Predictors of Delayed Cleft Lip and Palate Surgery: A Case–Control Study in Addis Ababa, Ethiopia

Abstract

Background:

Orofacial clefts are common anomalies, and timely treatment is essential for optimal outcomes. In low- and middle-income countries, surgical delays are frequent, yet contributing factors remain understudied. This study aims to identify and quantify these factors at a tertiary medical center in Ethiopia.

Methods:

An institution-based unmatched case–control study was conducted among 98 patients between January 2023 and December 2024. Cases included patients undergoing surgery after the recommended age (cleft lip >6 mo; cleft palate >12 mo), whereas controls received timely surgery. Data were collected from medical records and telephone interviews. Bivariate analysis and multivariate logistic regression were performed to determine predictors.

Results:

Isolated cleft palate (adjusted odds ratio = 21.72; 95% confidence interval [CI], 4.17–113.12; P < 0.001) and greater distance to a cleft center (per kilometer increase: odds ratio = 1.012; 95% CI, 1.003–1.021; P = 0.007) were significantly associated with delayed treatment. Lack of formal education of caregivers showed a strong borderline association (adjusted odds ratio = 8.61; 95% CI, 0.68–108.89; P = 0.096). Post-hoc power exceeded 99.9%. The final model demonstrated good performance, with an area under the receiver operating characteristic curve of 0.875 and acceptable fit (Hosmer–Lemeshow χ² = 11.037; degrees of freedom = 8; P = 0.200).

Conclusions:

Cleft type and geographic barriers were the primary determinants of delayed surgery. Patients with isolated cleft palate and those residing farther from specialized centers had higher odds of delayed treatment. Interventions should focus on improving early detection, referral pathways, and access to cleft care.

Takeaways.

Question: What factors contribute to delayed treatment of cleft lip and/or palate in Ethiopia?

Findings: Isolated cleft palate (adjusted odds ratio = 21.72) and greater distance from a specialized treatment center (per kilometer increase: odds ratio = 1.012) were significantly associated with delayed treatment. Parental illiteracy showed a strong but borderline significant association.

Meaning: Patients with isolated cleft palate and those living farther from specialized care centers have the highest odds of receiving surgery after the recommended period. Children of parents with no formal education may also be at increased risk.

INTRODUCTION

Cleft lip and/or palate (CLP) is the most common craniofacial anomaly.¹ In Addis Ababa, Ethiopia, its incidence is 1.49 per 1000 births.² Timely surgical management is essential, with guidelines recommending cleft lip repair by 6 months and cleft palate repair by 12 months of age.^2–6 Adherence to these timelines reduces mortality and optimizes functional outcomes, including speech, feeding, hearing, and psychosocial well-being.⁵

Despite these recommendations, delays in cleft surgery remain common in low- and middle-income countries.^5,7,8 In Ethiopia, where cleft care service is highly centralized to a few major public hospitals, most patients undergo their first surgery after the age of 5 years,² resulting in adverse effects on speech development, nutrition, and social integration.

Globally, research shows multiple barriers contributing to delayed treatment; these include low socioeconomic status, limited awareness, and geographic inaccessibility to specialized care. However, the relative contribution of these factors within the Ethiopian context remains insufficiently studied and quantified.

Understanding context-specific determinants is essential, as barriers vary across settings. Therefore, this study aims to identify factors associated with delayed cleft treatment at Yekatit 12 Hospital Medical College, providing evidence for targeted interventions and future research. The study site is a public facility that serves as a major cleft center in Addis Ababa, and one of the few facilities in the country capable of providing comprehensive cleft care. In addition to this hospital, a limited number of other public hospitals and private facilities also provide cleft surgery in coordination with charitable organizations that ensure the cleft surgery is provided free of charge for every individual with an orofacial cleft.

LITERATURE REVIEW

The cause of delayed cleft treatment is multifactorial, involving interaction of demographic, clinical, socioeconomic, geographic, and health system–related factors.^3,9

Demographic factors, such as sex and parental education, have been associated with treatment timing. Some studies reported higher odds of delayed surgery among women; for example, Stoneburner et al¹⁰ found that 48.6% of delayed cleft lip repairs occurred in women compared with 33.6% of timely cases (odds ratio [OR] = 1.87). Similarly, men were more likely to receive earlier surgery in Vietnam,⁸ although other studies found no significant sex-based differences.^9,11

Racial disparities have also been reported, with non-Hispanic Black and Hispanic children experiencing more delays in cleft palate repair in the United States.^4,11 Higher parental education is consistently associated with earlier intervention,^8,12 although occupation has shown inconsistent associations.⁸

Clinical characteristics also influence treatment timing. More complex cases, including combined cleft lip and palate, bilateral clefts, and syndromic diagnoses, are often associated with delayed care.¹⁰ However, a study from Nigeria reported that less severe unilateral clefts were treated later than bilateral cases (adjusted hazard ratio = 22.4), suggesting that perceived severity may influence care-seeking behavior.⁹

Socioeconomic constraints are also a major barrier. Poverty, low income, and illiteracy limit access to care,^12,13 with 53% of participants in a study citing financial barriers as the main cause of delay.¹⁴ A multinational study, including Ethiopia, showed that for every $1000 decrease in gross domestic product per capita, the odds of delayed surgery increased by 14% (OR = 0.88; P < 0.001).¹⁵

Geographic factors further contribute to delays. Long travel distances, poor infrastructure, and high transportation costs are consistently associated with delayed treatment.^1,4,8 A multicontinental study found that 60.7% of cleft care providers identified travel cost as the main barrier.¹⁴ In sub-Saharan Africa, only 29% of the population lives within a distance requiring 2 hours to reach a public hospital,³ and in Ethiopia, where 79% of the population is rural,² geographic barriers are likely significant. However, some studies report conflicting findings, with shorter travel distances observed as the cause of delayed treatment among patients in certain settings¹⁰ and no consistent association in others.⁸

Health system limitations and lack of awareness also play important roles. Limited availability of surgical services and healthcare providers contributes to delays,¹² whereas lack of awareness about cleft conditions and treatment options remains a key barrier.¹⁴ Information sources also influence care-seeking behavior, with earlier presentation associated with access to reliable information.⁸ Insurance status shows inconsistent associations with treatment timing.^4,10,11

Referral pathways are another contributing factor. Patients with delayed treatment are more likely to be referred through nonmedical sources, whereas referral by healthcare professionals is associated with earlier intervention.^1,11

In summary, delayed cleft treatment results from complex interactions among demographic, clinical, socioeconomic, geographic, and health system factors. These determinants vary across settings, underscoring the need for context-specific evidence to guide interventions.

METHODOLOGY

Study Design and Setting

An institution-based unmatched case–control study was conducted among patients who underwent their first cleft surgery between January 2023 and December 2024 at the Plastic and Reconstructive Surgery Department of Yekatit 12 Hospital Medical College in Addis Ababa, Ethiopia.

Source and Study Population

The source population comprised all patients with CLP who received their first cleft surgery during the study period. Cases were patients undergoing primary surgery after the recommended age (cleft lip >6 mo; cleft palate >12 mo; combined CLP if either component was delayed), whereas controls underwent surgery within the recommended timeframe. Patients undergoing revision or secondary procedures and those who had prior surgery elsewhere were excluded.

Sampling

A total sample size of 98 participants (49 cases and 49 controls) was calculated using the Fleiss formula with continuity correction and additional 10% contingency for nonresponse, assuming 80% power, 95% confidence level (CI), a 1:1 ratio, and exposure proportions of 79% in cases and 50% in controls.

From an initial population of 311 patients, cases and controls were identified based on age at first surgery (Fig. 1). A simple random sampling technique using a table of random numbers was applied to select 49 participants in each group. Nonresponders and missing data were excluded from each group (cases, N = 9; controls, N = 14).

Fig. 1.

Flow chart of study subject selection.

Data Collection and Quality Assurance

Data were collected using a structured questionnaire administered on Google Forms. The tool was pretested on 5% of the sample patients, who were excluded from the final analysis. Information was obtained from electronic medical records and telephone interviews. Collected variables included demographic, clinical, economic, geographic, healthcare system–related factors, and caregiver awareness.

Predictor Variables

Demographic factors included gender, place of residence, and highest parental education level. Clinical factors comprised cleft type, severity, presence of syndromic conditions, and comorbidities. Economic status with gross household income was also included. Geographic factors included distance to the nearest hospital and cleft center. Healthcare system–related variables included place of delivery, health insurance coverage, and referral method. Caregiver awareness covered knowledge of surgical treatment availability, cleft centers, appropriate timing of treatment, and availability of any charity support.

Operational Definitions

• Awareness of surgical treatment was defined as caregiver knowledge, before the child’s birth, that cleft conditions are surgically treatable.

• Awareness of a cleft center referred to prior knowledge of a specialized cleft care facility before the first visit.

• Knowledge of appropriate treatment timing indicated awareness of the recommended age for cleft lip and palate surgery.

• Awareness of charity support referred to knowledge of organizations providing free cleft surgery.

Statistical Analysis

Data were cleaned, coded, and analyzed using IBM SPSS (version 27) software. Descriptive statistics summarized participant characteristics. Bivariate analyses (χ², Fisher exact, and Mann-Whitney U tests) assessed associations between independent variables and delayed surgery. Variables with a P value of less than 0.05 were considered for multivariable analysis.

Variables with zero-cell counts were excluded, and the final model was limited to 5 clinically relevant variables to avoid overfitting. These included the type of cleft, distance to cleft facility, parental education level, place of residence, and awareness of charity organizations. Multicollinearity was assessed using linear regression diagnostics, with all variables meeting acceptable limits (variance inflation factor < 10, tolerance > 0.1). Model fit was evaluated using the Hosmer–Lemeshow test (χ² = 11.037; degrees of freedom = 8; P = 0.200). Statistical significance was set at a P value of less than 0.05. The model demonstrated strong discrimination, with an area under the receiver operating characteristic curve of 0.875. Post-hoc statistical power was more than 99.9% based on the observed effect size of the primary predictor.

RESULTS

A total of 311 patients underwent first cleft surgery during the study period. Of these, 120 (38.6%) received surgery within the recommended timeframe, whereas 191 (61.4%) experienced delayed treatment. This represents an improvement compared with a previous Ethiopian report (20.76%)² and is higher than the proportion of timely treatment (28.8%) reported in a multicountry African study.⁵

Bivariate analysis identified significant associations between delayed treatment and 6 categorical variables: isolated cleft palate, rural residence, lack of parental education, home delivery, awareness of surgical availability, and awareness of charity organizations. (See table, Supplemental Digital Content 1, which displays the summary of bivariate analyses for categorical variables [χ² and Fisher exact tests], https://links.lww.com/PRSGO/F333.) Three continuous variables were also significant: lower household income, greater distance to a public hospital, and greater distance to cleft center (Table 1).

Table 1.

Summary of Nonparametric Test for Continuous Variables (Mann-Whitney U Test)

Variable	Group	Median (IQR)	Range (Minimum–Maximum)	P
Estimated household monthly income, Birr	Cases	4000 (3000)	2000–22,000	<0.001*
	Controls	8000 (4000)	2000–35,000
Estimated distance to nearest public hospital, km	Cases	10 (16)	3–50	<0.001*
	Controls	6 (3)	1–13
Estimated distance to nearest cleft care center, km	Cases	130 (289)	3–600	<0.001*
	Controls	14 (13)	6–350

^*Statistically significant at P < 0.05.

IQR, interquartile range.

In multivariable logistic regression (Table 2), 3 factors remained independently associated with delayed treatment. Isolated cleft palate was the strongest predictor, with patients having 21 times higher odds of delay compared with cleft lip or combined clefts (AOR = 21.72; 95% CI, 4.17–113.12; P < 0.001). This pattern is illustrated in Figure 2 and is consistent with findings by Eshete et al,⁵ where median age at cleft palate surgery was 25 months.

Table 2.

Multivariate Logistic Regression Model for Delayed Cleft Treatment

Predictor Variable	Adjusted OR	95% CI	P
Isolated cleft palate	21.721	4.17–113.12	<0.001*
Distance to care center, per 1 km	1.012	1.003–1.021	0.007*
No formal education	8.609	0.68–108.89	0.096

^*Statistically significant at P < 0.05.

Fig. 2.

Type of cleft deformity based on the timing of surgery.

Geographic access was also significant. Greater distance to a cleft care center increased the odds of delay by 1.2% per kilometer (per kilometer increase: AOR = 1.012; 95% CI, 1.003–1.021; P = 0.007). Lack of parental or caregiver education showed a strong but borderline association with delayed treatment (AOR = 8.61; 95% CI, 0.68–108.89; P = 0.096).

DISCUSSION

This study identified key factors associated with delayed surgical treatment of CLP at a major referral center in Ethiopia. The findings demonstrate both alignment with global trends and unique context-specific determinants.

Isolated cleft palate was the strongest independent predictor of delay (AOR = 21.72; P < 0.001), consistent with findings by Eshete et al,⁵ where 74.64% of cleft palate cases were treated beyond the recommended age. However, this contrasts with studies reporting higher delays among more complex or syndromic cases.¹⁰ The delayed treatment observed in patients with isolated cleft palate may be multifactorial. First, the concealed nature frequently leads to late diagnosis, with many cases only identified during evaluation for feeding difficulties or recurrent middle ear infections. In addition, low weight may be present at diagnosis, which further delays surgery, as patients require nutritional rehabilitation and repeated follow-up before being fit for surgery. Second, care-seeking urgency among care givers may be lower for isolated cleft palate, as the lack of visible deformity diminishes the perceived immediacy of intervention.

Greater distance to a cleft care center was also an independent predictor of delay (AOR = 1.012/km; P = 0.007), consistent with studies from Vietnam, Brazil, and California.^1,4,8 Given that approximately 79% of the Ethiopian population resides in rural areas,² geographic barriers likely play a major role. Travel distance, cost, and poor infrastructure contribute to delayed access to specialized care.

Several factors reported in other studies were not found to be significant in this analysis. Socioeconomic status, although associated with delay elsewhere,^12,13,15,16 was not an independent predictor. Similarly, gender was not associated with delay, consistent with some studies^9,11 but contrasting others.^5,8,10

Parental education, although not statistically significant, showed a strong association with delayed treatment (AOR = 8.61; P = 0.096), consistent with previous findings.^8,12 Other health system factors, including insurance coverage and awareness variables, were not significant independent predictors in our study.

CONCLUSIONS AND RECOMMENDATIONS

Delayed cleft treatment in this cohort was primarily associated with the specific type of cleft defect and geographical access. Notably, an isolated cleft palate and greater distance from specialized centers significantly increased the likelihood of delayed surgery.

To address these barriers, the following interventions are recommended:

1. Enhance early detection of isolated cleft palate: Routine, comprehensive oral examination with a checklist should be integrated into newborn assessment at all tiers of healthcare. Providing training to frontline providers will improve early diagnosis, nutritional support, and timely referral.

2. Optimizing geographic access and referral pathways: Access to specialized care facilities should be expanded to regional centers through structural decentralization, workforce training, and establishment of dedicated cleft units. Until permanent regional capacity is achieved, surgical outreach programs should be upscaled and formal referral pathways must be strengthened.

3. Implement targeted awareness initiatives: Culturally adapted public health campaigns and healthcare worker education programs are essential to improve community recognition of cleft conditions and emphasize the importance of timely surgical treatment.

Implementing these strategies may improve equity in access to care and long-term health outcomes for individuals with orofacial clefts in Ethiopia.

Limitations

This single-center study may have limited generalizability. The retrospective design introduces potential recall bias from telephone interviews, and unmeasured confounders, such as sociocultural factors and travel logistics, were not assessed. Despite these limitations, the study provides important insights into modifiable factors contributing to delayed cleft treatment.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.

ETHICAL APPROVAL

Ethical clearance was obtained from the Departmental Research Ethics Committee of Department of Surgery, Addis Ababa University (meeting no.: DOS/REU/183/25/18).

Supplementary Material

gox-14-e8187-s001.pdf ^{(194.8KB, pdf)}