Fistula of Soft Palate (Disorder)NCT03055637
Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
A study testing Furlow double opposing z-plasty and Two flap palatoplasty in people with Fistula of Soft Palate (Disorder), run by Sarah Moustafa Mahmoud Fahmy El-Youtti.
Trial summary
Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Fistula of Soft Palate (Disorder)
- What is being tested?
- Furlow double opposing z-plasty and Two flap palatoplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2017to 19 May 2017
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of Repair from 9 to 12 months.
- Isolated Cleft Palate
- Operation time should nearly be the same for all patients
- Surgical skills done by same surgeon
- Both sexes
Who cannot join
- Patients with hypoplasia of palatal tissue.
- Patients with associated anomalies.
- Patients with associated syndromes.
- Other types of cleft palate.
About this study
Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.
Read the detailed description
Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. Up to 2 hours before the scheduled arrival time, give only clear liquids. Clear liquids include water, Pedialyte®, Kool-Aid® and juices you can see through, such as apple or white grape juice. In the 2 hours before the scheduled arrival time, give nothing to eat or drink. Induction of general anaesthesia will be administered followed by local anaethesia. Then, Surgical prodecure will be done either following the conventional two flap palatoplasty technique or the Furlow double-opposing z-plasty technique.
- Conditions
- Fistula of Soft Palate (Disorder)
- Being tested
- Furlow double opposing z-plasty, Two flap palatoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furlow double opposing z-plastyProcedure or surgery
- Furlow, (1986) has described a technique for palatoplasty combining the principles of mucosal lengthening with creation of an intact muscular sling in the palate with double opposing Z-plasty. On the soft palate, mirror image Z-plasties are drawn, one for the nasal musoca and the other oral flaps, the nasal flaps are developed and closed first .The oral flaps are then approximated. The defect created usually closes readily. The closure lines of the two soft plate layers do not overlap, minimizing the potential for contracture. Also, this repair permits closure of the hard palate without lateral incisions
Two flap palatoplastyProcedure or surgery
design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,
| Study group | Role | What they receive |
|---|---|---|
| patients with isolated cleft palate | Active comparator | Patients requiring isolated cleft palate repair Receives: Procedure: Furlow double opposing z-plasty; Procedure: Two flap palatoplasty |
| Patients with isolated cleft palate | Active comparator | Patients requiring isolated cleft palate repair Receives: Procedure: Furlow double opposing z-plasty; Procedure: Two flap palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fistula
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 posted16 Feb 2017
- Study start19 Feb 2017 (estimated)
- Primary completion19 May 2017 (estimated)
- Study completion19 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula of Soft Palate (Disorder)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Moustafa Mahmoud Fahmy El-Youtti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Moustafa Mahmoud Fahmy El-Youtti, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055637
- Sponsor's protocol ID
- 28902051202049
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 16 Feb 2017
- 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 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
- ClinicalTrials.gov ID
- NCT03055637
- Acronym / sponsor ID
- 28902051202049
- Conditions
- Fistula of Soft Palate (Disorder)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sarah Moustafa Mahmoud Fahmy El-YouttiUniversity, hospital or other
- Study start
- 19 Feb 2017 (estimated)
- Primary completion
- 19 May 2017 (estimated)
- Study completion
- 19 May 2017 (estimated)
- First posted
- 16 Feb 2017 (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.
Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.
Detailed description
Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. Up to 2 hours before the scheduled arrival time, give only clear liquids. Clear liquids include water, Pedialyte®, Kool-Aid® and juices you can see through, such as apple or white grape juice. In the 2 hours before the scheduled arrival time, give nothing to eat or drink. Induction of general anaesthesia will be administered followed by local anaethesia. Then, Surgical prodecure will be done either following the conventional two flap palatoplasty technique or the Furlow double-opposing z-plasty technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with isolated cleft palate | Active comparator | Procedure: Furlow double opposing z-plasty, Procedure: Two flap palatoplastyPatients requiring isolated cleft palate repair |
| Patients with isolated cleft palate | Active comparator | Procedure: Furlow double opposing z-plasty, Procedure: Two flap palatoplastyPatients requiring isolated cleft palate repair |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age of Repair from 9 to 12 months.
- Isolated Cleft Palate
- Operation time should nearly be the same for all patients
- Surgical skills done by same surgeon
- Both sexes
Key exclusion criteria (4 listed)
- Patients with hypoplasia of palatal tissue.
- Patients with associated anomalies.
- Patients with associated syndromes.
- Other types of cleft palate.
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 |
|---|---|---|
| Furlow double opposing z-plasty* Furlow, (1986) has described a technique for palatoplasty combining the principles of mucosal lengthening with creation of an intact muscular sling in the palate with double opposing Z-plasty. On the soft palate, mirror image Z-plasties are drawn, one for the nasal musoca and the other oral flaps, the nasal flaps are developed and closed first .The oral flaps are then approximated. The defect created usually closes readily. The closure lines of the two soft plate layers do not overlap, minimizing the potential for contracture. Also, this repair permits closure of the hard palate without lateral incisions | Procedure or surgery | Patients with isolated cleft palate, patients with isolated cleft palate |
| Two flap palatoplastydesign the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate, | Procedure or surgery | Patients with isolated cleft palate, patients with isolated cleft palate |
Primary outcome
Incidence of fistula
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Furlow double opposing z-plasty and Two flap palatoplasty in people with Fistula of Soft Palate (Disorder), run by Sarah Moustafa Mahmoud Fahmy El-Youtti.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Incidence of fistula (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 16 Feb 2017.