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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Uppsala University Hospital | OTHER |
| University Hospital, Linkoeping | OTHER |
| Skane University Hospital |
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Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected.
Patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (VPI), which means difficulties in closing the passage between the oral and nasal cavities during speech. Velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization.
The most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. However, surgical management of VPI is challenging, with variable success rates reported in the literature. In a retrospectively based questionnaire study on patients who underwent surgical treatment of VPI, 30% experienced only a small speech improvement or no improvement at all. In addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. Thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance.
The aim with the current study is evaluation of speech function through patient- and parent-response outcome measurements following surgical treatment of velopharyngeal insufficiency in children with isolated or combined cleft palate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with cleft palate with velopharyngeal insufficiency undergoing surgical treatment | Children with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharyngeal flap | Procedure | Children with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap will be evaluated with patient- and parent reported outcome measures before and after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech function | Speech function will be evaluated through the patient response outcome measurement CLEFT-Q pre- and postoperatively. Each CLEFT-Q scale is transformed into scores that range from 0-100, with higher scores reflecting a better outcome. | Change in speech function will be evaluated preoperatively and 1 year postoperatively |
| Speech function | Speech function will be evaluated through the parent-response outcome measurement Intelligibility in Context Scale pre- and postoperatively. The maximum and minimum value ranges from 0-35 respectively, with higher scores reflecting a better outcome. | Change in speech function will be evaluated preoperatively and 1 year postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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All children < 18 years with isolated or combined cleft palate undergoing surgical treatment of velopharyngeal insufficiency in any of the 6 specialized cleft centers in Sweden will be invited to the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Wiberg, MD PhD | Contact | +46907850000 | rebecka.wiberg@umu.se | |
| Jenny Cajander, MD | Contact | +46907850000 | jenny.cajander@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Wiberg, MD PhD | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Not yet recruiting | Gothenburg | Sweden |
This is a multicenter study so the other researchers will be part of analysing the data, however only on group level.
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| OTHER |
| Sahlgrenska University Hospital | OTHER |
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| Linköping University Hospital | Not yet recruiting | Linköping | Sweden |
|
| Skånes University Hospital | Recruiting | Malmö | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
|
| Plastic Surgery Unit, Umeå University hospital | Recruiting | Umeå | Sweden |
|
| Uppsala University Hospital | Not yet recruiting | Uppsala | Sweden |
|
| ID | Term |
|---|---|
| D014681 | Velopharyngeal Insufficiency |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010608 | Pharyngeal Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D010038 | Otorhinolaryngologic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
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