Abstract
One hundred and one patients with complete or incomplete cleft lip underwent the anatomical subunit approximation technique for repair. The patients were followed up prospectively for 1 year. The objective of this study was to determine the outcomes for the nasolabial area through anthropometric measurements and assessment of the Asher-McDade Aesthetic Index and Steffensen’s criteria at 1 year after surgery. Six assessors (three cleft surgeons and three non-surgeon medical professionals) examined cropped images; reliability was assessed using Cronbach’s alpha. The difference in lip length between the healthy and operated sides was 0.61 mm and the difference in nostril diameter was 0.37 mm (differences not significant). The average scar width was 2.78 ± 1.35 mm. Hypertrophic scars were observed in 9.9% of cases. The average Asher-McDade Aesthetic Index rating varied between 1.35 and 1.98 for all parameters. Cronbach’s alpha coefficient was 0.83, 0.89, 0.98, and 0.89 for nasal form, nasal symmetry, vermilion border, and nasolabial profile, respectively. Steffensen’s criteria rated appearance as ‘good’ in 69.3% to 91.1% of cases. The anatomical subunit approximation technique can be performed in Sub-Saharan Africans for all types of unilateral cleft lip. It significantly improves the length of the medial and lateral lips, leaving an acceptable scar. A study with a larger sample size and longer follow-up is warranted.
Cleft lip and palate (CLP) represents the most common birth defect affecting the head and neck region; the incidence rate is 1 in 700 live births . Orofacial cleft surgery aims to repair and restore the morphological and functional structures of the lip, nose, and palate. The cosmetic appearance is of greatest relevance in lip repair. Repair of the palate is not restricted solely to closure of the cleft, but entails improved function of the secondary palate. Several plastic surgery schedules have been proposed, and most authors recommend lip repair in infants between 3 and 6 months of age in order to restore aesthetic facial symmetry and functional structures . Facial asymmetry greatly impacts the psychological health of patients .
Many surgeons apply the major principles of aesthetic surgery as stated by Gillies , placing emphasis on analysis of the specific deformity, the repair plan, use of wide dissection, and optimal tissue reconstruction. The quality of the final lip scar is affected by the operative technique, marks placed, and orientation of the incision. The incision may be straight or comprise several flaps . The best approach involves orienting the scars along existing anatomical entities .
Millard’s techniques are known to result in a shortened lip when used to close wide clefts . The Tennison–Randall technique produces a scar that passes through anatomical subunit structures . Fisher has described a technique consisting of 25 landmarks positioned such that the incision passes along the edges of anatomical subunits of the nasolabial area . This technique is considered to be a hybrid technique , and is also termed the anatomical subunit approximation technique.
Hypertrophic scars often produce additional deformation and contractures . Wound healing disorders are commonly observed in Sub-Saharan African patients, who are predisposed to hypertrophic and keloid scars following head and neck surgeries . However, no data supporting this premise after cleft lip repair when using similar procedures have been reported.
Several rating scales for the assessment of CLP repair have been described. Of these, the most commonly used is the Asher-McDade Aesthetic Index .
CLP treatments have been conducted in Lubumbashi via numerous mass campaigns, with various surgical techniques performed according to the experience of each surgeon. However, no longitudinal study on the aesthetic and functional outcomes of patients who have undergone operations by the same surgical team, using the same technique, and involving a Central African population, have been reported to date.
The objective of this study was to determine the outcomes for the nasolabial area at 1 year after the repair of non-syndromic unilateral cleft lip (CL), unilateral cleft lip and alveolus (CLA), or unilateral CLP by means of the anatomical subunit approximation technique in 101 infants in Lubumbashi, DR Congo. The outcomes were determined by performing anthropometric measurements and assessing the Asher-McDade Aesthetic Index and Steffensen’s criteria.
Materials and methods
Study location and period
A prospective study was performed in the city of Lubumbashi, DR Congo, from July 2012 to July 2016. Three teaching hospitals were involved, namely the University Clinic of Lubumbashi, Jason Sendwe Hospital (a provincial reference hospital), and Polyclinic Medicare. The study was conducted by a team of surgeons from the University of Lubumbashi and two general practitioners. The outcome parameter was scar quality, which was rated as either good or a wound healing disorder. A healing disorder was considered pathological, whereas normal scarring was considered the normal outcome.
Patients
The study focused on infants with non-syndromic unilateral CL, unilateral CLA, or unilateral CLP, born in a maternity facility in Lubumbashi health district, who had undergone follow-up by the surgical team since birth or February 2012. All patients included in this study underwent cheilorrhaphy by means of the anatomical subunit approximation technique , under general anaesthesia with orotracheal intubation ( Fig. 1 ). Surgery was performed at between 3 and 8 months of age. Following hospital discharge, all patients underwent regular follow-up every 3 months in order to verify the quality of their scars. They were followed up for 12 months postoperatively. All procedures were performed by the same surgeon and under the same conditions. The protocol and informed consent form were approved by the Medical Ethics Committee of the University of Lubumbashi.
Study parameters
The following demographic and clinical variables were evaluated: sex, age at surgery, age at last clinical measurement, and body mass index (BMI, kg/m 2 ). BMI was classified into two different groups: below or equal to the 50th percentile (≤50th) and above the 50th percentile (>50th).
The cleft type was classified as unilateral cleft lip with or without alveolus (CL ± A) or unilateral cleft lip and palate (CLP). The affected side (left or right) was recorded.
The scar was classified as a flat scar, contracted scar, hypertrophic scar, or depressed scar. Scar colour was considered normal, hypopigmented, or hyperpigmented, whilst scar flexibility was categorized as firm or soft.
The direction of Cupid’s bow was classified as horizontal or oblique. Vermilion was observed to be continuous or discontinuous. The shape of the upper lip was categorized as normal, thick, thin, or exhibiting a notch. Columella could be either not deflected or skewed. The alar dome was indicated to be well-wrapped or flattened. Depending upon the height of the alar base implantation, it was categorized as low or normal.
Three anthropometric parameters for the CL repair were analyzed using a caliper during follow-up, namely the length of the philtrum (comparing the operated side and normal side), scar width, and diameter of the nostril (comparing the operated side and normal side). The triangle width, i.e. the distance between points 18 and 20 in Fig. 1 a, was also recorded. As the study subjects were infants, the measurements were taken during deep sleep in order to obtain facial symmetry in the absence of facial muscle movements. This approach was time-consuming due to the necessity to wait for the infant to fall asleep.
A diagnosis of normal wound healing or scar disorder was recorded after evaluation of the aforementioned parameters. The term ‘scar disorder’ or ‘poor scar quality’ was used to refer to hypertrophic scars, contracted scars, scar widths exceeding 2 mm, discontinuous vermilion, and scars with an oblique orientation of Cupid’s bow. Hypertrophic scars were defined as scars that protruded compared to the normal skin of the upper lip. Contracted scars were defined as scars shorter than the incisions from which they resulted.
Assessment parameters
Assessment of the cosmetic results was conducted based on the Asher-McDade Aesthetic Index and Steffensen’s criteria ( Table 1 ) . Six assessors, who were not involved in conducting the study, evaluated the results: three were cleft surgeons (group 1) and three were non-surgeon medical professionals (group 2). The surgeons and general practitioners who performed the study did not take part as assessors. The assessment was performed using cropped images obtained 1 year after surgery.
| Structures | Appearance | ||
|---|---|---|---|
| Good | Average | Poor | |
| Alar base | At the same level as the normal side | Difference <1 mm compared to the normal side | Difference >1 mm compared to the normal side |
| Alar dome | Equal curvature to the normal side | Any depression compared to the normal side | |
| Cupid’s bow | Perfect | Distortion on the cleft side of <2 mm | Distortion on the cleft side of >2 mm |
| Lip length | Equal length on both sides | Shorter than cleft side by >1 mm and <2 mm | Shorter than cleft side by >2 mm |
| Nostril symmetry | Equal height and width to the normal side | Height or width >1 mm and <2 mm longer than the normal side | Height or width >2 mm longer than the normal side |
| Scar appearance | No hypertrophy | Hypertrophy with no disturbance of cupid’s bow or columella | Hypertrophy with disturbance of cupid’s bow or columella |
| Vermilion border | Perfect | Disparity of <1 mm | Disparity of >1 mm |
| White roll match | Perfect | Disparity of <1 mm | Disparity of >1 mm |
An objective evaluation was performed through physical examination and anthropometric measurements at 1 year after the repair. The consistency of the scar (firm or soft), continuity of the vermilion, orientation of Cupid’s bow, and quality of the upper lip (thin, thick, exhibiting a notch, or normal) were examined.
Statistical evaluation
The reliability of the assessor evaluation by Asher-McDade Aesthetic Index was assessed by means of Cronbach’s alpha coefficient and the inter-class and intra-class correlation coefficients. Reliability was considered significant with a Cronbach’s alpha value exceeding 0.70. The data were recorded in Microsoft Excel version 10, 2002 (Microsoft, Redmond, WA, USA) and processed using IBM SPSS Statistics for Windows version 24.0 software (IBM Corp., Armonk, NY, USA). For the analysis of variance (ANOVA) test, the difference was considered statistically significant at a P -value of <0.05.
Results
A total 101 subjects were enrolled in this research. The patients underwent surgery at between 3 and 8 months of age (mean age 6 months). There were more males than females, with a sex ratio of 1.8:1. Unilateral CL ± A was the most commonly observed presentation (89.1%); CLP accounted for 10.9% of cases. The clefts seen in this study displayed a tendency to be more localized on the left side (72.3%). Complete unilateral cleft lip with or without cleft palate (CL/P) was observed in 91 patients (90.1%) and incomplete CL in 10 patients (9.9%). No statistically significant difference was found between complete CL/P and incomplete CL and the quality of the scar at 1 year post-surgery.
Healing disorders were observed in 18.8%, with hypertrophic scars seen in 9.9% ( Fig. 2 ). Most scars displayed a normal colouration; however, nine patients (8.9%) had hypopigmented scars and one patient (1.0%) had a hyperpigmented scar. The scar was soft in 61.4% of cases, whilst 38.6% of scars were firm. The vermilion was continuous in 85.1% of patients. No case of muscular dehiscence occurred. A notch on the lip was observed in 6.9% of the patients who had undergone surgery. Columella was not deflected in 83.2% of patients and was skewed in 16.8%. The alar dome was well wrapped in 81.2% and slightly flattened in 18.8% of cases. The alar base was positioned low in 8.9% of cases and normally in 91.1%. The mean scar width was 2.78 ± 1.35 mm. Overall, 45.5% of scars were less than 2 mm in width and 14.9% exceeded 4 mm. The mean triangle width was 1.5 mm.
The average philtrum length was 12.87 ± 2.25 mm on the healthy side and 12.26 ± 2.27 mm on the operated side. The difference in length was 0.61 mm, whilst Cronbach’s alpha was 0.93 ( Table 2 ). The transverse nostril diameter was 9.87 ± 2.29 mm on the healthy side and 10.24 ± 2.59 mm on the operated side. The difference was 0.37 mm, whilst Cronbach’s alpha was 0.88 ( Table 2 ).
| Philtrum length | Transverse diameter of the nostril | |
|---|---|---|
| Sample size | 101 | 101 |
| Cronbach’s alpha | 0.93 | 0.88 |
| Inter-class correlation coefficient | 0.87 | 0.79 |
| Intra-class correlation coefficient | 0.93 | 0.88 |
| 95% CI | 0.90–0.95 | 0.82–0.92 |
As shown in Table 3 , there was no statistically significant difference between the sexes with regard to scar quality at 1 year postoperative. The mean BMI of patients with normal scars was 18.94 kg/m 2 and of those with healing disorders was 16.04 kg/m 2 . Most patients with a BMI ≤50th percentile had a scar disorder, whereas most patients with a BMI above the 50th percentile had a normal scar; the difference proved to be statistically significant (odds ratio (OR) 28.31, 95% confidence interval (CI) 7.21–111.19, P < 0.0001). The average scar width in those with normal scars was 2.33 ± 1.13 mm and in those affected by healing disorders was 3.51 ± 1.67 mm. Scar width (>2 mm vs. ≤2 mm) was significantly associated with healing disorders (OR 23, 95% CI 2.93–180.53, P < 0.0001.
| Healing disorder, n | Normal, n | OR | 95% CI | χ 2 | P -value | |
|---|---|---|---|---|---|---|
| Width of the scar | ||||||
| >2 mm | 18 | 36 | 23 | 2.93–180.53 | 16.02 | <0.0001 |
| ≤2 mm | 1 | 46 | 1 | |||
| BMI in kg/m 2 | ||||||
| ≤50th percentile | 16 | 13 | 28.31 | 7.21–111.19 | 35.21 | < 0.0001 |
| >50th percentile | 3 | 69 | 1 | |||
| Sex | ||||||
| Male | 13 | 52 | 1.25 | 0.43–3.63 | 0.02 | 0.4500 |
| Female | 6 | 30 | 1 | |||
| Diagnosis | ||||||
| CL ± A | 18 | 72 | 2.5 | 0.30–20.81 | 0.22 | 0.3438 |
| CLP | 1 | 10 | 1 | |||
| Side | ||||||
| Right | 6 | 22 | 1.26 | 0.43–3.72 | 0.02 | 0.4400 |
| Left | 13 | 60 | 1 | |||
| Scar consistency | ||||||
| Firm | 19 | 20 | – | – | 34.08 | <0.0001 |
| Soft | 0 | 62 | 1 | |||
| Cupid’s bow | ||||||
| Oblique | 6 | 3 | 12.15 | 2.69–54.74 | 11.57 | 0.0012 |
| Horizontal | 13 | 79 | 1 | |||
| Vermilion | ||||||
| Discontinuous | 9 | 6 | 11.4 | 3.35–38.83 | 16.53 | 0.0001 |
| Continuous | 10 | 76 | 1 | |||
| Upper lip | ||||||
| Thick | 4 | 5 | 10.71 | 2.48–46.22 | 10.1 | 0.0029 |
| Notch | 6 | 1 | 64.29 | 6.75–612.56 | 24.92 | <0.0001 |
| Thin | 2 | 1 | 21.43 | 1.72–266.96 | 5.1 | 0.0286 |
| Normal | 7 | 75 | 1 |
The association between scar consistency and scar quality was statistically significant (χ 2 = 34.08, P < 0.0001). Almost all normal scars were flexible, while all poor quality scars were firm. The association between the direction of Cupid’s bow and scar quality was statistically significant (OR 12.15, 95% CI 2.69–54.74, P = 0.0012). The association between vermilion continuity and scar quality also proved statistically significant (OR 11.4, 95% CI 3.35–38.83, P = 0.0001). With regard to the upper lip, there were statistically significant associations between the presence of a notch (OR 64.29, 95% CI 6.75–612.56, P < 0.0001), thick lip (OR 10.71, 95% CI 2.48–46.22, P = 0.0029), and thin lip (OR 21.43, 95% CI 1.72–266.96, P = 0.0286) and the quality of the scar ( Table 3 ).
Table 4 shows the results of the assessor evaluations according to the Asher-McDade Aesthetic Index. Overall, the shape of the nose was considered ‘very good’ in 27.2% of cases and ‘good’ in 54.0%. Nasal symmetry was rated as ‘good’ in 52.0%, ‘very good’ in 40.1%, and ‘average’ in 7.4% of cases. Vermilion was assessed as ‘very good’ in 66.3% of cases and ‘good’ in 31.7%. The nasolabial region in profile view was evaluated as ‘good’ in 75.7% of cases and ‘very good’ in 17.3%.
| Asher-McDade Aesthetic Index a | Group 1 b | Group 2 b | Combined group results |
|---|---|---|---|
| n (%) | n (%) | n (%) | |
| Nasal form | |||
| 1 | 29 (28.7) | 26 (25.7) | 55 (27.2) |
| 2 | 54 (53.5) | 55 (54.5) | 109 (54.0) |
| 3 | 15 (14.8) | 16 (15.8) | 31 (15.3) |
| 4 | 3 (3.0) | 4 (4.0) | 7 (3.5) |
| 5 | 0 (0) | 0 (0) | 0 (0) |
| Nasal symmetry | |||
| 1 | 44 (43.6) | 37 (36.6) | 81 (40.1) |
| 2 | 49 (48.5) | 56 (55.5) | 105 (52.0) |
| 3 | 7 (6.9) | 8 (7.9) | 15 (7.4) |
| 4 | 1 (1.0) | 0 (0) | 1 (0.5) |
| 5 | 0 (0) | 0 (0) | 0 (0) |
| Vermilion border | |||
| 1 | 68 (67.3) | 66 (65.3) | 134 (66.3) |
| 2 | 31 (30.7) | 33 (32.7) | 64 (31.7) |
| 3 | 2 (2.0) | 2 (2.0) | 4 (2.0) |
| 4 | 0 (0) | 0 (0) | 0 (0) |
| 5 | 0 (0) | 0 (0) | 0 (0) |
| Nasolabial profile | |||
| 1 | 17 (16.8) | 18 (17.8) | 35 (17.3) |
| 2 | 76 (75.2) | 77 (76.2) | 153 (75.7) |
| 3 | 8 (7.9) | 6 (5.9) | 14 (6.9) |
| 4 | 0 (0) | 0 (0) | 0 (0) |
| 5 | 0 (0) | 0 (0) | 0 (0) |
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