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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of speech problems, as defined by the perceptual evaluation | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Araceli Diez-Fraile | Contact | +32 5045 9660 | araceli.diez-fraile@azsintjan.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of oral and maxillofacial surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV | Recruiting | Bruges | Belgium |
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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 | incidence of 30-day postoperative complications | within 30 days postoperative |
| PVRQOL questionnaire, as a measure of quality of life | 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 | COHIP questionnaire, as a measure of quality of life | at time of routine speech evaluation between age 5-7 years old |