]>
IRCT20190106042251N1 IRCT 2019-08-17 Shiraz University of Medical Sciences Efficiency of Tonsillectomy Bipolar Resection device in tonsillectomy Comparison of the effects of two methods of Cold Dissection and "Tonsillectomy Bipolar Resection" in patients aged 5 to 15 years undergoing tonsillectomy with or without adenoidectomy 2019-03-06 anticipated 76 Complete https://irct.ir/trial/36643 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, patients and their parents, researchers, clinical caregivers, and data analyzers are blind. Surgery is done by the ENT surgeon and the information is given to the researcher irrespective of the type of surgical procedure.Coding is also used to analyze data. N/A Tonsillectomy. Intervention 1: Control group: In this group, tansillectomy is common with cold dissection. Adenoidectomy was performed in patients using Curettes and then a pack of nasopharyngeal for homeostasis was performed. In tonsillectomy, a first sharper dissection was made and a mucosal incision was performed with a knife. At the end, the snare will be used to amputate the tonsile in the lower pole. Patch and suture are also used to control bleeding. Intervention 2: Intervention group: Patients treated with Tonsillectomy Bipolar Ressection. As the surgeon draws the special wire behind the tonsils, then after the fixation of the wire, the coagulation button is pressed to simultaneously cut and coagulate. Yes - There is a plan to make this available What will be shared: All data, except the device's technical map, can be shared after being unidentified. When: Start the access period 3 months after printing the results To whom: All scholars working in academic and scientific institutions Conditions: Creating a Better Quality and Performance Device for Tonsillectomy Under the Inventor of this Device (Researcher) Where to obtain: For more information, please call 00989017680793 or email Fakhrealizadeh@sums.ac.ir How to obtain: Setting up a contract for any change in the invention of the researcher Comments:
public Jamshid Eslami
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4257 Jam_Eslami@yahoo.com Shiraz University of Medical Sciences scientific Fatemeh Fakhrealizadeh
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3632 2612 Fakhrealizadeh@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Having satisfaction with the study Getting the consent and full cooperation of the parents of children The need for performing Tonsillectomy Staying in Shiraz Children in the age range of 5 to 15 years 5 years 15 years Both Preoperative infection Having bleeding diseases Disturbances in coagulation tests (PLT, PT, PTT, INR) Having a mental retardation Chronic underlying diseases (diabetes, cancer, etc.) Treatment - Surgery Treatment - Devices Control group: In this group, tansillectomy is common with cold dissection. Adenoidectomy was performed in patients using Curettes and then a pack of nasopharyngeal for homeostasis was performed. In tonsillectomy, a first sharper dissection was made and a mucosal incision was performed with a knife. At the end, the snare will be used to amputate the tonsile in the lower pole. Patch and suture are also used to control bleeding. Intervention group: Patients treated with Tonsillectomy Bipolar Ressection. As the surgeon draws the special wire behind the tonsils, then after the fixation of the wire, the coagulation button is pressed to simultaneously cut and coagulate. User-friendly device. Timepoint: Immediately after the intervention. Method of measurement: Davis & Venkatesh technology acceptance questionnaire. The amount of bleeding during and after surgery. Timepoint: During the intervention, 1, 3 and 7 days after the intervention. Method of measurement: Subtracting the weight of blood-stained gauzes from the weight of surgical gauzes. Mortality. Timepoint: 1, 3 and 7 days after the intervention. Method of measurement: Percentage of deaths in a month. Shiraz University of Medical Sciences Approved 2019-06-23 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)