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IRCT20130812014333N206 IRCT 2023-08-11 Kermanshah University of Medical Sciences Comparative study of the success rate and complications of abdominal sacrohysteropexy with abdominal uterosacral in the treatment of uterine prolapses Comparative study of the success rate and complications of abdominal sacrohysteropexy with abdominal uterosacral in the treatment of uterine prolapses (a clinical trial) 2023-08-11 anticipated 30 Complete https://irct.ir/trial/71667 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code. N/A Uterine prolapse. Intervention 1: In the first intervention group (abdominal sacral hysteropexy method), after entering the abdomen, the sigmoid colon is pushed aside, and the location of the ureters is determined. The peritoneum is pushed aside on the promontory of the sacrum. In the area of the cervix and the back of the uterus, after separating the serous tissue, a polypropylene mesh with dimensions of 5 x 15 cm is connected to the back of the cervix and uterus and is connected to the promontory of the sacrum, and finally, the abdominal layers are closed. Intervention 2: In the second intervention group (abdominal uterosacral method), after opening the abdominal layers, the location of the uterosacral ligaments is determined, it is carefully separated from the ureters, and the uterus is connected to the uterosacral ligaments. Before closing the abdominal layers, the health of the ureters is ensured by performing a cystoscope, and then the abdominal layers are repaired in anatomical order. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Tahereh Parsajam
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 t.parsajam6368@gmail.com Kermanshah University of Medical Sciences scientific Dr. Firoozeh Veisi
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 firoozehveisi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Informed consent Patients with complaints of uterine-vaginal prolapse who want to preserve the uterus. Patients who are candidates for one of two abdominal sacrohysteropexy and abdominal high uterosacral suspension surgeries. no limit no limit Female urinary incontinence History of pelvic prolapse surgery Malignancy or dysplasia on Pap smear Immune system disorders, blood or coagulation disorders Contraindications to surgery Abnormal uterine bleeding Having a long cervix during examination N81.4 Uterovaginal prolapse, unspecified Treatment - Surgery Treatment - Surgery In the first intervention group (abdominal sacral hysteropexy method), after entering the abdomen, the sigmoid colon is pushed aside, and the location of the ureters is determined. The peritoneum is pushed aside on the promontory of the sacrum. In the area of the cervix and the back of the uterus, after separating the serous tissue, a polypropylene mesh with dimensions of 5 x 15 cm is connected to the back of the cervix and uterus and is connected to the promontory of the sacrum, and finally, the abdominal layers are closed. In the second intervention group (abdominal uterosacral method), after opening the abdominal layers, the location of the uterosacral ligaments is determined, it is carefully separated from the ureters, and the uterus is connected to the uterosacral ligaments. Before closing the abdominal layers, the health of the ureters is ensured by performing a cystoscope, and then the abdominal layers are repaired in anatomical order. The success of middle compartment surgery. Timepoint: At the beginning of the study and 12 months after surgery. Method of measurement: by the doctor (the distance between the point C and the hymen). Excretory and urinary complications. Timepoint: At the beginning of the study and 12 months after surgery. Method of measurement: Ask the patient. Kermanshah University of Medical Sciences Approved 2023-06-18 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)