: org_study_id
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