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IRCT20191123045476N2 IRCT 2021-02-19 Iran University of Medical Sciences Evaluation of the effect of Dilapane-S gel on preoperative cervical preparation Evaluation of the efficacy of dilapane-S gel in comparison with misoprostol during pre-hysteroscopic cervical preparation 2020-09-22 anticipated 120 Complete https://irct.ir/trial/53862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: اn this study, restricted randomization sampling method is used that the study groups have equal sample size. Random allocation rule is one of the limited random sampling methods used in the present study. And patients are equally divided into two groups. On how to randomize, researchers first determine a total sample size, then randomly assign a set of them to group A and the rest to group B. For example, in a study with a sample size of 200 people, 100 balls For intervention group A and 100 balls, for intervention group B, it is placed in a lottery container and then the balls are randomly removed from the container without replacement and the created sequence is recorded. This method is used for two or more group trials, Blinding description: Patients in the intervention group are placed with dilapane 6 hours before hysteroscopy. 6 hours later, before hysteroscopy, dilapane is removed and the patient is transferred to the operating room. In the control group, 6 hours before surgery (the night before surgery) will receive 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Company). How medications are prescribed to the surgeon who evaluates the outcome will be kept secret. The analyzer is also unaware of the type of medication being administered. 3 Hysteroscopy. Intervention 1: Intervention group: Patients in the intervention group undergoing placement with Dilapane S (3MM * 55MM) made by Kardan Elixir Company, 6 hours before hysteroscopy, which is first moistened with sterile water or saline, and then take the Dilapane S handle gently and without Excess pressure is applied to the cervical canal only when it passes through the external and internal holes. The Dilapan handle should be placed around the external hole and not go beyond it, and 6 hours later and before hysteroscopy to remove the Dilapan S handle only with Forceps are taken and a continuous downward pull is applied along the longitudinal axis of the dilator, which makes it easy and painless to exit. Intervention 2: Control group: In the control group, 6 hours before surgery (the night before surgery) will receive 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Company). Yes - There is a plan to make this available What will be shared: Following the publication of the article, confidential information such as patient profile and Hospital, ... deletion and other information Will be made available to researchers When: After publishing the article To whom: Medical specialists Conditions: Medical professionals can turn to data for research purposes gain access Where to obtain: Refer to the email of the responsible author How to obtain: Official and academic email to the responsible author Comments:
public Samaneh Rokhgireh
Sattar Khan .Mansouri St. Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 s.rokhgireh@gmail.com Iran University of Medical Sciences scientific Samaneh Rokhgireh
Sattar Khan .Mansouri St. Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 s.rokhgireh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Postmenopausal women (at least 1 year after the last menstrual cycle) or Nolipar or Multipar who have no history of natural childbirth are candidates for hysteroscopic surgery due to uterine myoma and uterine polyp. Postmenopausal women (at least more than 1 year after the last menstrual cycle) or Nolie Par or Multipar who have no history of normal delivery are candidates for hysteroscopic surgery due to increased endometrial thickness confirmed by ultrasound or abnormal vaginal bleeding 49 years 52 years Female Contraindications to hysteroscopy Recent or current pelvic infections Previous cervical surgery Confirmed cervical or breast malignancies Vaginal delivery history Hypersensitivity to misoprostol and prostaglandins Treatment - Devices Treatment - Drugs Intervention group: Patients in the intervention group undergoing placement with Dilapane S (3MM * 55MM) made by Kardan Elixir Company, 6 hours before hysteroscopy, which is first moistened with sterile water or saline, and then take the Dilapane S handle gently and without Excess pressure is applied to the cervical canal only when it passes through the external and internal holes. The Dilapan handle should be placed around the external hole and not go beyond it, and 6 hours later and before hysteroscopy to remove the Dilapan S handle only with Forceps are taken and a continuous downward pull is applied along the longitudinal axis of the dilator, which makes it easy and painless to exit. Control group: In the control group, 6 hours before surgery (the night before surgery) will receive 200 micrograms of vaginal misoprostol tablets (Sami Saz Pharmaceutical Company). Cervical dilatation. Timepoint: The time required to start dilatation until the arrival of a hysteroscope or resectoscope will be recorded as a conclusion. Method of measurement: Initially, the initial condition of the cervix, including the position and softness of the cervix, will be evaluated observably. No resistance is passed as dilatation before hysteroscopy and will be recorded as a conclusion. Our ultimate goal will be dilatation with Hagar number 10-8. Severe pain and bleeding after hysteroscopy. Timepoint: Immediately after the patient regains consciousness. Method of measurement: visual analog scale, which includes a table to evaluate the patient's pain and bleeding in the form of zero indicates painless and ten indicates severe and unbearable pain and bleeding. Iran University of Medical Sciences Approved 2020-11-07 Ethics Committee of Iran University of Medical Sciences Sattar Khan St., Maziar Mansouri St., Rasoul Akram Hospital Tehran Tehran Iran (Islamic Republic of) Approved 2020-11-07 Ethics Committee of Iran University of Medical Sciences Sattar Khan St., Maziar Mansouri St., Rasoul Akram Hospital Tehran Tehran Iran (Islamic Republic of)