Unilateral Cleft Lip and PalateNCT02329509
Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients
A study testing two stage palate surgical repair and One stage Palate Surgical repair in people with Unilateral Cleft Lip and Palate and Cleft Lip, run by Professor Fernando Figueira Integral Medicine Institute.
Trial summary
The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Unilateral Cleft Lip and Palate, Cleft Lip, Cleft Palate
- What is being tested?
- two stage palate surgical repair and One stage Palate Surgical repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2016
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015
Who cannot join
- Patients with associated syndromes that retard the neuro-psycho-motor and speech development;
- Patients without clinical conditions for performing the surgical chronology protocol;
- Patients whose parents or guardians who are not in accordance with the Informed Consent Statement proposed by the researcher
About this study
Official title: Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients. A Prospective Randomized Trial
The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth.
The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.
Read the detailed description
The study is being conducted at CADEFI- Centro de Atenção aos Defeitos da Face do IMIP (craniofacial center) in IMIP-Instituto de Medicina Integral Professor Fernando Figueira-, Recife PE- Pernambuco-, Brazil. All children were and will be operated by the same plastic surgeon in the operating room in IMIP. The sample size was calculated in 64 patients, 32 to GI ( one stage repair) and 32 to GII ( two stage repair, with a hard palate late closure), considering taking a statistical power of 90% with a 5% significance, determined with a difference of at least 25% between the two groups. Note : this sample was calculated for the dependent variable commonly present in patients with unilateral lip and palate cleft : atresia of the dental arches.
The groups are numbered in post op care attendance of the lip repair, according to randomization sequence done in computerized statistical program. The randomization is being held after the first month of the lip repair surgery. The surgeon, and parents or guardians (who have already signed the Informed Consent Form) will not have prior access to information on the type of allocation in each group. Subsequently it will be added in patients chart the record set for the patient group.
>Study Variables Independent variables:. Group I (palate closure in two surgical times and GII (closure of the palate in a surgical time) also will be considered independent variables age, sex, birth weight and maternal education.
Dependent variables: the presence of postoperative infection, initial and intermediate cleft sizes, dimensional changes of the transverse arch, the evaluation indexes of dental arch relationship(Goslom,Atack Yardsticks) and speech outcomes evaluation grades
- Conditions
- Unilateral Cleft Lip and Palate, Cleft Lip, Cleft Palate, Developmental Disabilities, Restricted Language Development
- Being tested
- two stage palate surgical repair, One stage Palate Surgical repair
- Keywords
- operative procedures
- Medical subject headings
- Cleft Lip, Cleft Palate, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two stage palate surgical repairProcedure or surgery
two stage palate surgical repair with a hard palate closure at 3 to 4 years old
One stage Palate Surgical repairProcedure or surgery
One stage palate repair at the age of 9 to 24 months old
| Study group | Role | What they receive |
|---|---|---|
| one stage cleft palate surgery | Active comparator | Subjects submitted to one stage palate surgical repair after 9 months old and before 24 months old , Receives: Procedure: One stage Palate Surgical repair |
| two stage palate repair | Active comparator | Subjects submitted to two stage palate surgical repair (first soft palate repair between 6 and 12 months old and hard palate closure at 3 to 4 years old) Receives: Procedure: two stage palate surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary Growth Evaluated by the Atack Yardstick
A system that evaluates facial growth , assessing dental arch relationships, and ranking them from 1 to 5, being 1 the best and 5 the worst outcome.Cases are allocated to these categories on a value judgment basis by reference to the anchor groups of the Atack Yardstick. This is performed by external judges, previously trained and evaluated
Measured: between 4 to 5 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2010
- Primary completionOct 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cleft Lip and PalateStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Rui Manuel Rodrigues Pereira, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Nivaldo Alonso, PH.D, Study director, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329509
- Sponsor's protocol ID
- U1111-1158-3755
- Other IDs
- CADEFI /IMIP
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2014
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients. A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02329509
- Acronym / sponsor ID
- U1111-1158-3755
- Conditions
- Unilateral Cleft Lip and Palate, Cleft Lip, Cleft Palate, Developmental Disabilities, Restricted Language Development
- Keywords
- operative procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jan 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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.
The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth.
The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.
Detailed description
The study is being conducted at CADEFI- Centro de Atenção aos Defeitos da Face do IMIP (craniofacial center) in IMIP-Instituto de Medicina Integral Professor Fernando Figueira-, Recife PE- Pernambuco-, Brazil. All children were and will be operated by the same plastic surgeon in the operating room in IMIP. The sample size was calculated in 64 patients, 32 to GI ( one stage repair) and 32 to GII ( two stage repair, with a hard palate late closure), considering taking a statistical power of 90% with a 5% significance, determined with a difference of at least 25% between the two groups. Note : this sample was calculated for the dependent variable commonly present in patients with unilateral lip and palate cleft : atresia of the dental arches.
The groups are numbered in post op care attendance of the lip repair, according to randomization sequence done in computerized statistical program. The randomization is being held after the first month of the lip repair surgery. The surgeon, and parents or guardians (who have already signed the Informed Consent Form) will not have prior access to information on the type of allocation in each group. Subsequently it will be added in patients chart the record set for the patient group.
>Study Variables Independent variables:. Group I (palate closure in two surgical times and GII (closure of the palate in a surgical time) also will be considered independent variables age, sex, birth weight and maternal education.
Dependent variables: the presence of postoperative infection, initial and intermediate cleft sizes, dimensional changes of the transverse arch, the evaluation indexes of dental arch relationship(Goslom,Atack Yardsticks) and speech outcomes evaluation grades
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one stage cleft palate surgery | Active comparator | Procedure: One stage Palate Surgical repairSubjects submitted to one stage palate surgical repair after 9 months old and before 24 months old , |
| two stage palate repair | Active comparator | Procedure: two stage palate surgical repairSubjects submitted to two stage palate surgical repair (first soft palate repair between 6 and 12 months old and hard palate closure at 3 to 4 years old) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015
Key exclusion criteria (3 listed)
- Patients with associated syndromes that retard the neuro-psycho-motor and speech development;
- Patients without clinical conditions for performing the surgical chronology protocol;
- Patients whose parents or guardians who are not in accordance with the Informed Consent Statement proposed by the researcher
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 |
|---|---|---|
| two stage palate surgical repairtwo stage palate surgical repair with a hard palate closure at 3 to 4 years old | Procedure or surgery | two stage palate repair |
| One stage Palate Surgical repairOne stage palate repair at the age of 9 to 24 months old | Procedure or surgery | one stage cleft palate surgery |
Primary outcome
Maxillary Growth Evaluated by the Atack Yardstick
Time frame: between 4 to 5 years old
A system that evaluates facial growth , assessing dental arch relationships, and ranking them from 1 to 5, being 1 the best and 5 the worst outcome.Cases are allocated to these categories on a value judgment basis by reference to the anchor groups of the Atack Yardstick. This is performed by external judges, previously trained and evaluated
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 2 Dec 2016.
Related trials for Unilateral Cleft Lip and Palate
Not yet recruiting
MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
Cleft Palate, Cleft Palate, Unilateral, Complete
RecruitingObservational study
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Cleft Lip and Cleft Palate
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.
Nivaldo Alonso, PH.D study director
USP
Questions about this trial
What is this clinical trial studying?
A study testing two stage palate surgical repair and One stage Palate Surgical repair in people with Unilateral Cleft Lip and Palate and Cleft Lip, run by Professor Fernando Figueira Integral Medicine Institute.
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 1 inclusion and 3 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 2 Dec 2016. 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?
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?
Maxillary Growth Evaluated by the Atack Yardstick (time frame: between 4 to 5 years old). 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 2 Dec 2016.