Cochrane · intervention · CD006703
Interventions for the management of submucous cleft palate
Cochrane Database of Systematic Reviews · 2008 · Cochrane Library
Oral HealthOral medicine and oral cancerOral and maxillofacial surgery2 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
8
current version
GRADE rated
0
No studies
4
Included studies
1
as reported
No studies 4 · 50%Ungraded 4 · 50%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Children or adolescents, 3 years or older, with an established diagnosis of velopharyngeal insufficiency (VPI) associated with submucous cleft palate; diagnosis made by a combination of perceptual speech assessment and objective evaluation (nasometry, videonasopharyngoscopy, multiview videofluoroscopy); all participants assessed for hearing ability (pure tone audiometry) and language development; participants with associated syndromic conditions excluded. | Participants aged 4 to 7 years with submucous cleft palate associated velopharyngeal insufficiency, gender unspecified; single trial conducted in Mexico (n=72) |
| Intervention | Surgical procedures, either against each other or no treatment, to correct velopharyngeal insufficiency (VPI) in submucous cleft palate (e.g. intravelar veloplasty, sphincter pharyngoplasty, pharyngeal flap, Furlow double-opposing Z-plasty). | Minimal incision palatopharyngoplasty (MIPP) (n=37) |
| Comparison | Another surgical procedure or no treatment | MIPP with additional individualised velopharyngeal surgery: pharyngeal flap (32) or sphincter pharyngoplasty (3) (n=35) |
| Outcomes | Primary: (1) perceptual speech assessment (articulation, hypernasality, hyponasality, mixed resonance, cul-de-sac resonance, nasal emission) by a professional speech-language therapist/pathologist; (2) instrumental assessment: (a) nasalance score by nasometry and pressure-flow measure, (b) videonasopharyngoscopy and multiview videofluoroscopy assessment of velopharyngeal gap size at rest and closure. Secondary: (1) quality of life (validated questionnaires); (2) self-esteem (validated questionnaires). Adverse effects: (1) failure of muscle fusion; (2) sleep apnoea or airway compromise; (3) unacceptable nasal resonance after repair. | Residual post-operative velopharyngeal insufficiency (n=72); Complete closure of velopharyngeal sphincter (n=72); Post-operative velopharyngeal gap size during closure (n=63); Failure of muscle fusion (n=72); Obstructive sleep apnoea (n=72) |
| Study designs | Only randomised controlled clinical trials (RCTs) | 1 double-blind RCT (Ysunza 2001), conducted in Mexico |
| Timing | Not specified | 3 months post-operatively |
Search date: 2007-03. Databases: Cochrane Oral Health Group Trials Register; Cochrane Developmental, Psychosocial and Learning Problems Group Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; ERIC; PsycINFO
Questions and results
Current version onlyMinimal incision palatopharyngoplasty (MIPP) vs MIPP with additional individualised velopharyngeal surgery (pharyngeal flap or sphincter pharyngoplasty)
Population: Children or adolescents aged 3 years or older with velopharyngeal insufficiency (VPI) associated with non-syndromic submucous cleft palate
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Quality of life (self or carer evaluated, validated questionnaires) | No data were available for this patient-reported outcome in the single included trial. | 0 studies | No studies |
Instrumental assessment: nasalance score (nasometry and pressure-flow measure) | Nasalance score by nasometry and pressure-flow measure: the single included trial (Ysunza 2001) provided no data for this outcome. | 0 studies | No studies |
Self-esteem (validated questionnaires) | No data were available for this patient-reported outcome in the single included trial. | 0 studies | No studies |
Instrumental assessment: velopharyngeal complete closure and gap size (videonasopharyngoscopy and multiview videofluoroscopy) 3 months post-operatively | Complete closure occurred in 32 (86%) of the participants in group 1 (MIPP) and in 31 (89%) in group 2, P > 0.05. After eliminating the nine patients with residual velopharyngeal insufficiency, the post-operative gap… | 1 study · 72 participants | Ungraded |
Adverse effect: failure of muscle fusion in the region of the cleft after surgery | There were no reports of failure of muscle fusion after surgery. | 1 study · 72 participants | Ungraded |
Adverse effect: unacceptable nasal resonance after repair | The trial report provided no information on this adverse event; no information on adverse events or serious complications was reported. | 0 studies | No studies |
Adverse effect: obstructive sleep apnoea or airway compromise | The investigators stated that none of the participants reported obstructive sleep apnoea after the interventions. | 1 study · 72 participants | Ungraded |
Perceptual speech assessment: residual post-operative velopharyngeal insufficiency 3 months post-operatively | Five (14%) of the participants in group 1 (MIPP) and four (11%) in group 2 had residual post-operative velopharyngeal insufficiency, P > 0.05. The report provided no details on post-operative speech assessment other… | 1 study · 72 participants | Ungraded |
Surgical procedure to correct velopharyngeal insufficiency (e.g. intravelar veloplasty, sphincter pharyngoplasty, pharyngeal flap, Furlow double-opposing Z-plasty) vs A different surgical procedure or no treatment
Population: Children or adolescents aged 3 years or older with velopharyngeal insufficiency (VPI) associated with non-syndromic submucous cleft palate
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol (2007); planned comparison of surgical interventions to correct velopharyngeal insufficiency in submucous cleft palate; no results reported. | 0 studies | No studies |