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Combined Primary Cleft Lip and Palate Repair

Is It Safe?

Kantar, Rami S., MD*,†; Rifkin, William J., BA*; Cammarata, Michael J., BS*; Maliha, Samantha G., BA*; Diaz-Siso, J. Rodrigo, MD*; Farber, Scott J., MD*; Flores, Roberto L., MD*

doi: 10.1097/SCS.0000000000005039
Original Articles
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Background: Single-stage primary cleft lip and palate (PCLP) repair is controversial in the United States, and most patients are treated with a staged approach. In this study, early postoperative complications of the single-stage approach as compared to primary cleft lip (PCL) or primary cleft palate (PCP) alone were evaluated. This study represents the largest cohort of patients undergoing combined cleft lip and palate repair.

Methods: The American College of Surgeons National Surgical Quality Improvement Program-Pediatric database was used to identify patients undergoing single-stage PCLP, PCL, or PCP repairs. Preoperative factors and postoperative outcomes were compared between the 3 groups, as well as within the PCLP group between patients with and without complications. Univariate and multivariate analyses were performed.

Results: A total of: 181 patients were included in the single-stage PCLP group, 1007 in the PCP group and 783 in the PCL group. There was no difference in the rates of early complications between the 3 groups. Within the PCLP group, cardiac risk factors (β = 35.19; 95% confidence interval [CI] 7.88–75.21; P = 0.04) and complications (β = 77.31; 95% CI 35.82–118.79; P < 0.001) were significant risk factors for longer operative time.

Conclusion: Analysis of a national database showed that single-stage PCLP repair is not associated with increased risk of early postoperative complications as compared to primary lip or palate repair alone. In-depth long-term analyses of craniofacial morphology, fistulae rate, speech, and dental outcomes are essential for a comprehensive assessment of the effects of combined cleft lip and palate repair.

*Hansjörg Wyss Department of Plastic Surgery, New York University Langone Health, New York, NY

Department of Surgery, The University of Maryland Medical System, Baltimore, MD.

Address correspondence and reprint requests to Roberto L. Flores, MD, Joseph G. McCarthy Associate Professor of Reconstructive Plastic Surgery, Director of Cleft Lip and Palate Program, and Rami S. Kantar, MD, Hansjörg Wyss Department of Plastic Surgery, New York University Langone Health, 307 E 33rd Street, New York, NY 10016; E-mail: Roberto.Flores2@nyumc.org

Received 19 February, 2018

Accepted 14 August, 2018

The authors report no conflicts of interest.

Single-stage cleft lip and palate repair is a debated treatment for patients with concomitant cleft lip and palate. In the developing world, the single-stage approach may be favored due to the challenges of patient transport, follow-up, and health care access. In the developed world, proponents cite positive psychosocial and speech outcomes, high level of parent satisfaction, and no significant change in craniofacial morphology when compared to the staged approach.1–3 Major concerns regarding the single-stage approach include increased risk of perioperative complications as well as maxillary/palatal growth restriction from earlier scarring of the hard palate, caused by sub-periosteal dissection to achieve closure. Based on these concerns, most patients with cleft lip and palate in the United States are treated with a staged approach; repair of the lip first, followed by the palate around 1 year of age.

Multiple groups have described the overall safety and limited postoperative complications of the single-stage approach.2,4,5 However, all previous studies evaluating outcomes of the procedure were limited by a small number of patients,4,6 or absence of details regarding the nature of encountered postoperative complications.7 In this study, we utilize a national validated surgical outcomes database, the American College of Surgeons (ACS) National Surgical Quality Improvement Program-Pediatric (NSQIP-pediatric) database, to evaluate the rates of early complications in patients undergoing single-stage primary cleft lip and palate (PCLP) repair and compare them to those of patients undergoing primary cleft palate (PCP) or primary cleft lip (PCL) repair alone. To our knowledge, this study describes the largest cohort of patients undergoing single-stage PCLP repair.

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METHODS

Database and Patient Population

Data for patients undergoing PCLP repair were extracted from the NSQIP-Pediatric Participant Use Files (PUF) for the years 2012 to 2015. To create numerically balanced comparison groups, data for patients undergoing PCL or PCP repair alone were extracted from the 2015 PUF (Fig. 1). The NSQIP-pediatric database is a multi-institutional outcome-based registry that includes 30-day perioperative de-identified patient data,8 is HIPAA compliant, and is exempt from institutional review board review. This study was conducted in accordance with the principles outlined in the Declaration of Helsinki.

FIGURE 1

FIGURE 1

The database was retrospectively reviewed for the following current procedure terminology (CPT) codes: 40700 (plastic repair of cleft lip/nasal deformity; primary, partial or complete, unilateral), 40701 (plastic repair of cleft lip/nasal deformity; primary bilateral, 1-stage procedure), 42200 (palatoplasty for cleft palate, soft and/or hard palate only), 42205 (palatoplasty for cleft palate, with closure of alveolar ridge; soft tissue only), and 42210 (palatoplasty for cleft palate, with closure of alveolar ridge; with bone graft) (Fig. 1).

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Study Design

Patients older than 3 years or with missing age, weight, height, or undergoing concomitant noncleft-related procedures were excluded to avoid a heterogeneous patient sample. Procedures such as myringotomy or others that are frequently performed concomitantly were not excluded. Patients undergoing PCLP repair were identified by reviewing CPT codes of the primary procedures performed as well as those of concurrently performed procedures. Combinations of primary CPT codes 42200, 42205, or 42210 and concurrent CPT codes 40700 or 40701, or primary CPT codes 40700 or 40701 and concurrent CPT codes 42200, 42205, or 42210 were identified as PCLP procedures (Fig. 1). To identify patients undergoing PCL or PCP repair alone, the 2015 PUF were reviewed for the mentioned CPT codes, excluding patients undergoing any concurrent cleft procedure (Fig. 1).

Patient preoperative demographics, clinical factors, and comorbidities were compared between the PCLP repair group and the PCP repair group, as well as between all 3 groups: PCLP, PCP, and PCL repairs (Table 1). “Preoperative respiratory support” was defined as ventilator, oxygen, or tracheostomy dependence, while “preoperative pulmonary disease” was defined as chronic lung disease or asthma. Subsequently, outcomes were compared between the PCLP and PCP surgery groups, as well as between all 3 groups: PCLP, PCP, and PCL surgery (Table 2). The primary outcome assessed was complication rate, and secondary outcomes included mechanical ventilation, operative time, and hospital stay. A complication was defined a priori as a composite outcome of any of the following 30-day postoperative adverse events: superficial incisional surgical-site infection (SSI), deep incisional SSI, deep space SSI, superficial wound dehiscence, deep wound dehiscence, reoperation, readmission, cardiac arrest, blood transfusion, reintubation, pneumonia, urinary tract infection, sepsis, deep vein thrombosis, oxygen or nutritional support at discharge, or mortality.

TABLE 1

TABLE 1

TABLE 2

TABLE 2

Among patients undergoing PCLP surgery, a separate analysis was performed comparing demographics, clinical factors, and comorbidities (Table 3), as well as secondary outcomes (Table 4) between patients who developed complications and those who did not. Multivariate regression analysis of secondary outcomes was also performed (Table 5), and details of all complications in the 14 patients who developed them are listed in Table 6.

TABLE 3

TABLE 3

TABLE 4

TABLE 4

TABLE 5

TABLE 5

TABLE 6

TABLE 6

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Statistical Analysis

Categorical variables are reported as frequencies and percentages to their corresponding groups, and continuous variables as “mean ± standard deviation (SD).” Univariate analysis was performed using 1-way analysis of variance or Student's t-test for continuous variables, and Chi-squared or Fisher's exact test (n < 10) for categorical variables. Statistical significance was reached with P ≤ 0.05. Multivariate regression models were used for outcomes significant on univariate analysis to control for potential confounders. Variables included in the regression model were age, height, weight, gender, American Society of Anesthesiology classification, race, surgical team specialty, wound classification, all comorbidities, and outcomes. Only significant associations identified on regression analysis are displayed in Table 5.

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RESULTS

Review of the mentioned CPT codes and application of exclusion criteria identified 181 patients in the PCLP group, 1007 patients in the PCP group, and 783 patients in the PCL group eligible for analysis. Patients in the PCP group were significantly older (429.9 ± 175.7 vs 258.9 ± 204.0 days; P < 0.001), and weighed more (9.4 ± 2.1 vs 7.5 ± 2.1 kg; P < 0.001) at time of surgery than those in the PCLP group (Table 1). There were also significant differences in the distribution of race (P < 0.0001), and surgical team specialty (P < 0.001) between the 2 groups (Table 1). When comparing all 3 groups, there was a significant difference in age (P < 0.001), height (P < 0.001), weight (P < 0.001), gender (P < 0.001), race (P = 0.002), surgical team specialty (P < 0.001) distributions, and wound classification distribution (P = 0.01) (Table 1).

Univariate analysis showed no significant differences in the rates of postoperative complications between the PCLP and PCP surgery groups, or between the 3 groups: PCLP, PCP, and PCL. There were 14 (7.7%) complications in the PCLP group, 79 (7.8%) in the PCP group, and 40 (5.1%) in the PCL group (Table 2). Univariate analysis of secondary outcomes revealed that patients who underwent PCLP surgery had a significantly longer mean operative time than patients in the PCP group (159.1 ± 66.8 vs 142.1 ± 67.2 minutes; P = 0.004). Analysis of secondary outcomes between all 3 surgery groups (PCLP, PCP, and PCL) also revealed significant differences in mean operative time (159.1 ± 66.8 vs 142.1 ± 67.2 vs 125.1 ± 59.4 minutes; P < 0.001) and hospital stay (1.3 ± 0.9 vs 1.6 ± 1.0 vs 1.2 ± 2.0 days; P < 0.001) (Table 2).

When comparing patients with and without complications within the PCLP repair group, there were no significant differences in demographics or other preoperative clinical factors and medical comorbidities (Table 3). Patients with complications, however, experienced significantly longer mean operative time (241.2 ± 92.3 vs 152.4 ± 59.9 minutes; P = 0.01) (Table 4).

Multivariate regression showed that within the PCLP surgery group, patients with preoperative cardiac risk factors (β = 35.19; 95% confidence interval [CI] 7.88–75.21; P = 0.04) and postoperative complications (β = 77.31; 95% CI 35.82–118.79; P < 0.001) experienced significantly longer operative times (Table 5). The most common surgical complication after PCLP repair was superficial incisional SSI (n = 3) (Table 6).

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DISCUSSION

In the US centers, the surgical repair of concomitant cleft lip and palate is most commonly performed in a staged fashion. According to the American Cleft Palate-Craniofacial Association, the goal for these patients is to repair the cleft lip within the 1st year of life or as early as is considered safe for the infant, and close the palate by the age of 18 months or preferably earlier when possible.9 Since the initial report of the technique in 1958 by Farina,10 multiple groups have evaluated various outcomes following single-stage cleft lip and palate repair.1–7,11–25 All studies evaluating the safety of the single-stage approach consist of case series and suggest that it can be performed safely, with limited postoperative wound complications.2,4–7,18 Importantly, the need for blood transfusions was reported to be as high as one-third of patients by Honigmann.2 A large case series evaluating single-stage surgery safety in 106 patients from Uganda,18 described 2 patients requiring soft palate release for desaturation, 1 patient with lip wound dehiscence, and 7 patients with fistulae requiring surgical closure. An important limitation to previous studies evaluating safety is the limited number of patients, which prevents generalizability of results. In this study, we evaluated early postoperative outcomes in 181 patients undergoing single-stage PCLP surgery from the NSQIP-pediatric database.

The study analysis showed no significant differences in the rate of early postoperative complications between patients undergoing PCLP, PCP, or PCL repair, which supports the overall safety reported by previous studies regarding the single-stage approach.2,4–7,18 Patients undergoing single-stage repair had a significantly longer mean operative time than patients who had PCL or PCP repair alone, which is also consistent with the literature.7 The rate of 30-day complications as defined in the study following single-stage surgery was 7.7%, which falls within the lower value of the previously reported range of 5%4 to 33%.2,18 Complications in the cohort identified in the database consisted primarily of wound complications, including SSI or dehiscence, and 2 patients required reoperation within 30 days. Interestingly, no patients undergoing PCLP repair in the study required postoperative blood transfusions, as compared to rates as high as one-third of patients in previously published studies.2,18 The cohort evaluated in this study had a mean age of almost 9 months, as compared to 6 months in previous reports.2 Younger patient age as well as performing the procedure in an outreach setting18 may have possibly prompted a lower transfusion threshold to ensure patient hemodynamic stability in these studies, which could account for the higher rate of postoperative transfusions.

Within the PCLP repair group, there were no differences in preoperative demographics, clinical factors, and comorbidities between patients who developed postoperative complications and those who did not. Patients with complications had a significantly longer mean operative time. After adjusting for potential confounders, we found that postoperative complications and preoperative cardiac risk factors were significant independent risk factors for longer operative duration. The association between complications and operative time is not surprising, as prolonged operative time may reflect increased procedural complexity and therefore an increased risk for postoperative adverse outcomes. Short et al showed a significant association between operative time and postoperative complications across 33 procedure types within pediatric surgery, including cleft lip and palate repairs.26 The frequency of preoperative cardiac risk factors in this cohort (10.5%) was comparable to the 10% rate reported in the literature.27 The intraoperative management of patients with orofacial clefts is more challenging in patients with associated congenital abnormalities,28 especially when they are cardiac in nature,27 as congenital heart disease increases the likelihood of a prolonged transitional circulation between fetal and adult circulation.29 This predisposes these patients to intraoperative hypoxemic events,29 underscoring the need for pediatric cardiac anesthesiology expertise when managing patients with cleft lip and/or palate affected by congenital heart disease.30 These factors, combined with the known special considerations in airway management of patients affected by cleft lip and/or palate,28 may explain why the presence of preoperative cardiac risk factors was an independent risk factor for prolonged operative time in patients undergoing PCLP repair in this study.

Major concerns of early single-stage cleft surgery are maxillary and palatal growth restriction from palatal scarring. We are unfortunately unable to evaluate the effects of single-stage cleft repair on craniofacial morphology through this cohort due to the nature of the NSQIP-pediatric database. The majority of studies available in the literature showed no difference in craniofacial morphology between the single-stage and staged approaches,3,11,12,14,17,24 although unsurprisingly, maxillary retrusion, shortening, and posterior rotation were observed when patients undergoing single-stage repair were compared to children with no history of cleft.11,16,17 Nasolabial morphology was found to be satisfactory in patients undergoing single-stage repair,23,25 while the effects on dental arch relationships were mixed.13,15 The psychosocial effect of single-stage repair on patients and families appears to be positive,1,21 which is probably attributable to limiting the number of patient procedures and exposure to anesthesia. Luyten et al1 report a parental satisfaction rate with patient facial features as high as 100%. Importantly, only 54% of patients were found to have completely normal speech following single-stage repair in a study by Hortis-Dzierzbicka et al.19 Luyten et al1 report a 56% rate of parental satisfaction with patient speech outcomes, while other studies describe more encouraging outcomes.5,6,20,21

The mean ages of patients in this study are noteworthy: almost 6 months for the PCL group, 14 months for the PCP group, and 9 months for the single-stage group. These represent slightly older ages than typically performed at major cleft centers, which commonly perform cleft lip repair around 3 months of age, and palate repair by 1 year. We are unable to determine which patients underwent cleft lip repair with a multidisciplinary team, but it is possible that the relatively older age of primary repair encountered in this study may be due to patients undergoing cleft surgery in a community setting where protocol-driven care may be less prevalent. On the contrary, community surgeons providing cleft services might be tempted to perform single-stage repair in patients who are at risk of loss to follow-up.

Significant loss to follow-up in developing countries, reported to be as high as 40%,18 has been described as a major driver for performing early single-stage cleft repair by Hodges18 and Guneren et al,7 even in patients as young as 3 months.18 In a series of 106 patients undergoing simultaneous cleft lip and palate surgery in Uganda, Hodges report a fistula rate of 6.5% and that almost a third of patients (28%) required blood transfusions.18 However, the authors of the same study describe that the majority of fistulae were located in the anterior palate, and the rates of other wound complications were negligible. Similarly, Guneren et al describe negligible wound and overall complication rates in a series of 25 patients undergoing combined cleft lip and palate repair in Africa, Asia, and the Middle East.7 Furthermore, Luyten et al1 evaluated parental satisfaction in a series of 44 patients who underwent simultaneous cleft lip and palate surgery in Uganda, and report a 100% satisfaction rate with patient facial appearance, 98% with hearing, 93% with lip appearance, 86% with nasal appearance, and 56% with speech and appearance of the teeth. Given all of these findings and a mortality rate as high as 75% reported in children who do not undergo palatal repair in developing countries,18 it seems reasonable to suggest that in the outreach setting and developing countries, the benefits of cost-saving and early patient supplementation with adequate nutrition associated with early combined cleft lip and palate repair, could potentially outweigh the risks of the procedure and loss to follow-up.1,7,18

The NSQIP-pediatric database and this study have several limitations. The database does not include detailed hospital definitions of type of palatal defect, surgical technique, wound descriptions, functional outcomes, and outcomes beyond 30 postoperative days. The limited history of previous surgeries prevents us from determining which patients within the palate repair only group had previously undergone cleft lip repair. Furthermore, perinatal history as well as history of genetic diagnoses is not included in the database. Another limitation is the inability to determine the exact temporal relationship of postoperative outcomes, such as time to wound complication. Although we demonstrate that single-stage PCLP repair is not associated with an increased risk of early complications as compared to PCL or palate repair alone, the structure of the NSQIP-pediatric database limits our ability to identify variables such as Veau classification, description of lip deformity, and lip or palate repair technique. Furthermore despite our results suggesting that PCLP repair can be safely combined, we cannot strongly comment on the aesthetic outcomes of cleft lip repair, the functional outcomes of palatoplasty, the incidence of fistula formation or the effects on facial growth. In addition, while the results of the analysis in this study are encouraging, they do not allow us to provide recommendations for best practice given the retrospective nature and limitations of the database, and future long-term prospective studies are needed to better delineate a true causal relationship between combined cleft lip and palate repair and postoperative outcomes. These issues are areas of interest and future study. Despite these limitations, this study represents the largest reported cohort of patients undergoing single-stage PCLP repair and offers valuable insight into 30-day postoperative outcomes and risk factors for complications in patients who develop them.

While the American Cleft Palate-Craniofacial Association guidelines recommend that a staged approach should be adopted in patients presenting with concomitant cleft lip and palate, it is extremely important that cleft teams evaluate patients on a case-by-case basis and tailor treatment accordingly. In developing settings where patients face significant travel difficulties and are often lost to follow-up, the single-stage approach may be preferred. Furthermore, review of the literature through this study showed that there is no evidence to suggest that there are significant differences in craniofacial morphology between patients with concomitant cleft lip and palate undergoing the single-stage or staged approach. Through this study, we sought to evaluate the practice of simultaneous cleft lip and palate repair in the United States using a national validated database and evaluate associated postoperative complications.

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CONCLUSION

While the trend in the United States is to use a staged approach for combined cleft lip and palate defects, analysis of a national validated database did not identify an increased risk of early postoperative complications in patients undergoing single-stage PCLP repair as compared to primary lip or palate repair alone. While outcomes from previous studies are encouraging, rigorous long-term analyses of craniofacial morphology, fistulae rate, speech, and dental outcomes are essential to fully understand the effects of combined cleft lip and palate repair. Surgeon clinical judgment and evaluation of patient clinical condition as well as social support, and follow-up reliability are critical when selecting patients for single-stage PCLP surgery.

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REFERENCES

1. Luyten A, D’Haeseleer E, Budolfsen D, et al. Parental satisfaction in Ugandan children with cleft lip and palate following synchronous lip and palatal repair. J Commun Disord 2013; 46:321–329.
2. Honigmann K. One-stage closure of uni- and bilateral cleft lip and palate. Br J Oral Maxillofac Surg 1996; 34:214–219.
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Keywords:

Combined cleft repair; patient safety; primary cleft lip and palate repair; single-stage cleft surgery; surgical outcomes

© 2019 by Mutaz B. Habal, MD.