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IRCT20201121049454N1 IRCT 2021-10-21 Shahid Beheshti University of Medical Sciences Comparison of cervical specimen margins obtained from LEEP surgery with and without colposcop Comparison of cervical specimen margins obtained from LEEP surgery with and without colposcop 2021-10-23 anticipated 140 Complete https://irct.ir/trial/52716 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A cervical cancer. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: After printing the results To whom: Researchers working in academic and scientific institutions Conditions: Provided that the complete details of the data are entered. Where to obtain: a.moridi@sbmu.ac.ir How to obtain: Send request via email Comments:
public Atefeh Moridi
Tehran .Shousha Fadaiyan Islam St. Shishe Garkhaneh St. Boroujerdi St. Mahdieh Hospital
Tehran Iran (Islamic Republic of) ۱۱۸۵۸۱۷۳۱۱ +98 21 5506 2628 a.moridi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Atefeh Moridi
Tehran .Shousha Fadaiyan Islam St. Shishe Garkhaneh St. Boroujerdi St. Mahdieh Hospital
Tehran Iran (Islamic Republic of) ۱۱۸۵۸۱۷۳۱۱ +98 21 5506 2628 a.moridi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients between the ages of 15 and 49 years referred to Mahdieh and Imam Hossein Hospitals who become LEEP candidates for any reason 15 years 49 years Female 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. Treatment - Surgery Treatment - Surgery 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 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 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. LEEP sample margin. Timepoint: After surgery with pathology results. Method of measurement: Negative or positive cases reported in pathology. Shahid Beheshti University of Medical Sciences Approved 2020-10-26 Ethics Committee in Biomedical Research of Shahid Beheshti University of Medical Sciences Iran TV Street Tehran Tehran Iran (Islamic Republic of)