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IRCT20180130038567N2 IRCT 2018-09-30 Iran University of Medical Sciences Comparison of thermal damage between harmonic and monopolar energy in laparoscopic hysterectomy Comparison of lateral thermal damage during colpotomy using harmonic scalpel versus monopolar diathermy in women undergoing laparoscopic hysterectomy 2018-10-07 anticipated 70 Complete https://irct.ir/trial/33902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 70 women undergoing laparoscopic hysterectomy will be divided into two groups of 35 using simple randomization method, Blinding description: Double-blinding ( patients and outcome investigators will not be aware of the allocation and the surgeons will be informed of randomization only on the day of surgery). Since the device is used during surgery when the patient is anesthetized, she will be actually blind to the randomization. N/A Benign uterine diseases. Intervention 1: Intervention group: 35 women for whom, ultrasonic device (Harmonic) is used for colpotomy. Intervention 2: Control group: 35 women in whom, monopolar device is used for colpotomoy. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information is available
public Shahla Chaichian
Rasoul-e-Akram Hospital, Satarkhan St
Tehran Iran (Islamic Republic of) 1449614535 +98 21 64351 shahlachaichian@yahoo.com Iran University of Medical Sciences scientific Shahla Chaichian
Rasoul-e-Akram Hospital, Satarkhan St
Tehran Iran (Islamic Republic of) 1449614535 +98 21 64351 shahlachaichian@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Women in age range 18-60 Women diagnosed with benign gynecologic diseases including myoma, adnomyosis ... who are candidates for total laparoscopic hysterectomy Not suffering from background diseases affecting wound healing process including immune deficiency, long-term use of corticosteroids or history of pelvic irradiation 18 years 60 years Female َAny woman suspicious of cervical or vaginal malignancy Presence of active vaginal infection during last 30 days Use of antibiotics other than the preoperative prophylaxis N71.9 Inflammatory diseases of uterus, unspecified Treatment - Surgery Treatment - Surgery Intervention group: 35 women for whom, ultrasonic device (Harmonic) is used for colpotomy. Control group: 35 women in whom, monopolar device is used for colpotomoy. Measuring the depth of lateral thermal damage developed in cervical tissue. Timepoint: within 72 hours after intervention. Method of measurement: measuring with specific microscope used by pathologist. Iran University of Medical Sciences Approved 2018-08-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)