Cleft PalateNCT05166408
Fistiulation Rate Following Primary Cleft Repair≤
A study testing Buccinator myomucosal flap and Bardach two flap palatoplasty in people with Cleft Palate, run by Cairo University at 1 site in Egypt.
Trial summary
Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator… Read more about this study
- Who is it for?
- Ages 9 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Buccinator myomucosal flap and Bardach two flap palatoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2019to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients suffering from complete wide cleft palate more than 10 mm
- Patients age from 9 to 18 months
- Patients free from any systemic disease that might affect normal healing or the predictable outcome
- Patients who will agree to the consent and stick to the follow up period
Who cannot join
- Patients with systemic disease
- Patients who might not stick to the follow up period
- Patients with Pierre Robin syndrome
- Patients with previous palatal repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Technique Predicting Velopharyngeal Insufficiency Risk in Newborns Following Primary Cleft Repair. A Randomised Clinical Trial Comparing Buccinator Flap and Bardach; Two-flap Palatoplasty.
Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate.
Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.
Read the detailed description
Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate.
Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.
- Conditions
- Cleft Palate
- Being tested
- Buccinator myomucosal flap, Bardach two flap palatoplasty
- Keywords
- Cleft palate, Primary repair, Buccinator flap, Palatal fistula
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccinator myomucosal flapProcedure or surgery
Buccinator myomucosal flap for primary cleft palate palatoplasty
Bardach two flap palatoplastyProcedure or surgery
Bardach two flap palatoplasty
| Study group | Role | What they receive |
|---|---|---|
| Buccinator myomucosal flap for primary cleft repair | Other | Study group Receives: Procedure: Buccinator myomucosal flap |
| Bardach two flap palatoplasty for primary cleft repair | Other | Control group Receives: Procedure: Bardach two flap palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistiulation rate
The rate of palatal fistula formation following primary cleft palate repair ( number of patients complicated with palatal fistula compared to the full patients number)
Measured: 6 months
Secondary outcomes (1)
Palatal length & risk of VPI
The length of soft palate after surgical repair in correlation with the risk of future velopharyngeal insufficiency ( linear scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start24 Sep 2019
- Primary completion1 Jan 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Kadry, Cairo University
- Investigators
- Wael Abdelsamee, Study chair, Research organizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166408
- Sponsor's protocol ID
- Primary palatoplasty fistula
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique Predicting Velopharyngeal Insufficiency Risk in Newborns Following Primary Cleft Repair. A Randomised Clinical Trial Comparing Buccinator Flap and Bardach; Two-flap Palatoplasty.
- ClinicalTrials.gov ID
- NCT05166408
- Acronym / sponsor ID
- Primary palatoplasty fistula
- Conditions
- Cleft Palate
- Keywords
- Cleft palate, Primary repair, Buccinator flap, Palatal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate.
Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.
Detailed description
Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate.
Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccinator myomucosal flap for primary cleft repair | Other | Procedure: Buccinator myomucosal flapStudy group |
| Bardach two flap palatoplasty for primary cleft repair | Other | Procedure: Bardach two flap palatoplastyControl group |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- patients suffering from complete wide cleft palate more than 10 mm
- Patients age from 9 to 18 months
- Patients free from any systemic disease that might affect normal healing or the predictable outcome
- Patients who will agree to the consent and stick to the follow up period
Key exclusion criteria (4 listed)
- Patients with systemic disease
- Patients who might not stick to the follow up period
- Patients with Pierre Robin syndrome
- Patients with previous palatal repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccinator myomucosal flapBuccinator myomucosal flap for primary cleft palate palatoplasty | Procedure or surgery | Buccinator myomucosal flap for primary cleft repair |
| Bardach two flap palatoplastyBardach two flap palatoplasty | Procedure or surgery | Bardach two flap palatoplasty for primary cleft repair |
Primary outcome
Fistiulation rate
Time frame: 6 months
The rate of palatal fistula formation following primary cleft palate repair ( number of patients complicated with palatal fistula compared to the full patients number)
1 secondary outcome
Palatal length & risk of VPI
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Abdelsamee study chair
Research organizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccinator myomucosal flap and Bardach two flap palatoplasty in people with Cleft Palate, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistiulation rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.