A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow-Sommerlad Palatoplasty in Comparison to Modified Furlow Palatoplasty Alone (SPEAC)

February 24, 2022 updated by: Krisztian Nagy, AZ Sint-Jan AV

A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow Palatoplasty in Combination With Intravelar Veloplasty According to Sommerlad, or Modified Furlow Palatoplasty Alone

Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.

study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.

The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.

conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.

Study Overview

Status

Recruiting

Detailed Description

Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.

study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.

The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.

conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Brugge, Belgium
        • Recruiting
        • Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinically diagnosed cleft of the hard and/or soft palatum, that are treated surgically with a modified Furlow palatoplasty or a modified Furlow palatoplasty in combination with an intravelar veloplasty by Sommerlad. Patients should receive their postoperative care and annual speech evaluation by the cleft team of the AZ Sint-Jan Brugge-Oostende av.

Description

Inclusion Criteria:

  • Patients should have a clinically diagnosed cleft of the hard and/or soft palatum, with or without involvement of the lip or nose (Veau classification I to IV (see Appendix 1).
  • Patients should have undergone a modified Furlow palatoplasty or modified Furlow according to Sommerlad in the AZ Sint-Jan Brugge-Oostende av
  • Patients should receive their postoperative care and speech therapy by the cleft team of the general hospital Sint-Jan Bruges
  • Patients should be in the fifth life year at time of speech evaluation
  • Patients should be Dutch-speaking as a maternal language

Exclusion Criteria:

  • Patients not meeting the abovementioned inclusion criteria
  • Patients that received a corrective surgical procedure for velopharyngeal dysfunction after the modified Furlow technique alone, or in combination with the intravelar veloplasty by Sommerlad
  • Patients that are bi- or multilingual
  • Patients with clinically diagnosed mild hearing difficulties (i.e. ASHA classification: hearing loss >25dB)30
  • Patients with a clinically diagnosed stutter
  • Patients with clinically diagnosed cognitive and/or motoric disabilities
  • Patients that received intensive speech therapy prior to their fifth life year can be included, but will be analyzed separately(subgroup analysis)
  • Note: The number of patients with a uni- or bilateral cleft involving the lip or nose should be comparable between both groups, since this can interfere with speech and could bias comparison of speech outcome between different cleft subgroups.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Furlow group
All cleft palate patients surgically treated with a modified Furlow technique since January 2012
Furlow + Sommerlad group
All cleft palate patients surgically treated with a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)
Time Frame: at time of routine speech evaluation between age 5-7 years old
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)
at time of routine speech evaluation between age 5-7 years old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of speech problems, as defined by the perceptual evaluation
Time Frame: at time of routine speech evaluation between age 5-7 years old
prevalence of speech problems, as defined by the perceptual evaluation
at time of routine speech evaluation between age 5-7 years old
prevalence of speech problems, as defined by the objective speech evaluation (nasometry)
Time Frame: at time of routine speech evaluation between age 5-7 years old
prevalence of speech problems, as defined by the objective speech evaluation (nasometry)
at time of routine speech evaluation between age 5-7 years old
incidence of 30-day postoperative complications
Time Frame: within 30 days postoperative
incidence of 30-day postoperative complications
within 30 days postoperative
PVRQOL questionnaire, as a measure of quality of life
Time Frame: at time of routine speech evaluation between age 5-7 years old
PVRQOL questionnaire, as a measure of quality of life
at time of routine speech evaluation between age 5-7 years old
COHIP questionnaire, as a measure of quality of life
Time Frame: at time of routine speech evaluation between age 5-7 years old
COHIP questionnaire, as a measure of quality of life
at time of routine speech evaluation between age 5-7 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2017

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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