]>
IRCT20210923052559N2 IRCT 2023-02-06 Mashhad University of Medical Sciences Investigating the effect of botulinum toxin on parotidectomy Evaluation the effectiveness of botulinum toxin injection in improving the complication of Sialocele after parotidectomy 2023-02-14 anticipated 100 Complete https://irct.ir/trial/68187 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done by www.randomization.com website . Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: The study subjects and those who evaluate the outcome will be unaware of the intervention and control groups. Of course, written consent is obtained from the patients, at the same time, the patients do not know what substance was used during the surgery, and the researcher evaluating the outcome does not know which group the patients belong to. 2-3 Neoplasm of parotid gland. Intervention 1: Intervention group: Patients of this group who have undergone partial parotidectomy surgery and during surgery a 500 cc vial is diluted with 2.5 cc of normal saline, each 0.5 cc of normal saline contains 100 units of Mesport and from this solution with this concentration is injected, the amount of botulinum toxin, which can vary between 30 and 40 units depending on the amount of remaining tissue from the parotid, is injected deeply in three to four areas of the remaining tissue from the parotid during surgery. Intervention 2: Control group: In the control group, surgery is performed according to the routine procedure, and in the remaining area of the parotid tissue, only compression dressing is performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We will make a decision after finishing the work and consulting with the project colleagues.
public Kamran khazayeni
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2649 khazaenik@mums.ac.ir Mashhad University of Medical Sciences scientific Kamran khazayeni
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2649 khazaenik@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Tumor located in the superficial parotid lobe Benign pathological results in preoperative fine needle aspiration Full consent to enter the study 18 years 75 years Both Facial paralysis before surgery History of Botox in the last 3 months Allergy or allergic reaction to Botox Pregnancy Breastfeeding History of spastic cerebral palsy Suffering from all types of severe respiratory failure D11.0 Benign neoplasm of parotid gland Treatment - Drugs Treatment - Other Intervention group: Patients of this group who have undergone partial parotidectomy surgery and during surgery a 500 cc vial is diluted with 2.5 cc of normal saline, each 0.5 cc of normal saline contains 100 units of Mesport and from this solution with this concentration is injected, the amount of botulinum toxin, which can vary between 30 and 40 units depending on the amount of remaining tissue from the parotid, is injected deeply in three to four areas of the remaining tissue from the parotid during surgery. Control group: In the control group, surgery is performed according to the routine procedure, and in the remaining area of the parotid tissue, only compression dressing is performed. Swelling of the fistula and sialocele. Timepoint: Before the start of the intervention and 48 hours after surgery and the use of botulinum toxin. Method of measurement: Sonography. Mashhad University of Medical Sciences Approved 2022-05-31 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)