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A prospective, randomized, blinded trial in cleft surgery training: Textbook vs digital simulation [Meeting Abstract]

Diaz-Siso, J R; Kantar, R; Rifkin, W; Plana, N; David, J; Maliha, S; Flores, R
Background/Purpose: Surgical education is increasingly relying on digital and online resources. However, the educational benefit of learning through digital media has not been rigorously tested in the field of cleft care. We present a prospective, randomized, blinded trial comparing the educational efficacy of a textbook vs digital simulation in teaching cleft lip repair. Methods/Description: Medical student volunteers (N = 35) were asked to draw a cleft lip repair on a standardized patient photograph of a complete unilateral cleft lip deformity (Pretest). They were then randomized to 1 of 2 study groups that demonstrated unilateral cleft lip repair markings: textbook (n = 17) or digital simulation (n = 18). After 20 minutes of study, volunteers were asked to draw a cleft lip repair a second time on the same standardized photograph (Posttest). Volunteers were then shown the educational material provided to the other study group and given a validated survey to compare the educational value of both resources. Cleft lip marking was graded in a blinded manner on 2 separate occasions using a 0-to 10-point scale created by 2 senior cleft surgeons. Paired and independent t tests were used to compare differences between groups. Intrarater reliability was evaluated using intraclass correlation coefficients (ICCs).
Result(s): Intrarater reliability was excellent for both pretest (ICC = 0.94; P < .001) and posttest (ICC = 0.95; P < .001) grading. Pretest performances between the textbook and simulator groups were comparable (0.82 +/-1.17 vs 0.64+/-0.95; P = .31). There was significant improvement in posttest performance compared to pretest in both the textbook (3.50 +/- 1.62 vs 0.82 +/- 1.17; P < .001) and simulator (6.44 +/- 2.03 vs 0.64 +/- 0.95; P < .001) groups. However, significantly greater improvement was demonstrated by the simulator group when compared to the textbook group (5.81 +/- 2.01 vs 2.68 +/- 1.49; P < .001). Participants thought the simulator increased interest (3.91 +/- 1.01 vs 2.31+/-1.21; P < .001); allowed learning (3.83+/-0.95 vs 2.17 +/-1.20; P < .001); was stimulating (3.74+/-0.98 vs 1.69+/-0.87; P < .001), clearer (3.66+/-1.08 vs 2.17+/-1.22; P < .001), and effective in teaching (4.14 +/- 0.94 vs 2.31 +/- 1.21; P < .001); and that they were likely to be recommended to others (4.00+/-1.11 vs 2.14+/-1.19; P < .001) more than the textbook.
Conclusion(s): A prospective, randomized, blinded study demonstrates superior cleft lip repair learning through digital simulation compared to textbook. Learners subjectively found digital simulation to be the superior educational medium. The cleft and craniofacial society should strongly consider investment into digital media platforms to teach future cleft surgeons
EMBASE:629011403
ISSN: 1545-1569
CID: 4051392

Challenging convention: assessment of perioperative complications associated with outpatient primary cleft palate surgery [Meeting Abstract]

Kantar, R; Cammarata, M; Rifkin, W; Plana, N; Diaz-Siso, J R; Flores, R
Background/Purpose: Outpatient primary cleft palate surgery (PCPS) has been implemented in many cleft centers; however, the prevalence of this procedure is unknown and its safety has been called into question. We queried the American College of Surgeons National Surgical Quality Improvement Program Pediatric database (ACS NSQIPPediatric) to evaluate perioperative complications associated with PCPS. Methods/Description: The ACS NSQIP-Pediatric database was reviewed from 2012 to 2015 using Current Procedure Terminology (CPT) codes for PCPS. Patients undergoing concurrent bone grafting or cleft lip surgery were excluded. Patients aged 5 years or younger were included. The goal of our study was to compare 30-day perioperative complications following outpatient vs inpatient PCPS. Statistical analyses were carried out using SPSS (Version 21.0. Armonk, NY: IBM Corp).
Result(s): We identified 4191 (2760 inpatient vs 1431 outpatient) eligible patients. The majority of patients were males (52.6%). Plastic surgeons performed these procedures most frequently (80.3%) followed by otolaryngologists (18.7%). Tympanostomy tube insertion was the most common concurrent procedure (17.1%). Mean age in days and weight in kilograms at surgery were 485.5 +/- 319.2 and 9.7 +/- 3.8, respectively. Mean age (509.3 +/- 346.9 vs 473.2 +/- 303.1; P < .001) and weight (9.9 +/- 4.0 vs 9.6 +/- 3.8; P = .01) were significantly higher in the outpatient group. The inpatient group included a significantly higher proportion of patients with congenital abnormalities (25.0% vs 21.2%; P = .01), history of stroke (1.0% vs 0.3%; P = .02), cardiac risk factors (14.4% vs 11.7%; P = .02) and oxygen dependence (1.8%vs 0.8%; P = .01). Univariate analysis showed that rates of superficial (3.5% vs 2.0%; P = .01) and deep (2.2% vs 1.0%; P = .003) wound dehiscence were significantly higher in the outpatient group. The rates of reoperation (1.2 vs 0.4; P = .02) and readmission (3.2 vs 1.5; P = .01) were significantly higher in the inpatient group. Mortality at 30 days was comparable between groups. After controlling for confounders, rates of superficial (OR = 1.99, P = .01, 95% CI [1.22, 3.24]) and deep (OR = 2.22, P = .01, 95% CI [1.25, 3.95]) wound dehiscence remained significantly higher in the outpatient group, whereas reoperation (OR = 2.8, P=.04, 95%CI [1.04, 7.14]) and readmission (OR=1.92, P= .02, 95% CI [1.14, 3.23]) rates were significantly higher in the inpatient group.
Conclusion(s): Outpatient PCPS is a common practice and appears to have an acceptable safety profile in appropriately selected patients. Outpatient surgery has a higher risk for wound complications. Inpatient surgery is associated with greater reoperation and readmission. Preoperative evaluation of patient risk factors and comorbidities is critical for optimal outcomes
EMBASE:629010838
ISSN: 1545-1569
CID: 4051402

Nasoalveolar molding in patients with bilateral clefts of the lip, alveolus, and palate [Meeting Abstract]

Shetye, P; Flores, R
Background/Purpose: Presurgical infant orthopedics has been employed since 1950 as an adjunctive neonatal therapy for the correction of cleft lip and palate. Most of these therapies did not address deformity of the nasal cartilage in unilateral and bilateral cleft lip and palate as well as the deficiency of the columella tissue in infants with a bilateral cleft. The nasoalveolar molding (NAM) technique is a unique approach to presurgical infant orthopedics to reduce the severity of the initial cleft of the alveolar and the nasal deformity, particularly in patients with bilateral cleft lip and palate. Methods/Description: In infants with bilateral cleft lip and palate, the premaxilla may be protrusive, mobile, and may show varying degree of asymmetrical displacement and rotation. In some instances, the premaxilla may be everted placed on top of the nasal tip with a very short columella length. Protruded premaxilla and the associated nasal deformity present a special challenge for the surgeon in achieving optimal repair during primary reconstructive surgery. This study session will demonstrate the NAM technique to treat patients with severe bilateral cleft lip and palate. The technique of correcting the protruded and asymmetrically displaced premaxilla, molding the alar cartilage and nonsurgical columella elongation will be discussed. Appliance design and weekly adjustment of the NAM appliance to accomplish the desired result will be presented. Special emphasis will be placed on leveling the premaxilla in asymmetric cases; retracting premaxilla in incomplete bilateral clefts and management of complications during the course of the NAM therapy will be discussed. For the successful outcome, the surgeon has to take the advantage of the NAM therapy during the primary repair. Surgical technique of 1-stage lip nose and alveolus surgery utilizing the presurgical preparation of infants with bilateral cleft lip and palate with NAM therapy will be discussed in detail. Long-term outcome of patients treated with NAM and primary reconstruction of nose lip and alveolus will be presented
EMBASE:629010833
ISSN: 1545-1569
CID: 4051422

Effects of alveolar cleft management on permanent canine position and eruption: comparing gingivoperiosteoplasty and secondary alveolar bone grafting [Meeting Abstract]

Gibson, T; Grayson, B; Flores, R; Shetye, P
Background/Purpose: Gingivoperiosteoplasty (GPP) performed concurrent with lip repair is an option for treating bony alveolar deficiency in patients with orofacial clefts. GPP has been demonstrated to produce bony continuity, eliminating the need for alveolar bone grafting (ABG) in two-thirds of treated cleft sites. The purpose of this study was to assess if early bone formation as produced by successful GPP influences maxillary canine eruption. Methods/Description: A retrospective chart review was conducted to identify patients born between January 1, 2000, and December 31, 2007, with unilateral complete cleft lip and alveolus, with or without cleft palate. Patients were included if they had successful GPP or ABG, and had panoramic or maxillary CBCT radiographs available at age 5 to 9 (T1) and 9 to 12 (T2) years, with a minimum of 6 months between radiographs. Panoramic images were excluded if a head positioning error produced an occlusal plane greater than 15degree from perpendicular to midline. Panoramic images were used to assess maxillary canine sector, angulation relative to midline and ipsilateral occlusal plane, and cusp tip height from ipsilateral occlusal plane. CBCT images were used to assess the horizontal distance between the canine cusp tip and the maxillary arch form. Clinical charts were reviewed to determine if canines erupted successfully or required intervention. Finally, canine mesial-distal and labio-lingual position after eruption was assessed using occlusal photographs. Outcomes in GPP and ABG groups were compared, and results were stratified by ipsilateral lateral incisor presence or absence.
Result(s): Seventy-nine patients met inclusion; 24 had successful bone fill after GPP, and 55 after ABG. In patients with cleft-side lateral incisors present, no significant differences were found between GPP and ABG groups in canine angulation, height, sector, eruptive outcome, or timing of eruption. When spontaneous canine eruption occurred, there was a statistically nonsignificant trend to more mesial eruptive position in patients who were treated with GPP. In patients with cleft-side lateral incisor agenesis, initial canine angulation did not differ. Patients who were treated with GPP demonstrated 10.8degree +/- 11.1degree spontaneous canine uprighting from T1 to T2, while canine angulation was maintained in the ABG group; this difference was statistically significant (P = .001). The GPP group demonstrated greater canine descent from T1 to T2, resulting in significantly less distance from the occlusal plane (5.8 +/- 4.8 mm) compared to the ABG group (9.4+/-4.2 mm). Horizontal distance to arch did not differ between the groups. In the GPP group, 75% of patients demonstrated successful spontaneous canine eruption, compared to 41% in the ABG group, though this did not reach statistical significance (P = .146).
Conclusion(s): Gingivoperiosteoplasty favorably influenced the angulation, height, and eruptive success of cleft-side canines in patients. These benefits were predominantly noted in patients with congenital absence of lateral incisors
EMBASE:629011173
ISSN: 1545-1569
CID: 4051482

Incidence of secondary midface advancement at the time of skeletal maturity in patients with a History of Early LeFort III Distraction Osteogenesis [Meeting Abstract]

Cho, G; Borab, Z; Gibson, T; Shetye, P; Grayson, B; Flores, R; McCarthy, J
Background/Purpose: LeFort III distraction osteogenesis is commonly recommended for children with syndromic craniosynostosis to reduce exorbitism, improve airway function, and decrease dysmorphism. This purpose of this study is to report on the long-term clinical outcomes of patients with syndromic craniosynostosis patients who have undergone early primary subcranial LeFort III distraction osteogenesis and who have been followed longitudinally through skeletal maturity. Methods/Description: Retrospective review of all patients who underwent LeFort III distraction osteogenesis between the ages of 3 and 11 years and were followed throughout development with longitudinal dental, medical, radiographic, and photographic evaluations conducted through skeletal maturity and beyond. Inclusion criteria entailed having preoperative medical photographs and cephalometric studies at 6 months and 1, 5, and 10 years postoperatively after the primary LeFort III distraction osteogenesis as well as cephalometric documentation 6 months and 1 year after the secondary midface advancement after skeletal maturity.
Result(s): Seventeen patients fulfilled inclusion criteria, with a mean age of 5.7 years at the time of initial LeFort III distraction. The mean advancement of point A was 14.9 mm anteriorly and 2.7 mm inferiorly along the x- and y-axis, respectively. Orbitale moved 10.5 mm anteriorly and 2.2 mm inferiorly along the x- and y-axis, respectively. At 10 years postoperatively, point A moved 3.4 mm anterior along the xaxis and 4.7 mm inferiorly along the y-axis, while orbitale moved 0.4 mm posteriorly and 3 mm inferiorly along the x- and y-axis, respectively. At the time of skeletal maturity, there was a return of occlusal disharmony from normal mandibular growth and a return of proptosis owing to remodeling of orbitale inferiorly, and the lateral orbital rim posteriorly, while the globe continued to grow in the anterior vector. All but 1 study patient underwent or is scheduled to undergo a secondary midface advancement at the LeFort III and LeFort I level after skeletal maturity was attained.
Conclusion(s): The data demonstrate that patients who undergo early LeFort III distraction osteogenesis before the age of mixed dentition will still most likely need a secondary midface advancement after skeletal maturity is reached given that there is a small degree of anterior growth at the level of the maxilla and no anterior growth at orbitale over time
EMBASE:629011081
ISSN: 1545-1569
CID: 4051502

Perioperative complications associated with outpatient vs inpatient primary cleft lip surgery [Meeting Abstract]

Kantar, R; Rifkin, W; Cammarata, M; Plana, N; Diaz-Siso, J R; Flores, R
Background/Purpose: Financial constraints are driving hospitals toward shortening patient stay and favoring outpatient surgery when appropriate. This study compares perioperative complications between the outpatient and inpatient settings in patients undergoing primary cleft lip surgery (PCLS) and identifies risk factors associated with complications and longer lengths of stay. Methods/Description: The American College of Surgeons National Surgical Quality Improvement Program Pediatric database (ACS NSQIP-Pediatric) was reviewed from 2012 to 2015 using Current Procedure Terminology (CPT) codes for PCLS. Patients older than 5 years or undergoing concurrent cleft palate surgery were excluded. The objective of our study was to compare perioperative complications following outpatient vs inpatient PCLS. Statistical analyses were performed using SPSS (version 21.0; IBM Corp, Armonk, NY).
Result(s): We identified 3142 (1721 inpatient vs 1421 outpatient) eligible patients. The majority of patients were males (63.0%) and underwent unilateral PCLS (78.5%). Plastic surgeons were the most frequent providers (85.1%) performing these procedures followed by otolaryngologists (14.0%). The most commonly performed concurrent procedures were cleft lip rhinoplasty (24.2%) and tympanostomy tube insertion (4.7%). Tissue grafting and gingivoperiosteoplasty were each performed in 1.2% of patients. Mean age in days and weight in kilograms at surgery were 200.8+/-223.3 and 7.0+/-3.2, respectively. Mean age (222.6+/-258.7 vs 182.9+/-187.7; P < .001) and weight (7.1 +/- 3.2 vs 6.9 +/- 3.5; P = .03) were significantly higher in the outpatient group. The inpatient group included a significantly higher proportion of patients with cardiac risk factors (12.9% vs 9.4%; P = .002) and oxygen dependence (1.1% vs 0.4%; P = .02). Rates of surgical site infections, wound dehiscence, reoperation, readmission, 30-day mortality, cardiac arrest, transfusion requirements, reintubation and operative time were comparable between groups on univariate analysis. Multivariate regression showed that an underlying structural pulmonary abnormality was significantly associated with a longer hospital length of stay (B = 4.94, P = .001, 95% CI [2.21,7.66]). No other significant associations were identified on multivariate analysis.
Conclusion(s): Surgical site infections, wound dehiscence, reoperation, readmission, 30-day mortality, and other perioperative complications are comparable in patients undergoing outpatient and inpatient PCLS. Patient selection remains the cornerstone for safe practice. Increasing health care fiscal constraints warrant considering outpatient PCLS for appropriate candidates
EMBASE:629011068
ISSN: 1545-1569
CID: 4051522

The influence of occlusal severity on velopharyngeal competence following orthognathic surgery [Meeting Abstract]

Maliha, S; Kantar, R; Gonchar, M; Parikh, V; Flores, R; Leblanc, E
Background/Purpose: Skeletal Class III malocclusion with maxillary hypoplasia results in anterior-posterior discrepancy of the upper and lower incisors position and lip incompetence. This affects the ability to achieve appropriate placement of tongue and management of the intraoral air pressure for sound production, resulting in perceived nasal emission and abnormal articulatory gestures. The aim of this study is to investigate the relationship between occlusal disharmony, velopharyngeal competence, and speech outcomes in patients with skeletal Class III malocclusion undergoing orthognathic surgery. Methods/Description: Seventy-five consecutive patients between 2015 and 2017 who underwent orthognathic surgery secondary to maxillary hypoplasia were evaluated on type of orthognathic procedure (LeFort I only; LeFort I and III; LeFort I and BSSO); amount of anterior and vertical advancement achieved, severity of skeletal Class III malocclusion, and lip incompetence. Patients were divided into 3 groups: cleft lip and palate, syndromic, and those with noncleft/nonsyndromic skeletal deformity. Each group received speech assessments preoperatively and 3 months postoperatively (velopharyngeal competence, resonance and articulatory integrity, and the Pittsburgh Weighted Speech Score [PWSS]).
Result(s): Following exclusionary analysis, 58 patients were included in the study; cleft lip and palate (n = 28), syndromic (n = 15), and noncleft/nonsyndromic skeletal (n =15). Preoperatively, the cleft palate and syndromic groups with increased mean skeletal discrepancy and lip incompetence values presented with higher total mean PWSS scores, and mean nasal emission values than the noncleft/nonsyndromic group (P <= .001). Postoperatively, the cleft group that underwent LFI only presented with insignificantly improved total PWSS (P <= .99) and nasality (P <= .28) scores. The syndromic patients who had the most severe skeletal discrepancy preoperatively and who underwent an LFI and LFIII combined procedure continued to present with significantly higher mean nasal emission values postoperatively than cleft and noncleft/ nonsyndromic patients undergoing LFI only or LFI and BSSO (P < .001). There was no significant difference in the amount of anterior advancement achieved and degree of velopharyngeal competence.
Conclusion(s): Our results show that orthognathic surgery to correct skeletal disharmony does not provide increased compromise to the velopharynx. However, the severity of the skeletal Class III malocclusion and lip position, especially those with a syndromic diagnosis, increases presence of nasal emission pre- and postoperatively. This study suggests that severity of skeletal Class III malocclusion can contribute to the perception of nasality post orthognathic surgery. Severity of skeletal discrepancy should be considered as an additional iatrogenic factor related to perceived velopharyngeal competence in orthognathic surgery
EMBASE:629010959
ISSN: 1545-1569
CID: 4051552

A Review of Randomized Controlled Trials in Cleft and Craniofacial Surgery

Bekisz, Jonathan M; Fryml, Elise; Flores, Roberto L
This study presents a systematic review of randomized controlled trials (RCTs) in cleft and craniofacial surgery. All studies reporting on RCTs in cleft and craniofacial surgery were identified on PubMed using the search terms "cleft," "velopharyngeal insufficiency," "velopharyngeal dysfunction," "nasoalveolar molding," "gingivoperiosteoplasty," "Pierre Robin sequence," "craniofacial," "craniosynostosis," "craniofacial microsomia," "hemifacial microsomia," "hypertelorism," "Le Fort," "monobloc," "distraction osteogenesis," "Treacher Collins," and "Goldenhar." Studies were excluded if they were not randomized, did not focus primarily on topics related to cleft or craniofacial surgery, included repeat publications of data, or were unavailable in English. Studies were evaluated on demographic and bibliometric data, study size, specific area of focus, and findings reported. Four hundred forty-seven unique studies were identified. One hundred eighty-three papers met inclusion criteria (115 cleft lip and palate, 65 craniofacial, and 3 spanning both disciplines). Sixty-six (36%) were dedicated to topics related to surgical techniques. There were no studies comparing current cleft lip or soft palate repair techniques and no studies on cleft rhinoplasty. The most frequently reported surgical topic was cleft palate. There were several studies on orthognathic techniques which compared distraction osteogenesis to traditional advancement. Most craniofacial operations, such as cranial vault remodeling and frontofacial advancement/distraction, were not represented. Several standard operations in cleft and craniofacial surgery are not supported by Level I evidence from randomized controlled trials. Our community should consider methods by which more RCTs can be performed, or redefine the acceptable standards of evidence to guide our clinical decisions.
PMID: 29084117
ISSN: 1536-3732
CID: 2765962

Histo-morphologic characteristics of intra-osseous implants of WE43 Mg alloys with and without heat treatment in an in vivo cranial bone sheep model

Torroni, Andrea; Xiang, Chongchen; Witek, Lukasz; Rodriguez, Eduardo D; Flores, Roberto L; Gupta, Nikhil; Coelho, Paulo G
WE43 Mg alloy, composed of Mg, Yttrium, Rare Earth elements, and Zirconium, has proved to be a suitable candidate for production of resorbable osteosynthesis implants in both clinical and experimental settings. In a previous study we tested biocompatibility and degradation properties of untreated (as-cast) and artificially aged (T-5) WE43 Mg-alloys as subperiosteal implants on a maxillofacial sheep model. Both the alloy compositions showed excellent biocompatibility, however, with respect to degradation rate, the as-cast form showed increased degradability compared with the T-5. In the present study, we tested the same alloy composition (i.e. as-cast and T-5) to assess their biological behavior and degradation pattern when implanted as endosteal implants on a calvarial bone sheep model. Six implants in form of cylindrical discs were tested in 6 sheep, one per composition of each disc was placed in two monocortical cranial defect created with high speed trephine bur in the parietal bone. After euthanasia at 6 weeks histomorphological analysis of the bone/implant specimens was performed. WE43-as cast showed higher degradation rate, increased bone remodeling, gas pockets formation and osteolysis compared with the T5 alloy. WE43-T5 showed greater bone/implant interface stability, and seemed to be more suitable for fabrication of endosteal bone screws.
PMID: 29398208
ISSN: 1878-4119
CID: 2947982

Three dimensionally printed bioactive ceramic scaffold osseoconduction across critical-sized mandibular defects

Lopez, Christopher D; Diaz-Siso, J Rodrigo; Witek, Lukasz; Bekisz, Jonathan M; Cronstein, Bruce N; Torroni, Andrea; Flores, Roberto L; Rodriguez, Eduardo D; Coelho, Paulo G
BACKGROUND:Vascularized bone tissue transfer, commonly used to reconstruct large mandibular defects, is challenged by long operative times, extended hospital stay, donor-site morbidity, and resulting health care. 3D-printed osseoconductive tissue-engineered scaffolds may provide an alternative solution for reconstruction of significant mandibular defects. This pilot study presents a novel 3D-printed bioactive ceramic scaffold with osseoconductive properties to treat segmental mandibular defects in a rabbit model. METHODS:Full-thickness mandibulectomy defects (12 mm) were created at the mandibular body of eight adult rabbits and replaced by 3D-printed ceramic scaffold made of 100% β-tricalcium phosphate, fit to defect based on computed tomography imaging. After 8 weeks, animals were euthanized, the mandibles were retrieved, and bone regeneration was assessed. Bone growth was qualitatively assessed with histology and backscatter scanning electron microscopy, quantified both histologically and with micro computed tomography and advanced 3D image reconstruction software, and compared to unoperated mandible sections (UMSs). RESULTS:Histology quantified scaffold with newly formed bone area occupancy at 54.3 ± 11.7%, compared to UMS baseline bone area occupancy at 55.8 ± 4.4%, and bone area occupancy as a function of scaffold free space at 52.8 ± 13.9%. 3D volume occupancy quantified newly formed bone volume occupancy was 36.3 ± 5.9%, compared to UMS baseline bone volume occupancy at 33.4 ± 3.8%, and bone volume occupancy as a function of scaffold free space at 38.0 ± 15.4%. CONCLUSIONS:3D-printed bioactive ceramic scaffolds can restore critical mandibular segmental defects to levels similar to native bone after 8 weeks in an adult rabbit, critical sized, mandibular defect model.
PMCID:5812371
PMID: 29433862
ISSN: 1095-8673
CID: 2956942