Development and Preliminary Evaluation of A Soft Tissue Microtia Simulator.

Surgical simulation has been used extensively for learning microtia reconstruction and has almost exclusively involved framework creation. However, soft tissue reconstruction in microtia is equally challenging and would benefit from a simulation platform. This study aimed to describe the development and preliminary evaluation of a high-fidelity soft tissue microtia simulator. Three-dimensional modeling software, fused deposition 3-dimensional printing, adhesive techniques, silicones, and polyurethane rubbers were utilized to create a right lobular-type microtia simulator that comprises skin, subcutaneous tissue, and cartilage. Two expert microtia surgeons performed a microtia reconstruction on the simulator and evaluated its value and realism using a Likert-type questionnaire. The surgeons utilized a previously developed synthetic framework and successfully performed the critical steps of the soft tissue reconstruction, including marking, incising, dissection, removal of the cartilage remnant, drain insertion, insertion of the framework, closing of the skin, and demonstration of the soft tissue conforming over the framework using suction. A preliminary assessment of the simulator demonstrated that the simulator is anatomically accurate, realistic, and highly valuable as a training tool. A high-fidelity soft tissue microtia simulator was successfully developed and tested. The simulator provides a valuable training platform for learning a critical component of microtia reconstruction.

Evaluation of a high-fidelity cleft alveolar bone graft simulator.

INTRODUCTION: Cleft alveolar bone graft surgery is technically challenging to perform as well as difficult to learn and teach. A high-fidelity cleft alveolar bone graft simulator was previously developed. However, further evaluation of the simulator is necessary to assess its efficacy. METHODS: Two cleft simulation workshops were conducted in which participants were led through a simulated cleft alveolar bone graft. The first simulation workshop involved six plastic surgery trainees. The second workshop involved 43 practicing cleft surgeons. The participants were provided with a Likert-type questionnaire assessing the simulators' features, realism, and value as a training tool. The change in self-reported confidence was assessed by providing each participant with a pre- and post-simulation confidence questionnaire. RESULTS: There was overall agreement in the realism of the simulators' features (average score of 4.67 and 3.80 out of 5 for the trainees and surgeons, respectively). There was overall agreement to strong agreement in the simulators value as a training tool (average score of 5 and 4.43 out of 5 for the trainees and surgeons, respectively). The self-reported confidence increased for all questionnaire items for both the trainees and surgeons. This was significant (p < 0.05) for five out of eight and all questionnaire items for the trainees and surgeons, respectively. The magnitude of the confidence increase was generally greater for less experienced participants. CONCLUSION: The cleft alveolar bone graft simulator was found to be realistic and valuable as a training platform. Use of the simulator improved self-reported confidence in cleft alveolar bone graft surgery.

State of the art: The Unilateral Cleft lip and Nose Deformity and Anatomic Subunit Approximation.

The anatomic subunit approximation approach to unilateral cleft lip repair was developed over 20 years ago. While the underlying principles of the repair are unchanged, its description has been simplified, additional landmarks and creases have been added, and objective analysis of perioperative changes have provided better clarity regarding goals and desired alterations. We review recent insights regarding the deformity; describe the repair in a simplified manner; and link a stepwise approach to foundation-based primary rhinoplasty as a part of the avenue to creating nasolabial balance and harmony.

L'approximation de la sous-unité anatomique pour réparer la fissure palatine unilatérale a été mise au point il y a plus de 20 ans. Les principes fondamentaux de la réparation n'ont pas changé, mais la description est simplifiée et des repères et des plis ont été ajoutés, sans compter qu'une analyse objective de la malformation et des changements chirurgicaux ont permis de mieux comprendre les objectifs ainsi que les modifications souhaitées. Les auteurs analysent la malformation dans le contexte de récentes études objectives, décrivent la réparation selon des concepts contemporains et relient une approche graduelle à la rhinoplastie primaire fondamentale dans le cadre de la trajectoire visant à créer une harmonie et un équilibre nasolabiaux.

Bilateral Cleft lip Simulation.

OBJECTIVE: To evaluate the features, anatomic accuracy, and educational value of a high-fidelity bilateral cleft lip simulator. DESIGN: Evaluation of the simulator by expert cleft surgeons after performing a simulated bilateral cleft lip repair. SETTING: The simulator was evaluated by the surgeons during the Latin American Craniofacial Association meeting. PARTICIPANTS: Eleven experienced cleft surgeons evaluated the simulator. The cleft surgeons were selected based on their availability during the meeting. INTERVENTIONS: The participants performed a simulated bilateral cleft lip repair. They were each provided with a questionnaire assessing the simulator's features, realism and value as a training tool. MAIN OUTCOME MEASURE (S): The main outcome measure are the scores obtained from a Likert-type questionnaire assessing the simulators features, realism and value. RESULTS: Overall, the surgeons agreed with the simulator's realism and anatomic accuracy (average score of 3.7 out of 5). Overall, the surgeons strongly agreed with the value of the simulator as a training tool (average score of 4.6 out of 5). CONCLUSIONS: A high-fidelity bilateral cleft lip simulator was developed that is realistic and valuable as a training tool. The simulator provides a comprehensive training platform to gain hands-on experience in bilateral cleft lip repair before operating on real patients.

Development and Evaluation of a High-Fidelity Rhinoplasty Simulator.

SUMMARY: Rhinoplasty is a challenging procedure with a steep learning curve. Surgical simulators provide a safe platform to gain hands-on experience without compromising patient outcomes. Therefore, rhinoplasty is an ideal procedure to benefit from an effective surgical simulator. A high-fidelity rhinoplasty simulator was developed using three-dimensional computer modeling, three-dimensional printing, and polymer techniques. The simulator was tested by six surgeons with experience in rhinoplasty to assess realism, anatomic accuracy, and value as a training tool. The surgeons performed common rhinoplasty techniques and were provided a Likert-type questionnaire assessing the anatomic features of the simulator. A variety of surgical techniques were performed successfully using the simulator, including open and closed approaches. Bony techniques performed included endonasal osteotomies and rasping. Submucous resection with harvest of septal cartilage, cephalic trim, and tip suturing, as well as grafting techniques including alar rim, columellar strut, spreader, and shield grafts, were performed successfully. Overall, there was agreement on the simulator's anatomic accuracy of bony and soft-tissue features. There was strong agreement on the simulator's overall realism and value as a training tool. The simulator provides a high-fidelity, comprehensive training platform to learn rhinoplasty techniques to augment real operating experience without compromising patient outcomes.

The First Alveolar Bone Graft Simulator.

Alveolar bone graft (ABG) surgery in cleft patients is technically challenging. The procedure requires design, dissection and release of soft tissue flaps to create a seal around the bone graft. In addition, visualization during the procedure is challenging within the confines of the cleft. These features make ABG surgery difficult to learn and teach, and it is, therefore, a suitable procedure for the use of a simulator. A high-fidelity cleft ABG simulator was developed using three-dimensional printing, polymer, and adhesive techniques. Simulated ABG surgery was performed by two expert cleft surgeons for a total of five simulation sessions to test the simulator's features and the ability to perform the critical steps of an ABG. ABG surgery was successfully performed on the simulator. The simulations involved interacting with realistic dissection planes as well as multi-layered synthetic soft (periosteum, mucosa, gingiva, adipose tissue) and hard (teeth, bone) tissue. The simulator allowed performance of cleft marginal incisions, dissection, and elevation of a muco-gingival-periosteal flap, creation of nasal upturned and palatal downturned flaps, nasal and palatal side closure, insertion of simulated bone graft material, and advancement of the muco-gingival-periosteal flap for closure of the anterior wall of the cleft. The ABG simulator allowed performance of the critical steps of ABG surgery. This is the first ABG simulator developed, which incorporates the features necessary to practice the procedure from start to finish.

Surgery for Velopharyngeal Insufficiency Following Cleft Palate Repair: An Audit of Contemporary Practice and Proposed Schema of Techniques and Variations.

OBJECTIVE: Surgical treatment of velopharyngeal insufficiency (VPI) includes a wide array of procedures. The purpose of this study was to develop a classification for VPI procedures and to describe variations in how they are performed.Design/participants/setting/outcomes: We completed an in-depth review of the literature to develop a preliminary schema that encompassed existing VPI procedures. Forty-one cleft surgeons from twelve hospitals across the USA and Canada reviewed the schema and either confirmed that it encompassed all VPI procedures they performed or requested additions. Two surgeons then observed the conduct of the procedures by surgeons at each hospital. Standardized reports were completed with each visit to further explore the literature, refine the schema, and delineate the common and unique aspects of each surgeon's technique. RESULTS: Procedures were divided into three groups: palate-based surgery; pharynx-based surgery; and augmentation. Palate-based operations included straight line mucosal incision with intravelar veloplasty, double-opposing Z-plasty, and palate lengthening with buccal myomucosal flaps. Many surgeons blended maneuvers from these three techniques, so a more descriptive schema was developed classifying the maneuvers employed on the oral mucosa, nasal mucosa, and muscle. Pharynx-based surgery included pharyngeal flap and sphincter pharyngoplasty, with variations in design for each. Augmentation procedures included palate and posterior wall augmentation. CONCLUSIONS: A comprehensive schema for VPI procedures was developed incorporating intentional adaptations in technique. There was substantial variation amongst surgeons in how each procedure was performed. The schema may enable more specific evaluations of surgical outcomes and exploration of the mechanisms through which these procedures improve speech.

The First Hybrid International Educational Comprehensive Cleft Care Workshop.

OBJECTIVE: Describe the first hybrid global simulation-based comprehensive cleft care workshop, evaluate impact on participants, and compare experiences based on in-person versus virtual attendance. DESIGN: Cross-sectional survey-based evaluation. SETTING: International comprehensive cleft care workshop. PARTICIPANTS: Total of 489 participants. INTERVENTIONS: Three-day simulation-based hybrid comprehensive cleft care workshop. MAIN OUTCOME MEASURES: Participant demographic data, perceived barriers and interventions needed for global comprehensive cleft care delivery, participant workshop satisfaction, and perceived short-term impact on practice stratified by in-person versus virtual attendance. RESULTS: The workshop included 489 participants from 5 continents. The response rate was 39.9%. Participants perceived financial factors (30.3%) the most significant barrier and improvement in training (39.8%) as the most important intervention to overcome barriers facing cleft care delivery in low to middle-income countries. All participants reported a high level of satisfaction with the workshop and a strong positive perceived short-term impact on their practice. Importantly, while this was true for both in-person and virtual attendees, in-person attendees reported a significantly higher satisfaction with the workshop (28.63 ± 3.08 vs 27.63 ± 3.93; P = .04) and perceived impact on their clinical practice (22.37 ± 3.42 vs 21.02 ± 3.45 P = .01). CONCLUSION: Hybrid simulation-based educational comprehensive cleft care workshops are overall well received by participants and have a positive perceived impact on their clinical practices. In-person attendance is associated with significantly higher satisfaction and perceived impact on practice. Considering that financial and health constraints may limit live meeting attendance, future efforts will focus on making in-person and virtual attendance more comparable.

Sella turcica dimensions and maxillary growth in patients with unilateral cleft lip and palate.

OBJECTIVES: We aimed to investigate associations between sella turcica dimensions and maxillary growth in children with unilateral cleft lip and palate (UCLP). METHODS: Forty-nine patients with non-syndromic UCLP, prior to secondary alveolar bone-grafting, were included. The outcomes measured were sella turcica and maxillary cephalometric measurements, and scores representing dental arch relationships derived from dental casts. On lateral cephalograms, sella width, height, and area were measured, as well as maxillary length, height, protrusion, and inclination. Dental arch relationships were measured using the modified Huddart/Bodenham (MHB) scoring system, and translated GOSLON yardstick score. Multiple linear regression was used to assess associations between sella turcica measurements and either cephalometric parameters or MHB/GOSLON scores, including age and sex as covariables. RESULTS: No significant associations were found between sella turcica dimensions and dental arch relationships. For cephalometric measurements, sella height and area were associated with basal maxillary length, alveolar maxillary length, and anterior maxillary height. CONCLUSIONS: Sella height and area seem to be predictors for both maxillary length and height as assessed cephalometrically, in a sample of patients with non-syndromic UCLP.

Comparison of Presurgical Anthropometric Measures of Right and Left Complete Unilateral Cleft Lip and/or Palate.

BACKGROUND: Left clefts occur twice as frequently as right ones. The sidedness has been suggested to influence certain outcomes. Some surgeons consider a right cleft more challenging to repair. This is often attributed to their reduced prevalence. The authors question whether this may be caused by morphologic differences. The authors' hypothesis is that there are anthropometric differences between left and right complete cleft lips. METHODS: Patients with complete unilateral cleft lip, with or without cleft palate, operated on at the age of 3 to 6 months, between 2000 and 2018, by a single surgeon, were included. Eight standardized anthropometric measurements of the cleft lip, collected just before cleft lip repair, compare lip and vermillion dimensions and ratios between left and right clefts. RESULTS: One hundred thirty-nine left and 80 right unilateral cleft lips were compared. A significant difference was found between left and right clefts for cleft-side to non-cleft-side ratios comparing the lateral lip element vertical heights and vermillion heights. CONCLUSIONS: Patients with right cleft lips have a greater degree of lateral lip element hypoplasia, demonstrating greater deficiencies of lateral lip element vertical height and vermillion height when compared to patients with left clefts. This has clinical implications for preoperative assessment, choice of surgical technique, and postoperative and long-term outcomes.

An international study to develop the EAR-Q patient-reported outcome measure for children and young adults with ear conditions.

BACKGROUND: There is currently a lack of patient-reported outcome measures for ear reconstruction. We developed the EAR-Q to measure ear appearance and post-operative adverse effects from the patient perspective. METHODS: Field-test data were collected from children and young adults in eight countries between 13 May 2016 and 12 December 2019. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine their psychometric properties. RESULTS: Participants had microtia (n = 607), prominent ears (n = 145) or another ear condition (n = 111), and provided 960 assessments for the Appearance scale (e.g., size, shape, photos), and 137 assessments for the Adverse Effects scale (e.g., itchy, painful, numb). RMT analysis led to the reduction of each scale to 10-items. Data fit the Rasch model for the Appearance (X2(80) = 90.9, p = 0.19) and Adverse Effects (X2(20) = 24.5, p = 0.22) scales. All items in each scale had ordered thresholds and good item fit. There was no evidence of differential item function for the Appearance scale by age, gender, language, or type of ear condition. Reliability was high for the Appearance scale, with person separation index (PSI) and Cronbach alpha values with and without extremes ≥0.92. Reliability for the Adverse Effects scale was adequate (i.e., PSI and Cronbach alpha values ≥0.71). Higher scores (liked appearance more) correlated with higher scores (better) on Psychological, Social and School scales. INTERPRETATION: The EAR-Q can be used in those 8-29 years of age to understand the patient perspective in clinical practice and research, and in addition, can be used to benchmark outcomes for ear reconstruction internationally.

Feasibility of Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching to Reduce Fistula Incidence following Cleft Palate Repair: A Pilot Trial.

BACKGROUND: Improving surgeons' technical performance may reduce their frequency of postoperative complications. The authors conducted a pilot trial to evaluate the feasibility of a surgeon-delivered audit and feedback intervention incorporating peer surgical coaching on technical performance among surgeons performing cleft palate repair, in advance of a future effectiveness trial. METHODS: A nonrandomized, two-arm, unblinded pilot trial enrolled surgeons performing cleft palate repair. Participants completed a baseline audit of fistula incidence. Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique. All others were allocated to simple feedback (receiving audit results). Outcomes assessed were proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention. RESULTS: Seven surgeons enrolled in the trial. All seven completed the baseline audit and disclosed their fistula incidence to other participants. The median baseline fistula incidence was 0.4 percent (range, 0 to 10.5 percent). Two surgeons were unable to receive the feedback intervention. Of the five remaining surgeons, two were allocated to intensive feedback and three to simple feedback. All surgeons completed their assigned feedback intervention. Among surgeons receiving intensive feedback, fistula incidence was 5.9 percent at baseline and 0.0 percent following feedback (adjusted OR, 0.98; 95 percent CI, 0.44 to 2.17). CONCLUSION: Surgeon-delivered audit and feedback incorporating peer coaching on technical performance was feasible for surgeons.

Unilateral Cleft Lip Nasal Deformity: Foundation-Based Approach to Primary Rhinoplasty.

BACKGROUND: Cleft lip results in disruption of the nasal foundation and collapse of tip structures. Most approaches to primary rhinoplasty focus on correction of lower lateral cartilages; however, recurrent deformity is common, and secondary revision is frequently required. The authors describe an alternate approach that focuses on the foundation to "upright the nose," without any nasal tip dissection. This study assessed changes with surgery and with growth. Secondary goals were to compare methods of sidewall reconstruction and septoplasty and to identify predictors of relapse. METHODS: Consecutive patients undergoing repair (n = 102) were assessed. Images were captured preoperatively, postoperatively, and at 5 years of age (when available) using three-dimensional stereophotogrammetry. Standard anthropometric and contemporary shape-based analysis (volume ratio, dorsal deviation, and alar-cheek definition) was performed to assess longitudinal changes. Images of age-matched normal control subjects were used for comparison. RESULTS: Significant changes in anthropometric and morphometric measurements occurred following surgery. Postoperative form was similar to controls immediately after surgery and at 5 years. Nasal corrections were satisfactory, and only two patients have elected to undergo revision. When subjects were grouped according to cleft type, we found the same trends. When comparing different methods of nasal sidewall reconstruction or septoplasty, we found no differences. Alveolar cleft width was a significant predictor of worse preoperative and postoperative form. CONCLUSIONS: Significant nasal correction can be achieved by means of reconstruction of nasal foundation, without nasal tip dissection. Preservation of tissue planes may allow for easier secondary revision, if necessary. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Economy of Hand Motion During Cleft Palate Surgery Using a High-Fidelity Cleft Palate Simulator.

OBJECTIVE: The objectives of this study were to assess economy of hand motion of residents, fellows, and staff surgeons using a high-fidelity cleft palate simulator to (1) stratify performance for the purpose of simulator validation and (2) to estimate the learning curve. DESIGN: Two residents, 2 fellows, and 2 staff surgeons performed cleft palate surgery on a high-fidelity cleft palate simulator while their hand motion was tracked using an electromagnetic hand sensor. The time, number of hand movements, and path length of their hands were determined for 10 steps of the procedure. The magnitude of these metrics was compared among the 3 groups of participants and utilized to estimate the learning curve using curve-fitting analysis. RESULTS: The residents required the most time, number of hand movements, and path length to complete the procedure. Although the number of hand movements was closely matched between the fellows and staff, the overall total path length was shorter for the staff. Inverse curves were fit to the data to represent the learning curve and 25 and 113 simulation sessions are required to reach within 5% and 1% of the expert level, respectively. CONCLUSION: The simulator successfully stratified performance using economy of hand motion. Path length is better matched to previous level of experience compared to time or number of hand movements.

Anatomic approximation approach to correction of transverse facial clefts.

Transverse clefts of the oral cavity have significant impacts on both appearance and function. Many methods of repair have been described, but there is no consensus on optimal approach. In addition, dissatisfaction with scars, distortion of appearance, and recurrent deformity have led to complex surgical designs that are difficult to understand and reproduce. We describe a simple approach to repair that is based upon anatomic approximation of lip components and accurate repair of the muscle. Twenty patients underwent repair by the senior author, who devised the approach, and the corresponding author, who adopted it. Eight (62%) patients had right-sided clefts, three (23%) patients had left-sided clefts, and two (15%) patients had bilateral clefts. One patient had an associated branchial cleft remnant, two patients had multiple branchial cleft remnants and tragus deformities, one patient had craniofacial microsomia with microtia, and one patient had a contralateral Tessier 1 cleft. Mean age of the patients at repair was 23 months. All patients achieved normal oral competence, have favorable scars and commissure appearance, and have had no recurrent deformity. None of the patients have required revision. The described surgical approach is reproducible, easy to understand, and can produce favorable outcomes.

Development of a New Patient-reported Outcome Measure for Ear Conditions: The EAR-Q.

BACKGROUND: Patient-reported outcome measures are widely used to improve health services and patient outcomes. The aim of our study was to describe the development of 2 ear-specific scales designed to measure outcomes important to children and young adults with ear conditions, such as microtia and prominent ears. METHODS: We used an interpretive description qualitative approach. Semi-structured qualitative and cognitive interviews were performed with participants with any type of ear condition recruited from plastic surgery clinics in Canada, Australia, United States, and United Kingdom. Participants were interviewed to elicit new concepts. Interviews were audio-recorded, transcribed, and coded using the constant comparison approach. Experts in ear reconstruction were invited to provide input via an online Research Electronic Data Capture survey. RESULTS: Participants included 25 patients aged 8-21 years with prominent ears (n = 9), microtia (n = 14), or another condition that affected ear appearance (n = 2). Analysis of participant qualitative data, followed by cognitive interviews and expert input, led to the development and refinement of an 18-item ear appearance scale (eg, size, shape, look up close, look in photographs) and a 12-item adverse effects scale (eg, itchy, painful, numb). CONCLUSIONS: The EAR-Q in currently being field-tested internationally. Once finalized, we anticipate the EAR-Q will be used in clinical practice and research to understand the patient's perspective of outcomes following ear surgery.

A High Fidelity Cleft Lip Simulator.

BACKGROUND: Cleft lip surgery is technically difficult requiring precise planning and understanding of 3-dimensional structures to obtain an optimal outcome. A physical cleft lip simulator was developed that allows trainees to gain experience in cleft lip repair and primary rhinoplasty before operating on real patients. METHODS: A cleft lip simulator that comprises multilayered soft tissues, bone, and realistic dissection planes was developed using 3D printing, adhesive and polymer techniques. Four experienced cleft surgeons performed a total of 7 simulated repairs on the simulator. Feedback on the realism and value of the simulator was obtained from the surgeons. RESULTS: Six of the repairs were a Fisher anatomic subunit approximation technique, and 1 was a rotation advancement repair. All repairs were completed with successful performance of markings, incisions, dissections, and multilayered closure. All surgeons agreed that the simulator is realistic and that the simulator is a valuable tool for training in cleft lip surgery. CONCLUSIONS: A cleft lip simulator that allows performance of a cleft lip repair and primary rhinoplasty from start to finish was developed and pilot tested. The simulator provides a training platform to gain experience in cleft lip repair before operating on real patients.