Does the usage of lubricant gel change the result of satisfactory in liquid-based Pap Smear?
Design
Randomize clinical trial with a parallel control group,one blinded,on 253 patient in each group that randomize with random number table.
Settings and conduct
In this study patients who come to Shariati hospital,gynecologic office is checked for indication of cervical cancer screening and pap smear,if it's positive after their informed consent they will be in intervention group or control with online randomize number table. Liquid-based pap smear will done for them by use of lubricant gel or water,then the specimen will study with pathologist.Patients and pathologist won't know whether the lubricant is used or not.
Participants/Inclusion and exclusion criteria
They are women more than 21 year old who candidate for cervical cancer screening;and if they don't accept to be in the study or if they have congenital uterine,cervical,vaginal anomaly or cervical cancer exclude from the study
Intervention groups
In intervention group after speculum lubricate with lubricant gel pap smear is done ,but in control group only water is used for this pupose.
Main outcome variables
satisfactory of sample
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160615028486N2
Registration date:2022-03-02, 1400/12/11
Registration timing:registered_while_recruiting
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Mansooreh Yaraghi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 0618
Email address
dr_m_yaraghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-01, 1400/11/12
Expected recruitment end date
2022-05-01, 1401/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lubricant gel on the satisfactory results of liquid-based Pap smear
Public title
Effect of lubricant gel on the satisfactory results of liquid-based Pap smear
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Screening for cervical cancer
Exclusion criteria:
History of cervical cancer
History of uterine,cervical,vaginal congenital anomaly
Patient disagreement
Age
From 21 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
506
Randomization (investigator's opinion)
Randomized
Randomization description
we search online randomize number in googl.com ,then we choose 253 number from 506 in kitset.ir/numbers/random .
Blinding (investigator's opinion)
Single blinded
Blinding description
Pap smear test is performed during gynecologic exam.The person who does it based on patient's number uses lubricant gel or not.The samples are sent to pathological laboratory and with other samples which aren't in the study and/or from other centers will be assessed by pathologists.They don't know if lubricant gel is used or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
506,6th foor,Centar building of Tehran University of Medical ScienceUniversity,Ghods Street,Keshavarz Street
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1308
Health conditions studied
1
Description of health condition studied
screening for malignant neoplasm of cervix
ICD-10 code
Z12.4
ICD-10 code description
Encounter for screening for malignant neoplasm of cervix
Primary outcomes
1
Description
Satisfactory result of Pap Smear in both group
Timepoint
When Pap Smear result is ready
Method of measurement
Pathologist reports for at least 5000 squamous cell in bottle
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: usage of lubricant gel ,Palizteb factory,water soluble ,with Carbomers ,on speculum during pap smear test.
Category
Diagnosis
2
Description
Control group:use of water on speculum during pap smear test.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital Gynecology Clinic
Full name of responsible person
Mansooreh Yaraghi
Street address
Jalal Al-Ahmad,North Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
Dr_m_yaraghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Street address
Jalal Al-Ahmad,North kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalal Al-Ahmad,North Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalal Al-Ahmad,North Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalal Al-Ahmad,North Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yhoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristic of patient,last coitus,last menstrual period,study result
When the data will become available and for how long
Three mounts after publication of result
To whom data/document is available
All people who work in this field
Under which criteria data/document could be used
every time
From where data/document is obtainable
Mansooreh Yaraghi
dr_m_yaraghi@yahoo.com
What processes are involved for a request to access data/document