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

NCT ID: NCT02329509

Last Updated: 2016-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-09-30

Brief 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.

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

Conditions

Unilateral Cleft Lip and Palate; Cleft Lip; Cleft Palate; Developmental Disabilities; Restricted Language Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

one stage cleft palate surgery

Subjects submitted to one stage palate surgical repair after 9 months old and before 24 months old ,

Group Type: ACTIVE_COMPARATOR

One stage Palate Surgical repair

Intervention Type: PROCEDURE

One stage palate repair at the age of 9 to 24 months old

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)

Group Type: ACTIVE_COMPARATOR

two stage palate surgical repair

Intervention Type: PROCEDURE

two stage palate surgical repair with a hard palate closure at 3 to 4 years old

Interventions

two stage palate surgical repair

two stage palate surgical repair with a hard palate closure at 3 to 4 years old

Intervention Type: PROCEDURE

One stage Palate Surgical repair

One stage palate repair at the age of 9 to 24 months old

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role: lead

Responsible Party

Rui Manuel Rodrigues Pereira

CADEFI Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nivaldo Alonso, PH.D

Role: STUDY_DIRECTOR

USP

Other Identifiers

CADEFI /IMIP

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1158-3755

Identifier Type: -

Identifier Source: org_study_id