Protocol summary
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Study aim
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Determination of complications of phrynctomy (bleeding, infection, movement limitation and tongue dysfunction) in neonates with ankylosing spondylitis using electrocautery and incision surgery
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Design
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Clinical trial with control group, with parallel, non-blind, simple randomized groups, on 20 patients. Excel software rand function was used for randomization.
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Settings and conduct
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Sampling is done after receiving the code of ethics from the university ethics committee. Patients will be randomly selected from patients referred to the ENT surgery clinic of Tabriz Children's Hospital. Diagnosis is by clinical examination and parental history. Patients will be selected based on the criteria of admission (parental consent and definitive diagnosis with history and clinical examination) and exclusion (unwillingness to continue treatment at any stage) and will be randomly divided into one of two groups A and B.
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Participants/Inclusion and exclusion criteria
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Age 6 months to 2 years; No previous procedure for ankyloglossia; Acceptance of research terms and procedures by parents; Lack of effective oral and tongue disease in the study results; Diagnosis of Ankyloglossia
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Intervention groups
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Intervention group: Using electrocautery (instead of surgery) for tongue phrenctomy. This method is safer and faster and has fewer complications Control group: Patients in this group undergo traditional surgical phrentomy.
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Main outcome variables
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Freedom of tongue movement in the mouth; Improves infant feeding
General information
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Reason for update
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Reducing the number of samples from 60 to 40. Due to the conditions and the spread of Covid-19
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Acronym
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فرنولوم زبان
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IRCT registration information
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IRCT registration number:
IRCT20150114020663N7
Registration date:
2021-10-31, 1400/08/09
Registration timing:
prospective
Last update:
2022-12-25, 1401/10/04
Update count:
1
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Registration date
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2021-10-31, 1400/08/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-11-11, 1400/08/20
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Expected recruitment end date
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2022-03-20, 1400/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation and comparision of surgical outcomes of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital
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Public title
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Evaluation and comparision of surgical outcomes and complications of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age6 months to 2 years
No previous procedure for ankyloglossia
Acceptance of research terms and procedures by parents
Lack of effective oral and tongue disease in the study results
Diagnosis of Ankyloglossia
Exclusion criteria:
Age above 2 years
Previous surgery on the tongue
Severe adhesion of the tongue to the floor of the mouth
Another severe underlying disease
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Age
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From 6 months old to 2 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned to intervention and control groups. Patients are distributed in two groups (random sequence) using a table of random numbers. Patients are divided between the two groups by announcing the number of patients in the clinic. Odd numbers in one group and even numbers in the second group. Patients are selected in the clinic of Tabriz Children's Hospital
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-04, 1400/07/12
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Ethics committee reference number
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IR.TBZMED.REC1400.634
Health conditions studied
1
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Description of health condition studied
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Ankyloglossia
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ICD-10 code
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Q38.1
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ICD-10 code description
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Ankyloglossia
Primary outcomes
1
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Description
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Answer to surgical or electrocautery treatment of the tongue ferronolum
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Timepoint
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6 months
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Method of measurement
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Physical examination
Secondary outcomes
1
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Description
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Good baby nutrition
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Timepoint
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6month and 1 year
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Method of measurement
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Weighing
Intervention groups
1
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Description
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Intervention group: Electrocautery. In this group of patients, the patient's tongue follicle is removed using the cauterization device in the operating room of Tabriz Children's Hospital. The cutter degree is set to cut 8. The incision is performed by the surgeon in one session and after the end of the work, the patient is monitored for recovery from bleeding under the tongue and edema.
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Category
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Treatment - Surgery
2
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Description
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Control group: surgery. In this group, patients undergo tongue follicle resection by traditional surgical method after general anesthesia using anesthesia and restoration with 0.4 vicryl suture. It is controlled for bleeding under the tongue and edema.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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"No more information"
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available