velopharyngeal insufficiency
Conditions
Interventions
Autologous fat grafting for velopharyngeal insufficiency: <
Pre-operative phase>
Patients are admitted in the hospital one day before or on the day of the operation, after consultation with the anesthesiologists. <
Operation>
Operation is performed under general anesthesia with oral intubation. [fat harvesting] Fat is harvested from abdomen, thigh or buttocks with cannulas with tumescent method (tissues are injected with
post-operative phase>
Patients are extubated in the operating room and transferred to intensive care unit (ICU) for observation of airway. Oxygen is supplied to the patients based on the protocols of the ICU. Soft diet is
speaking loudly is not allowed to keep the surgical site stable
soft diet is continued. First hospital visit is scheduled at
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: Patients with velopharyngeal insufficiency after cleft palate repair. 2: Equal to or older than 12 years old at the timing of consent. 3: IQ >70 in the IQ test performed at or older than 5 years old, or attending regular classes. 4: Velopharyngeal function is in the middle 2 grades of 4-grade evaluation in the interview by speech therapist at the institution based on the Test for Cleft Palate Speech by Japanese Association of communication Disorders, 2007. 5: Antero-posterior velopharyengeal gap is equal to or greater than 5mm in the cephalogram at phonation. 6: Velopharyngeal insufficiency is confirmed in the fiberscopy. 7: DT90<0.2%, DI(3)<5 in overnight pulse oximetry. 8: Informed consent is obtained by the patient with document for patients equal to or older than 20 years old. Informed assent is obtained by the patient and informed consent is obtained by his / her guardian with document for patients under 20 years old.
Exclusion criteria
Exclusion criteria: 1: Associated with syndrome or multiple congenital anomalies which involve cleft palate as one of its features. 2: Patients under anti-coagulant therapy. 3: Patients with pre-existing infection at the surgical site. 4: Patients with malignant tumor. 5: Patients with comorbidities (such as hypertension, diabetes mellitus or metabolic disorders) that are not controlled or are advancing. 6: Patients at the risk of wound-healing (such as impaired blood flow). 7: Patients who are considered not suitable for general anesthesia by the anesthesiologists at the institution. 8: Patients who are considered not suitable for the study by the researcher of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Safety> Airway complications in acute phase: re-intubation 24 hours within extubation, or oxygen requirement 24 hours after extubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| <Safety> 1. Airway complications in late phase: DI(3)=>15 or DT90=>1 in overnight pulse oximetry at 1 and 6 months after operation. 2. Other adverse events related to surgery in acute phase: adverse events such as surgical site infection or bleeding that necessitate additional treatment 1 month within the operation. 3. Other adverse events related to surgery in late phase: adverse events such as sensory disturbance or deformation complained by patients and confirmed in medical examination at 6 months after the operation. 4. Other adverse events <Efficacy> 1. Velopharyngeal function and its subscales (nasal emission, hyper nasality, and distortion of consonants due to nasal emission) evaluated by speech therapist in the interview at 6 months after the operation. 2. Velopharyngeal function and its subscales (nasal emission, hyper nasality, and distortion of consonants due to nasal emission) evaluated by speech therapist in the audio-visual recording at 6 months after the operation (nasal emission is based on the evaluation in the interview). 3. Speech intelligibility evaluated by speech therapist in the interview at 6 months after the operation. 4. Speech intelligibility evaluated by speech therapist in the audio-visual recording at 6 months after the operation 5. Distance of antero-posterior velopharyngeal gap evaluated in cephalogram at phonation at 1 month and 6 months after the operation. 6. Form and motility of velopharyngeal space evaluated in fiberscopy at 6 months after the operation 7. Health-related quality of life at 6 months after the operation (2 speech-related domains of CLEFT-Q Japanese version) | — |
Countries
Japan
Contacts
Public ContactMakoto Hikosaka
National Center for Child Health and Development Department of Surgical Specialties, Division of Plastic Surgery
Outcome results
None listed