scholarly journals On randomised trials of surgical timings for cleft palate repair

2021 ◽  
Vol 4 (2) ◽  
Author(s):  
Selena Young ◽  
Seng Teik Lee ◽  
David Machin ◽  
Say Beng Tan ◽  
Qingshu Lu

Background: In this article we review randomised controlled trials (RCTs) comparing palatal surgery at different ages to examine their design features and quantify their conclusions. Method: A literature search of RCTs comparing surgical timings for cleft palate and/or lip repair from 1 January 2004 to 31 December 2013 was undertaken. This supplements an earlier systematic review of 62 RCTs in cleft lip and palate from 1 January 2004 to 31 December 2013 in English using the Cochrane Central Register of Controlled Trials, MEDLINE® and EMBASE with key words ‘cleft lip’ or ‘cleft palate’. Results: Four RCTs were identified, each comparing palate surgery at different lower (six, nine and 12 months) and upper (12, 18 and 36 months) ages with velopharyngeal competence (VPC) also at different ages (three, four, more than four or five years). These surgical and assessment age differences prevent a synthesis using meta-analysis techniques. Nevertheless, three RCTs indicate that VP function is more impaired with later surgery. Two ask questions about the type of surgery; one suggests that VPC is greater with Furlow palatoplasty than von Langenbeck surgery and the other that one technique appears to have better VPC at six months and the other at 12 months. Conclusion: The role of the timing of palatal surgery with respect to VPC remains unclear. We propose an international strategy that is designed to establish the optimal age for palatal surgery in infants requiring palate and/or lip repair.

2021 ◽  
Author(s):  
Andres Campolo ◽  
Claudia Heider ◽  
Ismael Canete ◽  
Francisca Verdugo ◽  
Rocio Bravo ◽  
...  

Objective: To assess the effectiveness and safety of autologous platelet derivatives, specifically platelet-rich plasma (PRP) or platelet-rich fibrin (PRF), for secondary alveoloplasty in patients with cleft lip and palate. Eligibility criteria: We will include randomized trials evaluating the effect of autologous platelet derivatives on newly bone formed after secondary alveoloplasty in cleft lip and palate patients. Two reviewers will independently screen each study for eligibility, data extraction, and bias assessment using the Cochrane "risk of bias" tool. We will pool the results using meta-analysis and apply the GRADE system to assess the certainty of the evidence for each outcome. Data sources: A comprehensive search will include all relevant randomized controlled trials (RCTs), the ongoing investigation reported in specialty congresses and trials regardless of language or publication status (published, unpublished, in press, and progress). We will conduct searches in the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), PUBMED, Embase, and LILACS. We will screen trial registries and other sources in order to identify articles that might have been missed in the electronic searches. Ethics and dissemination: As researchers will not access information that could identify an individual participant, obtaining ethical approval was waived. Keywords: Platelet-rich fibrin; Platelet-rich plasma; Secondary alveoloplasty; Cleft lip; cleft palate; Alveolar Bone Grafting; Systematic review, protocol, meta-analysis


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kristina Klintö ◽  
Maria Sporre ◽  
Magnus Becker

Abstract Background When evaluating speech in children with cleft palate with or without cleft lip (CP/L), children with known syndromes and/or additional malformations (CP/L+) are usually excluded. The aim of this study was to present speech outcome of a consecutive series of 5-year-olds born with CP/L, and to compare speech results of children with CP/L + and children with CP/L without known syndromes and/or additional malformations (CP/L-). Methods One hundred 5-year-olds (20 with CP/L+; 80 with CP/L-) participated. All children were treated with primary palatal surgery in one stage with the same procedure for muscle reconstruction. Three independent judges performed phonetic transcriptions and rated perceived velopharyngeal competence from audio recordings. Based on phonetic transcriptions, percent consonants correct (PCC) and percent non-oral errors were investigated. Group comparisons were performed. Results In the total group, mean PCC was 88.2 and mean percent non-oral errors 1.5. The group with bilateral cleft lip and palate (BCLP) had poorer results on both measures compared to groups with other cleft types. The average results of PCC and percent non-oral errors in the CP/L + group indicated somewhat poorer speech, but no significant differences were observed. In the CP/L + group, 25 % were judged as having incompetent velopharyngeal competence, compared to 15 % in the CP/L- group. Conclusions The results indicated relatively good speech compared to speech of children with CP/L in previous studies. Speech was poorer in many children with more extensive clefts. No significant differences in speech outcomes were observed between CP/L + and CP/L- groups.


2018 ◽  
Vol 55 (10) ◽  
pp. 1399-1408 ◽  
Author(s):  
Kristina Klintö ◽  
Evelina Falk ◽  
Sara Wilhelmsson ◽  
Björn Schönmeyr ◽  
Magnus Becker

Objective: To evaluate speech in 5-year-olds with cleft palate with or without cleft lip (CP±L) treated with primary palatal surgery in 1 stage with muscle reconstruction according to Sommerlad at about 12 months of age. Design: Retrospective study. Setting: Primary care university hospital. Participants: Eight 5-year-olds with cleft soft palate (SP), 22 with cleft soft/hard palate (SHP), 33 with unilateral cleft lip and palate, and 17 with bilateral CLP (BCLP). Main Outcome Measures: Percent oral consonants correct (POCC), percent consonants correct adjusted for age (PCC-A), percent oral errors, percent nonoral errors, and variables related to velopharyngeal function were analyzed from assessments of audio recordings by 3 independent speech-language pathologists. Results: The median POCC was 75.4% (range: 22.7%-98.9%), median PCC-A 96.9% (range: 36.9%-100%), median percent oral errors 3.4% (range: 0%-40.7%), and median percent nonoral errors 0% (range: 0%-20%), with significantly poorer results in children with more extensive clefts. The SP group had significantly less occurrence of audible nasal air leakage than the SHP and the BCLP groups. Before age 5 years, 1.3% of the children underwent fistula surgery and 6.3% secondary speech improving surgery. At age 5 years, 15% of the total group was perceived as having incompetent velopharyngeal function. Conclusions: Speech was poorer in many children with more extensive clefts. Children with CP±L had poorer speech compared to normative data of peers without CP±L, but the results indicated relatively good speech compared to speech of children with CP±L in previous studies.


Author(s):  
Lalit Kochar ◽  
Deepak V. Chauhan ◽  
S. P. Bajaj ◽  
Akash Juneja

<p class="abstract"><strong>Background:</strong> Isolated cleft palate and cleft palate and cleft lip patients have poor Eustachian tube function which results in hearing impairment that too in the speech formative years. Aim of study was to evaluate tympanometric findings in patient of cleft palate and effect of palatoplasty on both short term and long term postoperatively.</p><p class="abstract"><strong>Methods:</strong> The subjects consisted of patients attending the cleft lip and palate clinic. This was a combined clinic consisting of department of plastic surgery, department of ENT and department of dental surgery held every month at a tertiary care hospital in Delhi. Study consisted of three groups of patients namely preoperative group, postoperative group and pre-postoperative group.</p><p class="abstract"><strong>Results:</strong> No significant difference was observed in tympanometric abnormalities in cases of combined cleft lip and palate as compared to isolated cleft palate. After age of 5 months once changes of OME has set in there was no significant change in middle ear findings irrespective of palatal repair.</p><p class="abstract"><strong>Conclusions:</strong> There is a very high prevalence of otitis media with effusion in these patients. The changes do resolve spontaneously after age of seven, this perhaps is due to combined effect, growth, development and l maturity of Eustachian tube and palatal surgery rather than palatal surgery alone.</p><p> </p>


1998 ◽  
Vol 21 (2) ◽  
pp. 259-262 ◽  
Author(s):  
N.M. Kokitsu-Nakata ◽  
A. Richieri-Costa

We have evaluated a girl and a boy with the blepharophimosis, ptosis and epicanthus inversus syndrome (BPES). The girl presented cleft palate and the boy showed cleft lip and palate as additional clinical signs. Both showed familial recurrence in fourth and third generations, respectively. The other family members also presented blepharophimosis, ptosis, and epicanthus inversus, but without lip and palatal involvement. There were no additional clinical signs nor infertility in these patients. To our knowledge this is the first instance of cleft lip and palate reported as additional signs of the BPES syndrome.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9561-9561
Author(s):  
Hussein Abdul-Hassan Tawbi ◽  
Georgina V. Long ◽  
Nicolas Meyer ◽  
Boris Breznen ◽  
Charmy Vyas ◽  
...  

9561 Background: The introduction of immunotherapy and targeted therapy has revolutionized the treatment landscape for metastatic melanoma. However, clinical trial data in pts with MBM are scarce; here we summarize the available clinical evidence. Methods: An SLR was conducted by searching EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials databases through November 13, 2020. When available, Kaplan-Meier (K-M) curves for overall survival (OS) were digitized and converted to pseudo-individual pt data using the Guyot algorithm. A meta-analysis of the pooled K-M curves was performed for selected interventions, including immunotherapies and targeted therapies. Median OS was calculated either through the meta-analysis of K-M curves or as a weighted average of median OS (table). When interventions were reported in only 1 study, the value reported was used instead of the weighted average and compared qualitatively with the other results. Results for treatment modalities other than systemic agents will also be presented. Results: The SLR included 70 publications that evaluated systemic therapies in pts with MBM for qualitative evidence synthesis: 12 pertaining to 7 randomized controlled trials, 55 pertaining to 46 single-arm studies, and 3 involving nonrandomized comparative studies. The pt population was highly heterogeneous with respect to prior therapies, pt characteristics, and neurological symptoms. For the meta-analysis, a total of 25 K-M curves from 12 studies representing 6 interventions and 1043 pts were digitized. Based on the pooled K-M curves, median OS was numerically longer with nivolumab plus ipilimumab (NIVO + IPI; 28.3 mo; 95% CI, 19.7-31.9) than with the other interventions (range 5.7-11.8 mo; table). Similar OS benefit was also observed with NIVO + IPI when the weighted average of the median was used (in a long-term study, median OS was 29.2 mo) compared with the other interventions. Conclusions: Given the lack of comparative clinical trial data in pts with MBM, there remains an unmet need to determine the best approach to treat these pts. This analysis suggested a clinical advantage with NIVO + IPI compared with other systemic agents analyzed. The heterogeneity of the available data added uncertainty to our treatment assessments. Therefore, these findings warrant further research into the best approach to improve outcomes in pts with MBM.[Table: see text]


1999 ◽  
Vol 36 (5) ◽  
pp. 413-424 ◽  
Author(s):  
Samuel Berkowitz

Objective: To compare the multicenter retrospective and prospective spaciotemporal (4D) serial analyses of complete unilateral (CUCLP) and complete bilateral (CBCLP) cleft lip and palate casts that had undergone different treatment procedures. The involved institutions are Miami Craniofacial Anomalies Foundation, South Florida Cleft Palate Clinic; University Hospital of Nijmegen Cleft Palate Center; Free University of Amsterdam Cleft Palate Center; Academic Hospital (Dijkzigt/Sophia) Rotterdam Cleft Palate Center; Center for Craniofacial Anomalies, University of Illinois College of Medicine; Cleft Palate Center, Sahigrenska University Hospital, Göteborg, Sweden; and Children's Memorial Medical Center, Northwestern University Cleft Palate Institute. Design: Using serial casts of the upper jaw and an electromechanical digitizer with special CadCam software (CadKey), the occlusal relationships and morphometric palatal growth changes that occur under the influence of presurgical orthopedics and various surgical procedures will be studied. It is anticipated that 3D geometric data extracted from serial casts will identify the important geometric palatal parameters present before cleft surgical closure, which will supply objective criteria for establishing a scientific basis for improved surgical therapy. This research study will test three hypotheses: (1) Conservative (varying the timing of surgical cleft closure according to the size of the cleft space) lip and palatal surgery will permit “catch-up” palatal growth and normalize palatal growth and development. (2) The amount of mucoperiosteal tissue relative to the size of the cleft space is important in determining the timing of palatal surgery, as it influences the degree of scarring and ultimately the palate's adult size and form. (3) Presurgical orthopedics (the use of appliances soon after birth) can stimulate palatal growth beyond its normal growth potential. Results: In a previous project and again after reviewing the data already collected during the first year of this study, it has been shown that incremental changes in size of palatal segments in CUCLP and CBCLP cases prior to surgery vary slightly. The CBCLP cases grow slightly faster than CUCLP cases before surgery, but growth of the CBCLP cases decreases in acceleration after surgery. Reasons for these differences will be determined when more cases are analyzed and subjected to biostatistical analysis.


2000 ◽  
Vol 37 (2) ◽  
pp. 172-178 ◽  
Author(s):  
Elisabeth Willadsen ◽  
Hans Enemark

Objective This study examined the prelinguistic contoid (consonant-like) inventories of 14 children with unilateral cleft lip and palate (C-UCLP) at 13 months of age. The children had received primary veloplasty at 7 months of age and closure of the hard palate was performed at 3–5 years. The results of this investigation were compared to results previously reported for 19 children with cleft palate and 19 noncleft children at the age of 13 months. The children with clefts in that study received a two-stage palatal surgery. This surgical procedure was formerly used at our center and included closure of the lip and hard palate at 3 months of age and soft palate closure at 22 months of age. Design Retrospective study. Setting The participants were videorecorded in their homes during play with their mothers. The videotapes were transcribed independently by three trained speech pathologists. Patients Fourteen consecutive patients born with C-UCLP and no known mental retardation or associated syndromes served as subjects. Results The children who received delayed closure of the hard palate demonstrated a significantly richer variety of contoids in their prespeech vocalizations than the cleft children in the comparison group. Both groups of subjects with clefts had significantly fewer plosives in their contoid inventory than the noncleft group, and there was no difference regarding place of articulation between the group that received delayed closure of the hard palate and the noncleft group.


2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Seunghee Ha ◽  
Kyung S. Koh ◽  
Heewon Moon ◽  
Seungeun Jung ◽  
Tae Suk Oh

This study presents clinical outcomes of primary cleft palate surgery, including rate of oronasal fistula development, rate of velopharyngeal insufficiency (VPI) requiring secondary surgery, and speech outcomes. We examined the effect of cleft type on the clinical outcomes. Retrospective analysis was performed using clinical records of all patients who received a primary palatoplasty at the Cleft Palate Clinic at Seoul Asan Medical Center, South Korea, between 2007 and 2012. The study included 292 patients with nonsyndromic overt cleft palate (±cleft lip). The results revealed that the rate of oronasal fistula was 7.9% and the incidence of VPI based on the rate of secondary palatal surgery was 19.2%. The results showed that 50.3% of all the patients had received speech therapy and 28.8% and 51.4% demonstrated significant hypernasality and articulatory deficits, respectively. The results of the rate of VPI and speech outcomes were significantly different in terms of cleft type. Except for the rate of oronasal fistula, patients with cleft palate generally exhibited better clinical outcomes compared to those with bilateral or unilateral cleft lip and palate. This study suggests that several factors, including cleft type, should be identified and comprehensively considered to establish an optimal treatment regimen for patients with cleft palate.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lajos Szakó ◽  
Nelli Farkas ◽  
Szabolcs Kiss ◽  
Szilárd Váncsa ◽  
Noémi Zádori ◽  
...  

Abstract Background Coronavirus disease 2019 (COVID-19) is an infection with possible serious consequences. The plasma of recovered patients might serve as treatment, which we aim to assess in the form of a prospective meta-analysis focusing on mortality, multi-organ failure, duration of intensive care unit stay, and adverse events. Methods A systematic search was conducted to find relevant registered randomized controlled trials in five trial registries. A comprehensive search will be done continuously on a monthly basis in MEDLINE (via PubMed), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science to find the results of previously registered randomized controlled trials. The selection will be done by two independent authors. Data extraction will be carried out by two other independent reviewers. Disagreements will be resolved by a third investigator. An update of the search of the registries and the first search of the databases will be done on the 21st of July. Data synthesis will be performed following the recommendations of the Cochrane Collaboration. In the case of dichotomous outcomes (mortality and organ failure), we will calculate pooled risk ratios with a 95% confidence interval (CI) from two-by-two tables (treatment Y/N, outcome Y/N). Data from models with multivariate adjustment (hazard ratios, odds ratio, risk ratio) will be preferred for the analysis. P less than 0.05 will be considered statistically significant. In the case of ICU stay, weighted mean difference with a 95% confidence interval will be calculated. Heterogeneity will be tested with I2, and χ2 tests. Meta-analysis will be performed if at least 3 studies report on the same outcome and population. Discussion Convalescent plasma therapy is a considerable alternative in COVID-19, which we aim to investigate in a prospective meta-analysis.


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