What's New in Cleft Palate and Velopharyngeal Dysfunction Management: An Update.

LEARNING OBJECTIVES: After studying this article, the participant should be able to: (1) Describe the pathology of velopharyngeal dysfunction (VPD) as it relates to patients with a cleft palate. (2) Use the perceptual speech assessment and objective diagnostic tools to determine the presence or absence of VPD. (3) Describe the surgical options available for the treatment of patients with VPD. (4) Develop an evidence-based, customized treatment plan for VPD founded on objective considerations. SUMMARY: To treat patients with cleft palate effectively, the surgeon must understand the diagnosis and surgical management of cleft-associated velopharyngeal dysfunction. The authors review diagnostic modalities including perceptual speech assessment, video nasendoscopy, fluoroscopy, magnetic resonance imaging, and nasometry. Surgical treatments including palatal lengthening with buccal myomucosal flaps, conversion Furlow palatoplasty, sphincter pharyngoplasty, and pharyngeal flap are discussed. Selection of an optimal surgical treatment is addressed.

Update on using buccal myomucosal flaps for patients with cleft palate and velopharyngeal insufficiency: primary and secondary interventions.

PURPOSE OF REVIEW: This review aims to examine the indications and anatomical circumstances for when to optimally incorporate buccal myomucosal flaps (BMFs) into palatal surgical reconstruction. RECENT FINDINGS: Studies examining outcomes following primary cleft palate repair with incorporation of BMF have demonstrated excellent speech outcomes and low rates of fistula. Furthermore, some reports cite an association of buccal flap use with reduced midface hypoplasia and the need for later orthognathic surgery. When used for secondary speech surgery, BMFs have been shown to lead to speech improvements across multiple outcome measures. Advantages of BMF techniques over conventionally described pharyngeal flap and pharyngoplasty procedures include significant lengthening of the velum, favorable repositioning of the levator muscular sling, and lower rates of obstructive sleep apnea. SUMMARY: Although the published data demonstrate excellent outcomes with use of BMFs for primary and secondary palatal surgery, there are limited data to conclude superiority over the traditional, more extensively investigated surgical techniques. The authors of this review agree with the evidence that BMF techniques can be useful in primary palatoplasty for congenitally wide clefts, secondary speech surgery for large velopharyngeal gaps, and/or in individuals with a predisposition for airway obstruction from traditional approaches.

Endoscopic lipofilling for velopharyngeal insufficiency after transoral surgery: a technical note.

BACKGROUND: Velopharyngeal insufficiency (VPI) is a known complication of transoral surgery, with a reported incidence of 8.1%. The main factor related to VPI is the split of the soft palate. However, dead space resulting from transoral decompression may play a pivotal role in the pathogenesis of the dysfunction. In our experience, functionally significant dead space is almost constantly present after transoral decompression. This is probably due to malformation in children and postoperative scarring, thus configuring a nosological entity that we could define as "syndrome of the nasopharyngeal dead space." Palatal prosthesis and pharyngoplasty have been proposed, though these surgical procedures are technically tricky and with possible complications, such as OSA symptoms, snoring, and nasopharyngeal stenosis. METHODS: We proposed an effortless and minimally invasive procedure to treat this condition based on lipofilling the nasopharynx posterior wall endoscopically. To test the procedure's functional result, the submucosa of the nasopharynx posterior wall was initially filled with resorbable material, namely fibrin glue and autologous blood. The result was optimal but regressed after one month. Then, we repeated the procedure by lipofilling with autologous abdominal fat, resulting in a more stable anatomical and functional outcome at six months follow-up. RESULTS: The patient had a prompt significant improvement of his complaints (rhinolalia and oronasal regurgitation) and a correct projection of the nasopharynx posterior wall, with correct closure during phonation and absence of oronasal reflux. CONCLUSIONS: The "syndrome of the nasopharyngeal dead space" should be correctly identified after transoral surgery. It can be effectively treated with lipofilling of the posterior nasopharyngeal wall, a simple and minimally invasive procedure.

Impact of anatomical abnormalities on velopharyngeal insufficiency in patients with submucous cleft palate.

BACKGROUND: Submucous cleft palate (SMCP) is a congenital anomaly characterized by the presence of Calnan's triad. However, in clinical practice, it is common for individuals to exhibit one or two anatomical abnormalities within the triad. Furthermore, the definition of SMCP has been diverse and ambiguous in literature. Therefore, this study aimed to analyze the correlation between anatomical abnormalities and development of velopharyngeal insufficiency (VPI). METHODS: We conducted a retrospective analysis of 99 patients referred to our clinic for speech issues or anatomical abnormalities identified during routine oral examinations from January 2012 to June 2023. A single surgeon performed all physical examinations. We evaluated the presence of bony notch, zona pellucida, and bifid uvula, assigned a score to each abnormality, and analyzed their correlation with VPI. The correlation of each of the abnormalities with VPI development was examined, along with the relationship between the number of abnormalities and VPI. RESULTS: Among the 99 patients, 27 were diagnosed with VPI. Only the bony notch had a significant correlation with VPI development. The incidence of VPI tended to increase with the presence of more anatomical abnormalities. VPI occurred in approximately 40% of patients exhibiting all three anatomical abnormalities. CONCLUSION: The study findings highlight the importance of meticulous intraoral examinations in patients with SMCP and careful monitoring of patients with a bony notch or two or more anatomical abnormalities.

Longitudinal Speech and Fistula Outcomes Following Primary Cleft Palate Repair at a Single Institution.

INTRODUCTION: Fistula formation and velopharyngeal insufficiency (VPI) are complications of cleft palate repair that often require surgical correction. The goal of the present study was to examine a single institution's experience with cleft palate repair with respect to fistula formation and need for surgery to correct velopharyngeal dysfunction. METHODS: Institutional review board approval was obtained. Patient demographics and operative details over a 10-year period were collected. Primary outcomes measured were development of fistula and need for surgery to correct VPI. Chi-square tests and independent t tests were utilized to determine significance (0.05). RESULTS: Following exclusion of patients without enough information for analysis, 242 patients were included in the study. Fistulas were reported in 21.5% of patients, and surgery to correct velopharyngeal dysfunction was needed in 10.7% of patients. Two-stage palate repair was associated with need for surgery to correct VPI (P = 0.014). Furlow palatoplasty was associated with decreased rate of fistula formation (P = 0.002) and decreased need for surgery to correct VPI (P = 0.014). CONCLUSION: This study reiterates much of the literature regarding differing cleft palate repair techniques. A 2-stage palate repair is often touted as having less growth restriction, but the present study suggests this may yield an increased need for surgery to correct VPI. Prior studies of Furlow palatoplasty have demonstrated an association with higher rates of fistula formation. The present study demonstrated a decreased rate of fistula formation with the Furlow technique, which may be due to the use of the Children's Hospital of Philadelphia modification. This study suggests clinically superior outcomes of the Furlow palatoplasty over other techniques.

Comparison of modified Furlow palatoplasty using small double-opposing Z-plasty and conventional Furlow palatoplasty: A long-term outcome study.

BACKGROUND: The aim of palatoplasty is to create a functional palate to achieve normal speech, while minimizing post-operative complications. This study aimed to compare the long-term outcomes of modified Furlow palatoplasty using small double-opposing Z-plasty (small-DOZ) and conventional Furlow palatoplasty (conventional-DOZ) performed in a single center. METHODS: A retrospective review of consecutive patients who underwent Furlow palatoplasty between May 2007 and March 2014 was executed. Non-syndromic patients subjected to palatoplasty prior to 24 months of age and followed-up until at least 9 years of age were included. RESULTS: A total of 196 small-DOZ and 280 conventional-DOZ palatoplasty patients were included in this study. Overall, 14 patients (2.9%) developed oronasal fistula, and 40 patients (8.4%) received velopharyngeal insufficiency (VPI) surgery. In comparisons, oronasal fistula rate was significantly higher in conventional-DOZ (0.5% vs. 4.6%, p = 0.01), and the VPI prevalence was not significantly different (9.2% vs. 7.9%, p = 0.62). Patients who developed fistula had a significantly higher likelihood of developing VPI than patients without oronasal fistula (50.0% vs. 7.1%, respectively; p < 0.01), with an odds ratio of 13.0. CONCLUSION: Both modalities of palatoplasty yielded commendable velopharyngeal function in the long-term follow-up. The small-DOZ with reduced tension lowered the risk of oronasal fistula.

Differences in velopharyngeal pressures during speech sound production in patients with unilateral cleft lip and palate (UCLP) and healthy individuals.

Background: During articulation the velopharynx needs to be opened and closed rapidly and a tight closure is needed. Based on the hypothesis that patients with cleft lip and palate (CLP) produce lower pressures in the velopharynx than healthy individuals, this study compared pressure profiles of the velopharyngeal closure during articulation of different sounds between healthy participants and patients with surgically closed unilateral CLP (UCLP) using high resolution manometry (HRM). Materials and methods: Ten healthy adult volunteers (group 1: 20-25.5 years) and ten patients with a non-syndromic surgically reconstructed UCLP (group 2: 19.1-26.9 years) were included in this study. Pressure profiles during the articulation of four sounds (/i:/, /s/, /ʃ/ and /n/) were measured by HRM. Maximum, minimum and average pressures, time intervals as well as detection of a previously described 3-phase-model were compared. Results: Both groups presented with similar pressure curves for each phoneme with regards to the phases described and pressure peaks, but differed in total pressures. An exception was noted for the sound /i:/, where a 3-phase-model could not be seen for most patients with UCLP. Differences in velopharynx pressures of 50% and more were found between the two groups. Maximum and average pressures in the production of the alveolar fricative reached statistical significance. Conclusions: It can be concluded that velopharyngeal pressures of patients with UCLP are not sufficient to eliminate nasal resonance or turbulence during articulation, especially for more complex sounds. These results support a general understanding of hypernasality during speech implying a (relative) velopharyngeal insufficiency.

Effect of palatine tonsil tumor resection on postoperative velopharyngeal insufficiency in transoral surgery.

BACKGROUND: Velopharyngeal insufficiency (VPI) is a known complication of transoral surgery (TOS) for oropharyngeal HPV-mediated squamous cell carcinoma. Controversy exists regarding adequate resection margins for balancing functional and oncologic outcomes. METHODS: This retrospective study was exempted by the IRB. Patients who underwent TOS from January 2017 to October 2022 were included. Patient characteristics, treatment details, and oncologic and functional outcomes were evaluated. RESULTS: Fifty-five patients were included. Mean and median follow-up was 34 months. 98% of patients were AJCC stage I/II. Recurrence-free survival was 96% with no local recurrences. Univariate analysis demonstrated an association between VPI and pT stage (p = 0.035), medial pterygoid resection (p = 0.049), and palatal attachment sacrifice (p < 0.001). Multivariate analysis showed sacrifice of the palatal attachments remained a significant risk for VPI (p = 0.009). CONCLUSION: Loss of soft palate pharyngeal attachments is an independent risk factor for VPI. When oncologically appropriate, the palatal attachments to the pharynx may be preserved.

Speech Outcomes After Palatal Lengthening Via Double Opposing Buccinator Myomucosal Flaps.

BACKGROUND: Palatal lengthening is becoming a first-line treatment choice for cleft patients with velopharyngeal insufficiency (VPI). As cleft palate-related surgical outcomes are age dependent, speech outcomes may be similarly affected by patient age at the time of treatment. The primary goal of this study is to determine whether there are age-related speech outcome differences when double opposing buccinator myomucosal flaps are used as part of a palatal lengthening protocol and whether these outcome differences preclude utilization of this technique for specific patient age groups. METHODS: A retrospective study was performed on consecutive nonsyndromic patients with VPI who underwent treatment using double opposing buccinator myomucosal flaps at our hospital between 2014 and 2021. Patients who completed the 15-month follow-up were stratified by age. Group A aged between 2 and 7 years (n = 14), group B aged 8 and 18 years (n = 23), and group C aged older than 18 years (n = 25) were included. Standardized perceptual speech evaluations and nasopharyngoscopy were performed. Hypernasality, soft palate mobility, and lateral palatal wall mobility were assessed both preoperatively and at a 15-month postoperative interval. Complications were also recorded. The χ2 test was used for statistical comparison. RESULTS: All of the age-stratified patient groups in this study showed significant improvement in hypernasality, soft palate mobility, and lateral wall mobility (P < 0.01), with no statistically significant differences between the different patient age groups. Overall speech success was achieved in 69.4% of patients. Patients in group A achieved 78.6% speech success, patients in group B achieved 78.3% speech success, and patients in group C achieved 56% speech success, with no statistically significant differences being shown regarding speech success between the different patient age groups (P > 0.05). CONCLUSIONS: Regardless of age, palatal lengthening via double opposing buccinator myomucosal flaps similarly improves speech outcomes.

Surgical treatment of velopharyngeal dysfunction: Incidence and associated factors in the Swedish cleft palate population.

INTRODUCTION: Speech in children with cleft palate can be affected by velopharyngeal dysfunction, which persists after primary palate repair. The incidence of surgery to correct velopharyngeal dysfunction in this patient group has previously been reported as 2.6-37%. We aimed to investigate the incidence of velopharyngeal dysfunction surgery in Swedish children with cleft palate and to examine potential associations of independent variables with this incidence. METHODS: In this cohort study, we analysed data from the Swedish cleft lip and palate quality registry for 1093 children with cleft palate with or without cleft lip. Kaplan-Meier analysis was used to estimate the risk of having velopharyngeal dysfunction surgery. Multivariable Cox proportional hazards models were used to estimate the associated effect of cleft subtype, additional diagnoses, gender, and age at and number of stages for primary palate repair on the primary outcome. RESULTS: The risk of having velopharyngeal dysfunction surgery was 25.6%. Complete primary palate repair after the age of 18 months or in more than one stage was associated with a higher risk, but it could not be determined which of these was the more significant factor. Cleft soft palate was associated with a significantly lower risk than other cleft subtypes. CONCLUSIONS: Primary palate repair at a higher age or in more than one stage may increase the risk of having velopharyngeal dysfunction surgery. Further analysis of potential unknown confounding factors and the association between the incidence of velopharyngeal dysfunction and surgery to correct this condition is needed.

Long-term outcomes of sphincter pharyngoplasty in patients with cleft palate.

OBJECTIVE: The purpose of this study was to evaluate long-term outcomes of sphincter pharyngoplasties, including speech outcomes, revision surgeries, and postoperative incidence of obstructive sleep apnea (OSA). DESIGN: Retrospective matched-cohort study SETTING: Two craniofacial centers in Los Angeles, CA PATIENTS: Patients (n = 166) with cleft lip and palate (CLP) or isolated cleft palate (iCP) who underwent sphincter pharyngoplasty from 1992 to 2022 were identified. An age- and diagnosis-matched control group of 67 patients with CLP/iCP without velopharyngeal insufficiency (VPI) was also identified. INTERVENTIONS: The pharyngoplasty group underwent sphincter pharyngoplasty, whereas the non-VPI group had no history of VPI surgery or sphincter pharyngoplasty. MAIN OUTCOME MEASURES: Postoperative speech outcomes, revision surgeries, and incidence of OSA were evaluated. Multivariable regression was used to evaluate independent predictors of OSA. RESULTS: Among the patients in the pharyngoplasty cohort, 63.9% demonstrated improved and sustained speech outcomes after a single pharyngoplasty, with a median postoperative follow-up of 8.8 years (interquartile range [IQR], 3.6-12.0 years). One-third of the patients who underwent pharyngoplasty required a revision surgery, with a median time to primary revision of 3.9 years (IQR, 1.9-7.0 years). OSA rates increased significantly among the pharyngoplasty cohort, from 3% before surgery to 14.5% after surgery (p < 0.001). The average time from sphincter pharyngoplasty to OSA diagnosis was 4.4 ± 2.4 years. Multivariable analysis results indicated that sphincter pharyngoplasty surgery was independently associated with a fourfold increase in OSA (p = 0.03). CONCLUSIONS: Although sphincter pharyngoplasty remains successful in improving long-term speech outcomes, persistent OSA is a sequela that should be monitored beyond the immediate postoperative period.

Pharyngeal flap outcomes for velopharyngeal insufficiency: Evaluation of speech, obstructive sleep apnea, and velopharyngeal anatomy.

The purpose of this study was to evaluate the speech outcomes, reveal postoperative rates of obstructive sleep apnea, and characterize changes in the pharyngeal flap and velopharyngeal anatomy following pharyngeal flap surgery for velopharyngeal insufficiency. A retrospective chart was reviewed for patients with clefts who underwent pharyngeal flap surgery between November 2020 and November 2021. The data collected included age, gender, cleft palate type, age at pharyngeal flap surgery, postoperative complications, age and type of primary palatoplasty, preoperative and postoperative speech assessments, magnetic resonance imaging findings, and obstructive sleep apnea outcomes. The authors included 72 nonsyndromic patients who underwent pharyngeal flap surgery following cleft palate repair. The mean age at pharyngeal flap surgery was 10.6 ± 6.2 years. There was a significant improvement in the Pittsburgh Weighted Speech Score Hypernasality Component and the nasalance scores of oral syllables (p < 0.001). The obstructive sleep apnea rate after pharyngeal flap surgery was 6.9%. Compared to preoperatively, the velar angle was more acute (p < 0.001), the velar length was longer (p < 0.001), the distance of the velum tip to the posterior pharyngeal wall was shorter (p < 0.001), the size of velopharyngeal gap was narrower (p < 0.001), and the pharyngeal flap atrophied (p < 0.001) at 6 months postoperatively. The pharyngeal flap improved speech outcomes in patients with velopharyngeal insufficiency with a relatively low incidence of obstructive sleep apnea (6.9%). The velum is positioned more superiorly and posteriorly, and the size of the velopharyngeal gap is substantially reduced after pharyngeal flap surgery. In addition, the pharyngeal flap partially atrophied over time.

Bilateral Buccal Flap Revision Palatoplasty to Correct Velopharyngeal Dysfunction: Perceptual Speech, Acoustic, and Aerodynamic Outcomes.

BACKGROUND: The purpose of this study was to analyze perceptual, acoustic, and aerodynamic changes in speech and velopharyngeal function after bilateral buccal flap revision palatoplasty (BBFRP) in patients with repaired cleft palate. METHODS: Ten consecutive patients ages 4 to 18 years with velopharyngeal dysfunction treated with BBFRP by a single surgeon were evaluated. Using a visual analog scale, nine blinded speech-language pathologists independently rated hypernasality, hyponasality, audible nasal emission, and speech acceptability. Measurements of the acoustic speech signal were used to quantify changes in hypernasality and nasal emission. The pressure flow technique was used to determine changes in velopharyngeal gap size. RESULTS: Complete records were available for eight patients. After surgery, hypernasality decreased ( P < 0.001) and speech acceptability increased ( P < 0.001) significantly. Audible nasal emission was significantly reduced ( P < 0.001). Postoperative acoustic measures showed a reduction of nasal emission and nasalization. Velopharyngeal gap size significantly decreased after BBFRP ( P < 0.001), correlating with lower visual analog scale ratings of hypernasality ( P = 0.015). Hyponasality did not change significantly after surgery ( P = 0.964). No patient developed sleep-disordered breathing. CONCLUSION: BBFRP resulted in a measurable improvement in hypernasal speech, audible nasal emission, and speech acceptability without significant changes in hyponasality or risk of obstructive sleep apnea. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Treatment of Velopharyngeal Insufficiency Using Bilateral Myomucosal Buccinator Flaps.

SUMMARY: The buccinator myomucosal flap, also referred to as a buccal myomucosal flap, is an effective technique to address velopharyngeal insufficiency after cleft palate repair. Challenges related to flap harvesting may deter plastic surgeons from incorporating this strategy as a first-line treatment. The primary objective of this study and accompanying video is to provide support regarding indications, planning, and surgical steps of the buccinator myomucosal flap technique, including important technical details for soft-palate dissection and flap harvesting.

Do Buccal Flaps Improve Velopharyngeal Insufficiency in Conversion Furlow Palatoplasty for Patients with Cleft Palate?

SUMMARY: Velopharyngeal insufficiency (VPI) is a complication following primary palatoplasty that can lead to hypernasality of the voice and other speech problems. The conversion Furlow palatoplasty for VPI can be performed with the addition of buccal flaps to provide additional tissue for palatal repair. In this study, the authors aimed to determine the effectiveness of buccal flaps with conversion Furlow palatoplasty in secondary management of VPI. A retrospective review of patients undergoing surgical repair of VPI between 2016 and 2020 was performed. Patients underwent either conversion Furlow palatoplasty alone (FA) or conversion Furlow palatoplasty with buccal flaps (FB) for VPI after primary straight-line repair of the palate. The authors reviewed medical records to collect demographics, operative information, and preoperative and postoperative speech scores. Of the 77 patients in the study, 16 (21%) had a revision that incorporated buccal flaps. The median age at cleft palate revision surgery was 8.97 years in the FA group and 7.96 years in the FB group ( P = 0.337). In the FA group, four patients (7%) developed a postoperative fistula, compared with zero patients in the FB group. The average time to follow-up after revision surgery was 3.4 years (range, 7 months to 5.9 years). Both cohorts demonstrated a decrease in hypernasality and total parameter scores postoperatively. The use of buccal flaps in revision Furlow palatoplasty could decrease the risk for postoperative complications. The use of data from a larger patient population from multiple institutions is warranted to determine true significance. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Proposed clinical model for predicting speech outcomes in patients undergoing Furlow palatoplasty for velopharyngeal insufficiency after primary palatoplasty.

This study aimed to validate the predictors of speech outcomes following Furlow palatoplasty in patients with velopharyngeal insufficiency (VPI) after primary palatoplasty and to propose and validate a model to predict the risk of persistent VPI. The study included patients with VPI after primary palatoplasty who underwent Furlow palatoplasty as a secondary surgery. Eleven variables were included: velar length, pharyngeal cavity depth, velopharyngeal gap, velopharyngeal closure pattern, sex, presence of cleft lip, existence of palatal fistula, surgeon, age at primary palatoplasty, age at secondary surgery, and time interval between primary palatoplasty and secondary surgery. Postoperative speech outcomes were assessed at least 1 year after the secondary surgery and classified as velopharyngeal competence (VPC) or VPI. Variables were analyzed using multivariate logistic regression analysis, and the area under the curve (AUC) was used to validate model accuracy. The study sample comprised 101 patients. Of the patients, 62 had VPC and 39 had VPI after secondary surgery. The results showed a younger age at secondary surgery, a smaller velopharyngeal gap, being female, having a coronal velopharyngeal closure pattern and a velopharyngeal closure ratio of 90% or greater produced a greater probability of VPC. Given the constraints of this study, it appears that the Furlow palatoplasty should be prioritized when the clinical model predicts a substantial likelihood of VPC post-surgery.

Impact of a Palatal Fistula After Cleft Palate Repair on Velopharyngeal Closure.

PURPOSE: A palatal fistula is an adverse outcome of cleft palate repair. It is unknown if a palatal fistula will influence velopharyngeal closure, even after repair of the fistula. This study determines the effect of a soft palate fistula on the risk of developing velopharyngeal insufficiency. METHODS: A retrospective chart review was conducted on patients who underwent primary cleft palate repair between 2000 and 2015, with complete records at 4 years of age. Fistulae involving the secondary palate following primary palatoplasty were classified as the soft or hard palate. A forced-entry multivariate logistic regression model was built to detect predictors of velopharyngeal dysfunction. RESULTS: Records of 329 patients were analyzed with a mean follow-up of 8.7 years. A palatal fistula was identified in 89/329 patients (27%) and 29/329 patients (9%) underwent an independent fistula repair. Of the patients with fistula, 44% were located in the hard palate only and 56% had soft palate involvement. Compared to patients without a fistula, rates of velopharyngeal dysfunction were significantly higher in patients with a fistula involving the soft palate (OR 3.875, CI: 1.964-7.648, P < .001) but not in patients with a hard palate fistula (OR 1.140, CI: 0.497-2.613, P = .757). Veau class, age at primary repair, and syndromic status were not significant predictors of VPI (0.128≤P ≤ .975). CONCLUSIONS: A palatal fistula involving the soft palate is a significant predictor for development of velopharyngeal dysfunction after primary palatoplasty. Surgical intervention, at the time of fistula repair, to add vascularized tissue may be indicated to prophylactically decrease the risk of velopharyngeal dysfunction.

Speech correcting surgery after primary palatoplasty: a systematic literature review and meta-analysis.

OBJECTIVES: In cleft palate patients, the soft palate is commonly closed using straight-line palatoplasty, Z-palatoplasty, or palatoplasty with buccal flaps. Currently, it is unknown which surgical technique is superior regarding speech outcomes. The aim of this review is to study the incidence of speech correcting surgery (SCS) per soft palatoplasty technique and to identify variables which are associated with this outcome. MATERIALS AND METHODS: A systematic literature search was carried out according to the PRISMA guidelines. Inclusion and exclusion criteria were applied to focus on the incidence of SCS after soft palatoplasty. Additional variables like surgical modification, cleft morphology, syndrome, age at palatoplasty, fistula and assessment of velopharyngeal function were reported. A modified New-Ottawa Scale (NOS) was used for quality appraisal. Pooled estimates from the meta-analysis were calculated using a random-effects model. RESULTS: One thousand twenty-nine studies were found of which 54 were included in the analysis. The pooled estimate proportion of SCS after straight-line palatoplasty was 19% (95% CI 15-24), after Z-palatoplasty 6% (95% CI 4-9), and after palatoplasty with buccal flaps 7% (95% CI 4-11). CONCLUSIONS: A lower SCS rate was found in patients receiving Z-palatoplasty when compared to straight-line palatoplasty. We propose a minimum set of outcome parameters which ideally should be included in future studies regarding speech outcomes after cleft palate repair. CLINICAL RELEVANCE: Current literature reports highly heterogenous data regarding cleft palate repair. Our recommended set of parameters may address this inconsistency and could make intercenter comparison possible and of better quality.

Timing of Primary Surgery for Cleft Palate.

BACKGROUND: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. METHODS: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESULTS: We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up. CONCLUSIONS: Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).