Evaluation of the effect of Pillar flap posterior technique to increase the length of the palate and improve the velopharyngeal insufficiency (vpi) in patients with cleft palate with velopharyngeal insufficiency
Determining the effect of the posterior Pilar Flap technique on the improvement of hyper nasality speech in patients with cleft palate
Design
After obtaining permission from the Medical Ethics Committee of Isfahan University of Medical Sciences, after identifying patients who are candidates for surgery to resolve the VPI problem, first a written consent is obtained from the patients or their companion .
Routine treatments and care and preoperative care are provided equally to all patients. The method of blinding will be that the physician who is administrator will perform the posterior pilar flap surgery , but the outcome of the operation is assessed by a skilled speech therapist who is not in the study. Only one group without randomization and one way blind without control group
Settings and conduct
patients enter the study at the time of admission to the hospital and fulfill the necessary conditions, respectively. It is a clinical trial without a control group that is performed in 1400&1401 in Al-Zahra Hospital in Isfahan
Participants/Inclusion and exclusion criteria
A patient with a hypernasality speech due to cleft palate, who is satisfied to participate in the study, and the patient's who discotinue subsequent visits to determine the state of recovery means leaving the study
Intervention groups
After being placed on the operating table, patients are subjected to cardiorespiratory monitoring and under general anesthesia, the posterior pillar flap operation is performed on them. In this technique, the posterior posterior mucosa of the flap is opened and the nasal mucosa is separated by z-plasty. The length of the palate is increased and the oral and nasal mucosa are repaired as a duct.
Postoperative care is provided for all patients and in addition training the necessary care to the patient
Main outcome variables
Correct patients' speech
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220101053590N1
Registration date:2022-02-01, 1400/11/12
Registration timing:registered_while_recruiting
Last update:2022-02-01, 1400/11/12
Update count:0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Azadeh sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3272 0215
Email address
sadeghiazadeh4847@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Pillar flap posterior technique to increase the length of the palate and improve the velopharyngeal insufficiency (vpi) in patients with cleft palate with velopharyngeal insufficiency
Public title
Improving the complication of nasal speech in patients with cleft palate by increasing the length of the palate with a new surgical method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with nasal talk disorder due to cleft palate
Do not have a lung infection and ear, nose and throat area during the operation
Patient or companion consent to participate in the study
Exclusion criteria:
Lack of subsequent patient visits to determine recovery status
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding will be that the physician performing the posterior pyloric flap surgery is performed, but the outcome of the operation is assessed by a skilled speech therapist who is not in the study.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences.Hezar gerib street
City
Isfahan
Province
Isfehan
Postal code
81746773461
Approval date
2021-11-22, 1400/09/01
Ethics committee reference number
IR.MUI.MED.REC.1400.646
Health conditions studied
1
Description of health condition studied
hyper nasal speech in cleft palate
ICD-10 code
Q00-Q99
ICD-10 code description
Congenital malformations,defomations and chromosomal abnormalities
Primary outcomes
1
Description
Percentage of people with improved speech in the nose after surgery
Timepoint
6 months and one year after surgery
Method of measurement
Nasoendoscopy and fluoroscopy and speech therapy
Secondary outcomes
1
Description
Vpi intensity
Timepoint
6 months and one year after surgery
Method of measurement
Nasoendoscopy and fluroscopy
Intervention groups
1
Description
Intervention group: Fluoroscopy, nasovandoscopy, and preoperative and postoperative speech therapy, as well as post-operative bed rest, are monitored by cardiorespirators, and under general anesthesia, the posterior pillar-flap operation is performed on them. In this technique, the posterior posterior mucosa of the flap is opened and the nasal mucosa is separated by z-plasty. The length of the palate is increased and the oral and nasal mucosa are repaired as a duct.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Azadeh sadeghi
Street address
Al-Zahra Educational and Medical Center.Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sadeghiazadeh4847@gmail.com
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services.Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sadeghiazadeh4847@gmail.com
Web page address
http://www.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Sadeghi
Position
Plastic Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Isfahan University of Medical Science,Hezar jrib Street,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sadeghiazadeh4847@gmail.com
Web page address
http://alzahra.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Sadeghi
Position
Plastic Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Educational and Medical Center.Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sadeghiazadeh4847@gmail.com
Web page address
http://alzahra.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Sadeghi
Position
Plastic Surgery Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Educational and Medical Center.Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sadeghiazadeh4847@gmail.com
Web page address
http://alzahra.mui.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available