Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients

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.

Study Overview

• Status: Completed
• Conditions: Developmental Disabilities; Cleft Palate; Cleft Lip; Unilateral Cleft Lip and Palate; Restricted Language Development
• Intervention / Treatment: Procedure: One stage Palate Surgical repair; Procedure: two stage palate surgical repair

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: one stage cleft palate surgery; Subjects submitted to one stage palate surgical repair after 9 months old and before 24 months old ,	Procedure: One stage Palate Surgical repair; One stage palate repair at the age of 9 to 24 months old
Active Comparator: two stage palate repair; 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)	Procedure: two stage palate surgical repair; two stage palate surgical repair with a hard palate closure at 3 to 4 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	between 4 to 5 years old

Collaborators and Investigators

• Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Collaborators: University of Sao Paulo
• Investigators: Study Director: Nivaldo Alonso, PH.D, USP

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: operative procedures
• Additional Relevant MeSH Terms: Mental Disorders; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Neurodevelopmental Disorders; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Cleft Lip; Developmental Disabilities
• Other Study ID Numbers: U1111-1158-3755; CADEFI /IMIP (Other Identifier: CADEFI/IMIP)