Comparison of cervical specimen margins obtained from LEEP surgery with and without colposcopy
Design
The clinical trial has an intervention control group, with parallel groups, single blind and completely randomized. This study is performed on 140 patients. Rand function is done in Excel software for randomization.
Settings and conduct
All patients referred to the clinic of Mahdieh and Imam Hossein hospitals who become LEEP candidates for any reason are divided into two groups after obtaining consent. In one group, a colposcope is used during LEEP, and in the other group, without a colposcope and only after acetic acid is applied to the cervix and observed with a flat eye (VIA), LEEP is performed on patients who have been blinded. , Are entered completely randomly in each group and the LEEP operation is performed by two gynecological oncology fellowships and the samples are examined by an experienced pathologist.
Participants/Inclusion and exclusion criteria
Entry requirements: All patients referred to the clinic of Mahdieh and Imam Hossein hospitals That become LEEP candidates for any reason.
No entry conditions: Patients who do not consent to participate in the project Patients undergoing LEEP for the second time.
Intervention groups
All patients referred to the oncology clinic who have undergone colposcopy for any reason and are candidates for LEEP with pathological results based on CIN2 and CIN3 are admitted to the study after obtaining consent and are divided into two groups in a LEEP surgery group with colposcopy. It is performed during the operation and in the other group, the LEEP operation is performed by VIA method and the two groups are examined in terms of the sample size and the margin of the removed tissue.
Main outcome variables
Sample size and number of parts and margin of LEEP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201121049454N1
Registration date:2021-10-21, 1400/07/29
Registration timing:prospective
Last update:2021-10-21, 1400/07/29
Update count:0
Registration date
2021-10-21, 1400/07/29
Registrant information
Name
Atefeh Moridi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
a.moridi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cervical specimen margins obtained from LEEP surgery with and without colposcop
Public title
Comparison of cervical specimen margins obtained from LEEP surgery with and without colposcop
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients between the ages of 15 and 49 years referred to Mahdieh and Imam Hossein Hospitals who become LEEP candidates for any reason
Exclusion criteria:
Patients who do not consent to participate in the project
Patients undergoing LEEP for the second time
Patients under 15 years and over 49 years of age.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
140
More than 1 sample in each individual
Number of samples in each individual:
1
A patient who is candidate for LEEP and has her informed consent taken
Randomization (investigator's opinion)
Randomized
Randomization description
To equalize the two groups, we use the block randomization method. First, we consider the capacity of the block 4 and determine all permutations (6 blocks). All possible blocks are arranged as follows: Block 1: ABAB, Block 2: AABB, Block 3: ABBA, Block 4: BBAA, Block 5: BAAB and Block 6: BABA. We called these blocks randomly from numbers 1 to 6. Choose a random number between 1 and 6. For example, the number 4 was chosen randomly, so the first person receives treatment "B", the second person receives treatment "B", the third person receives treatment "A" and the fourth person receives treatment "A", which indicates the block 4 is the first block for patients entering the study. Then we select the second block at random. This process is repeated until we reach the desired sample.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are assigned to study A and B codes and until the end of the study, these codes are not decoding for patients. That is, participating people, until the end of the study, are not informed that LEEP surgery with colposcopy is for group A or B groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Shahid Beheshti University of Medical Sciences
Street address
Iran TV Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.SBMU.MSP.REC.1399.377
Health conditions studied
1
Description of health condition studied
cervical cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of parts and sample size of LEEP
Timepoint
After surgery with pathology results
Method of measurement
Number of pieces sent for pathology and length, width and height reported based on pathology answer
Secondary outcomes
1
Description
LEEP sample margin
Timepoint
After surgery with pathology results
Method of measurement
Negative or positive cases reported in pathology
Intervention groups
1
Description
Intervention group: All patients referred to the clinic of Mahdieh and Imam Hossein hospitals who are LEEP candidates for any reason are divided into two groups after obtaining consent. In one group, a colposcope is used during the LEEP and the cervix is viewed under armed vision. The LEEP operation is performed and the patients are entered into each group based on a random table. The LEEP operation is performed by two gynecological oncology fellowships. Examined by an experienced pathologist
Category
Treatment - Surgery
2
Description
Control group: Patients referred to the clinic of Mahdieh and Imam Hossein hospitals who are candidates for LEEP for any reason are divided into two groups after obtaining consent. In the control group during LEEP without colposcope and only after applying acetic acid on the cervix and view with the naked eye LEEP operation is performed by two gynecological oncology fellowships. Examined by an experienced pathologist
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Farah Farzaneh
Street address
Shahid Madani Street
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 5507 3430
Fax
Email
info@ehmc.ir
2
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Atefeh Muridi
Street address
Fadaiyan-e-Islam St. - Shishegar Khaneh Alley - Shahid Rajabnia St.
City
Tehran
Province
Tehran
Postal code
۱۱۸۵۸۱۷۳۱۱
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Atefeh Moridi
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2040
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Moridi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran .Shousha Fadaiyan Islam St. Shishe Garkhaneh St. Boroujerdi St. Mahdieh Hospital
City
Tehran
Province
Tehran
Postal code
۱۱۸۵۸۱۷۳۱۱
Phone
+98 21 5506 2628
Fax
Email
a.moridi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Moridi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran .Shousha Fadaiyan Islam St. Shishe Garkhaneh St. Boroujerdi St. Mahdieh Hospital
City
Tehran
Province
Tehran
Postal code
۱۱۸۵۸۱۷۳۱۱
Phone
+98 21 5506 2628
Fax
Email
a.moridi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Moridi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran .Shousha Fadaiyan Islam St. Shishe Garkhaneh St. Boroujerdi St. Mahdieh Hospital
City
Tehran
Province
Tehran
Postal code
۱۱۸۵۸۱۷۳۱۱
Phone
+98 21 5506 2628
Fax
Email
a.moridi@sbmu.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Provided that the complete details of the data are entered.
From where data/document is obtainable
a.moridi@sbmu.ac.ir
What processes are involved for a request to access data/document