Determining the effectiveness of botulinum toxin injection in improving the complication of sialocele after parotidectomy
Design
The clinical trial will have a control and intervention group, in parallel and double-blind, randomized by a simple randomization method using a closed envelope and a phase 2-3 clinical trial study on 100 patients.
Settings and conduct
A study was conducted on 100 patients referred to the clinic of Qaim Hospital in Mashhad, who were prescribed partial parotidectomy, they would be placed in the intervention and control groups in a parallel and double-blind trial (participant, evaluator) during Surgery after parotidectomy botulinum toxin injection will be performed in the intervention group and pressure dressing of the remaining complications will be performed in the control group, and the effect of this intervention on the swelling of the fistula and sialocele after surgery will be investigated.
Participants/Inclusion and exclusion criteria
Informed consent to enter the project and diagnosis of tumor in the parotid lobe, as well as benign pathological results in fine needle aspiration before surgery, no Botox in the last 3 months, and no sensitivity or allergic reaction to Botox are the main conditions for entering the study.
Intervention groups
In the intervention group, during parotidectomy surgery, 30 up to 40 units of diluted botulinum toxin will be injected deeply in multi areas based on the amount of remaining parotid tissue , but in the control group, during parotidectomy surgery, routine treatment will be performed according to its procedure and in the remaining area of the parotid tissue only pressure bandaged will be done.
Main outcome variables
Swelling of the fistula and sialocele
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210923052559N2
Registration date:2023-02-06, 1401/11/17
Registration timing:prospective
Last update:2023-02-06, 1401/11/17
Update count:0
Registration date
2023-02-06, 1401/11/17
Registrant information
Name
Farzaneh Iravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3723 1750
Email address
farzaneh.baroon@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-14, 1401/11/25
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of botulinum toxin injection in improving the complication of Sialocele after parotidectomy
Public title
Investigating the effect of botulinum toxin on parotidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tumor located in the superficial parotid lobe
Benign pathological results in preoperative fine needle aspiration
Full consent to enter the study
Exclusion criteria:
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.464
Health conditions studied
1
Description of health condition studied
Neoplasm of parotid gland
ICD-10 code
D11.0
ICD-10 code description
Benign neoplasm of parotid gland
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Kamran khazayeni
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
khazaenik@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour Mobarhan
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreyshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran khazayeni
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
khazaenik@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran khazayeni
Position
Associate professo
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
khazaenik@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kamran khazayeni
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
khazaenik@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available