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

NCT03995199 | Unknown

• 1 other identifier: B049201629483
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate Children

Keywords

speech evaluation; modified Furlow palatoplasty; Sommerlad intravelar veloplasty

Outcome Measures

Primary Outcomes (1)

• proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)

  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 Outcomes (5)

• 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)

  at time of routine speech evaluation between age 5-7 years old

• incidence of 30-day postoperative complications

  within 30 days postoperative

• 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

  at time of routine speech evaluation between age 5-7 years old

Study Arms (2)

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

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Division of oral and maxillofacial surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

RECRUITING

Central Study Contacts

Araceli Diez-Fraile

CONTACT

+32 5045 9660; araceli.diez-fraile@azsintjan.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, maxillofacial surgeon

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: September 13, 2017
• Primary Completion: January 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)