Ultrasonographic Appendix Diameter: A Predictive Factor for Non-Operative Treatment of Acute Appendicitis in Pediatrics

doi:10.21203/rs.3.rs-5205121/v1

Background: Nonoperative treatment of acute appendicitis (NOTA) has been demonstrated to be a safe and effective approach in children, but when it fails can be associated with serious morbidity. Since 2012, our department has implemented NOTA as an option for uncomplicated cases of appendicitis.

Objective: We aim to analyse NOTA efficacy and safety and seek predictive factors for the success of this approach, enhancing patient selection.

Methods: Data from all patients with uncomplicated acute appendicitis who underwent NOTA between 2012 and 2022 were collected and analysed. Patients with complicated appendicitis, appendiceal mass, intraluminal appendicolith or inability to oral feed were excluded. NOTA failure was defined as no clinical improvement during treatment. Appendicitis recurrence was defined as a new acute appendicitis onset. Patients were divided into two groups: Successful versus Failure NOTA.

Results: A total of 114 patients were included. NOTA was successful in 89.5% of cases and failed in 10.5%. In the failure NOTA group (n=12) the ultrasonographic appendiceal diameter was significantly higher (p<0.001). A multivariable logistic regression analysis pointed the appendiceal diameter as a significant predictor of NOTA failure, with a cut-off of 8.6 mm obtained after a ROC curve analysis. The hospitalization length admission of the patients from the Failed NOTA group was significantly higher (median time of 4.5 days).

Conclusion: The criterion identified in this study—appendiceal size as measured by ultrasonography—may help minimize some of the failures and the associated morbidity in patients approached by NOTA.

During the 19th century, advancements in areas such as anesthesiology and antibiotherapy paved the way for the surgical technique to remove the appendix, which progressively became the gold standard treatment for acute appendicitis[1]. These developments, over time, significantly improved the outcomes of appendectomies. The introduction of laparoscopy further revolutionized the field, with laparoscopic appendectomy now considered one of the safest surgical procedures, boasting the lowest complication rates among comparable surgeries [2–4].

Acute appendicitis accounts for over 10% of pediatric admissions at the emergency department [3]. Traditionally, surgical intervention has been the preferred treatment. Numerous studies have demonstrated the safety and effectiveness of nonoperative approaches in cases of uncomplicated appendicitis in the adult population, and recently, the same findings were corroborated in children and adolescents, with success rates ranging from 65 to 95%. This alternative treatment avoids the need for abdominal surgery and general anesthesia, thereby mitigating possible perioperative and postoperative complications. Moreover, nonoperative treatment reduces the number of disability days, reducing the patient's overall recovery process [5–17].

Since 2012, our department implemented nonoperative treatment of acute appendicitis (NOTA) as an alternative option for uncomplicated cases of appendicitis. Through this study, the authors aim to analyze the efficacy and safety of NOTA thoroughly and additionally seek to identify predictive factors for its success, aiming to improve patient selection and outcomes for those undergoing this treatment. By enhancing patient selection, we hope to ensure that individuals most likely to benefit from NOTA are accurately identified and treated accordingly.

Data were collected for all pediatric patients with acute appendicitis suspicion admitted to our Pediatric Surgery department between 2012 and 2022. This study retrospectively reviewed the patients with acute appendicitis confirmed by ultrasonography and treated by the NOTA approach. The Institutional Ethical Standards Committee on Health Sciences Investigation and the Data Protection Commission Committee approved this study (REF.195.2019; DPO.20190194_CirPediatrica131119).

Nonoperative treatment of Acute Appendicitis

The nonoperative treatment (NOTA) was proposed for patients with uncomplicated acute appendicitis confirmed by ultrasonography as an alternative to surgery, with the patient and their family's consent. The exclusion criteria for this approach were ultrasonographic findings of intraluminal appendicolith, inability to oral feed, and clinical and ultrasonographic signs of complications, such as clinical evidence of peritonitis, ultrasound evidence of appendiceal perforation, fluid collection, or appendiceal mass.

The NOTA protocol implemented was based on intravenous amoxicillin and clavulanic acid (90–150 mg/kg dosage per day of amoxicillin) under medical surveillance for 48 hours if there were no contraindications. Once there was clinical improvement, with adequate pain control and feeding tolerance, the treatment switched to oral amoxicillin and clavulanic acid (50 mg/kg dosage per day of amoxicillin) for five days, and discharge was allowed.

NOTA success, Failure and Appendicitis Recurrence definitions

NOTA success was defined as clinical improvement and resolution of appendicitis after endovenous and per os antibiotic treatment. No blood or ultrasonographic control was requested to assess the success.

NOTA failure was defined as no clinical improvement during nonoperative antibiotic treatment (persistent abdominal pain and tenderness, persistent or new feverish onset). Additionally, blood samples or ultrasonography can be used, but not by routine.

Appendicitis recurrence was defined as a new acute appendicitis onset, with ultrasonographic confirmation, two months, six months, and one year after NOTA. Although there is no standardizing practice in the department, the possibility of interval laparoscopic appendectomy could be discussed with patients and families during outpatient consultation if they desire. Appendicitis recurrence rate was then presented as the number of patients presenting new acute appendicitis onset after NOTA, considering all patients with no appendectomy performed at the time mentioned.

In case of NOTA failure or appendicitis recurrence, patients were proposed for laparoscopic appendectomy.

Data Analysis

Patients were divided into two groups according to treatment outcome: successful versus failure NOTA groups. Demographics, clinical details, ultrasonography, and blood analyses were analyzed and compared.

All data were retrospectively collected and analyzed using SPSS version 28. In cases of normal distribution, the mean and standard deviation were presented. If the normality test (Shapiro-Wilk test) was violated, the median and interquartile range (IQ) were assessed. Frequency tables were calculated for categorical variables. Comparisons between groups were conducted using the Chi-Square or Fisher’s exact test. The Student t-test was used to compare quantitative variables with normal distribution. Statistical differences were considered significant if the p-value was less than 0.05.

A multivariable logistic regression analysis was performed, respecting the collinearity variables measurement (VIF), with a VIF value greater than 1500 defined as an exclusion criterion. A Receiver Operating Characteristic (ROC) curve analysis and Youden Index were performed on variables with statistically significant associations in the multivariable logistic regression analysis.

Within 892 patients with diagnosis of acute appendicitis, 493 were non complicated. Amongst them there was ultrasonographic evidence of intraluminal appendicolith in 136 cases, which precluded NOTA. Also, there were 231 cases in which the surgeon on call decided to perform surgical treatment (due to non adherence to the NOTA protocol or socioeconomic family issues) or performed other nonoperative treatment regimens.

NOTA was proposed to 126 patients (14% of all acute appendicitis treated in our department during that period). Twelve patients were not included in the study: i) in Eleven cases the patient's parents/legal guardians did not consent NOTA, and the patients were submitted to laparoscopic appendectomy; ii) One case did not complete treatment due to parents’ decision.

A total of 114 patients who underwent NOTA were analyzed. Mean age at the time of treatment was 9.8±3.2 years old. There was a male predominance (64%). During emergent evaluation, all patients presented with right lower abdominal pain and Blumberg sign (n=97; 85.1%). Nausea or vomiting was reported in more than half of the cases (n=62; 54.4%); less than 20% of patients reported fever, dysuria, and other voiding symptoms. Medical evaluation was sought after a median of 24 hours of symptoms. The majority of the patients had changes in inflammatory blood markers, and all had ultrasound findings suggestive of acute appendicitis. The ultrasonographic appendiceal diameter was measured and reported with a mean of 8.0±1.3 mm. The average follow-up time for these patients was 48.3±23.1 months.

Data was then analyzed in the two groups (Table 1). NOTA success rate was 89.5% (n=102). There was no significant difference between both groups regarding patients' demographic and clinical characteristics. Regarding blood markers and radiological findings, only the ultrasonographic appendiceal diameter and hospitalization length were statistically larger in the NOTA failure group (p<0.001).

In the failure NOTA group, most patients (n=11; 91.7%) had no clinical improvement during hospital stay, while 1 (8.8%) had clinical deterioration after discharge on oral medication. These patients underwent laparoscopic appendectomy and were in the hospital with a median of 4.5 days. Three patients (25.0%) had perforated appendicitis. No intra- or postoperative complications were reported, such as incisional wound infections, postoperative abscesses, or peritonitis.

Table 1. Comparison of Successful and Failure NOTA groups, regarding demographics, clinical, laboratory, and radiological parameters.

	*Successful NOTA* *(n=102)*	*Failure NOTA* *(n=12)*	*p-value*
Age (years)	9.6±3.2	11.2±2.9	0.114^a
Gender (male)	65.7% (67)	60.0% (6)	0.345^c
Time since onset of symptoms (hours)	22.4±16.4	30.0±17.4	0.133^a
Clinical Evaluation

Fever	16.7% (17)	16.7% (2)	-
Nausea and vomiting	52.9% (54)	66.7% (8)	0.542^c
Genito-urinary associated symptoms	8.8% (9)	8.3% (1)	0.955^d
Abdominal tenderness	8.8% (9)	0	0.594^c
Blumberg sign	86.3% (88)	75.0% (9)	0.480^c

Inflammatory Blood Markers
Leukocytosis	62.4% (63)	75.0% (9)	0.531^c
Leukocytes (10³/uL)	14.3±4.6	15.0+3.6	0.615^a
C-reactive protein elevation	69.3% (70)	75.0% (9)	0.684^d
C-reactive protein (mg/L)	22.9±34.5	23.6§34.7	0.943^a

Ultrasonographic Parameters
Appendix Diameter (mm)	7.9±1.2	9.6±1.2	<0.001^a
Hiper-echogenicity Periapendicular Fat	88.1% (89)	100% (12)	0.357^c

Hospital length of stay (days)	2 IQ 1	4.5 IQ 2.5	p<0.001^b

Interval Appendectomy	19.6% (20/102)	-

Appendicitis Recurrence
Appendicitis recurrence at 2 months (%, n)	5.9% (6/102)
Appendicitis recurrence at 6 months (%, n)	7.0% (6/95)	-
Appendicitis recurrence at 12 months (%, n)	10.4% (8/77)	-

Urgent Laparoscopic Appendectomy	7.8% (8)	100% (12)
Perforated Appendicitis	1.3% (1)	25.0% (3)
Intraoperative complications	0%	0%
Postoperative complications	0%	0%

In the NOTA success group, 7% (n=6) of patients had recurrent appendicitis within six months and 10.4% (n=8) within 12 months. All had laparoscopic appendectomy performed, and only 1.3% had perforated appendicitis; for all the postoperative period was uneventful. In twenty cases (19.6%) of patients opted for an elective laparoscopic appendectomy during follow-up, primarily due to parents' anxiety or recurrent abdominal pain without evidence of appendicitis. In those, the anatomopathological studies were normal. The follow-up time was not significantly different between the groups (p=0.235).

A multivariable logistic regression analysis was performed considering demographics, laboratory, and radiological parameters. An association between the ultrasonographic appendiceal diameter and NOTA failure was identified (p=0.001) (Table 2). Since the appendiceal diameter was reported as a significant predictor of NOTA failure, a ROC curve analysis was performed and an 8.6 mm appendiceal diameter cut-off was obtained (Youden's J) with a sensitivity of 63.2% and 77.9% of specificity (p<0.001) (Figure 1).

Table 2. Multivariable logistic regression analysis to Successful NOTA, considering demographics, laboratory, and radiological parameters.

	*p-value*	*Odd Ratio (OR)*	*95% CI for OR*
	*p-value*	*Odd Ratio (OR)*	*Lower*	*Upper*
Age (years)	0.369	0.896	0.706	1.138
Gender (female)	0.523	0.586	0.116	2.996
Time since onset of symptoms (hours)	0.084	0.963	0.932	1.005
Clinical Evaluation

Fever	0.643	0.605	0.072	5.065
Genito-urinary associated symptoms	0.349	5.169	0.166	160.227
Nausea /Vomiting	0.433	0.505	0.092	2.781
Abdominal tenderness	0.999	-	-	-
Blumberg sign	0.311	3.29	0.345	28.393

Inflammatory Blood Markers
Leukocytosis	0.239	0.316	0.047	2.149
C-reactive protein elevation	0.459	2.006	0.318	12.636

Ultrasonographic Parameters
Appendix Diameter (mm)	0.001	0.422	0.248	0.719
Hiper-echogenicity Periapendicular Fat	0.999	-	-	-

Logistic Regression analysis with R² Nagerlkerke = 0.412; _X2 (12) = 25.457, p=0.013. Hosmer and Lemeshow = 1.489, 8df p=0.993.

Collinearity variables measurements (VIF) under 1.500.

Acute appendicitis is one of the most frequent diagnosis in pediatric emergency services. Although the surgical approach has been the consensual gold-standard treatment [5, 6], nonoperative treatment has been safely applied in uncomplicated appendicitis cases, with no inferior outcomes in the resolution of acute appendicitis, avoiding surgical and anesthetic risks. However, as the appendix remains, this approach cannot prevent the risk of an appendicitis recurrence in the future, as it has been described increases over time. [7, 9, 10, 12–14, 16 18–24]

In 2012, our department introduced nonoperative treatment for acute appendicitis as an alternative option for uncomplicated cases. Over several years, NOTA has been implemented in patients with no clinical or radiological signs of complications, excluding cases with intraluminal appendicolith. In this study, about 55.3% of acute appendicitis cases were reported as uncomplicated; of those, 12.8% were included in the analysis. Accurate differentiation between complicated and uncomplicated acute appendicitis is essential to optimize the efficiency of nonoperative treatment [25]. The combination of clinical manifestation and radiological studies has made this distinction increasingly safe and precise, although sometimes, it may be uncertain before surgical intervention. Typically, uncomplicated appendicitis has a recent onset (< 48 hours), a relatively higher white blood cell count (< 18,000/µL), and the radiological absence of peritonitis, abscess, phlegmon, or fluid collection [11, 12, 26, 27]. Although the onset of symptoms was recorded in this study, it was not considered in patient selection, and there were no age limitations or specific blood inflammatory markers. Despite that, our sample's clinical characteristics resembled the definition of uncomplicated cases, with no statistical differences between cases of successful and failed NOTA.

Around 15% of all acute appendicitis cases were excluded from the analysis due to the presence of intraluminal appendicolith in ultrasonography. The association between appendicolith and nonoperative treatment failure and appendicitis recurrence has been described by several authors, and also, a prospective study by Machida et al.[27] reported an unacceptable failure rate of about 60% in children with uncomplicated appendicitis with appendicolith [7, 8, 22, 27–29]. Appendicolith is known to cause appendicitis by leading to the obstruction of the appendix lumen, which may be a physical impediment to resolving the infectious process. Nonoperative treatment is based on antibiotics to resolve the infection, but the blockage in the appendix lumen may hinder the therapy's success. Therefore, this study did not include patients with intraluminal appendicolith, even with uncomplicated acute appendicitis.

Our study reported a NOTA success rate of 89.5%, and twelve patients experienced NOTA failure. These findings align with literature reports, which indicate a nonoperative treatment success rate ranging from 87–97% and an average of 8–17% hospital failures, considering NOTA as a feasible option for uncomplicated appendicitis in children [7, 28, 30]. Additionally, a 2017 meta-analysis [25] reported antibiotic treatments in pediatric patients with uncomplicated appendicitis as feasible and effective without increasing the risk of complications, suggesting it should be considered for selected patients. This study reinforces the safety and feasibility of the NOTA approach in children with uncomplicated acute appendicitis as an alternative to surgery.

The concern of perforation, intra-abdominal abscess, or peritonitis due to surgery postponement or revocation has been discussed in the literature. Several studies have reported a 0-9.6% range of perforation rates with no further complications in pediatric nonoperative treatment [14, 19, 20, 31, 32]. In our study, a total of 3 patients (2.6% of all) of the unsuccessful group were diagnosed with perforated appendicitis, leading the authors to hypothesize that these cases may have been misapplied NOTA. Besides that, no intraoperative or postoperative complications were reported in these patients.

In the authors' opinion, considering NOTA as a resolutive treatment for acute appendicitis, the recurrence rate after this approach should be close to the appendicitis rate of the general population per year, which is about 5.7–50 patients per 100,000 inhabitants per year, also reported as a lifetime risk of around 9% [4]. Several articles have reported recurrence rates ranging from 16–28% at 1-year follow-up [10, 11, 13, 21, 27], with a meta-analysis accounting for a 16.1% recurrence rate, confirmed by histopathologic examination at 1-year follow-up. Another study by Patkova et al. [32] reported that most patients recurred in the first two months of follow-up, with most recurrences occurring within the first year of vigilance. In our study, there was a 10.3% recurrence rate over one year of follow-up, with most cases occurring at two months of follow-up. Considering this analysis, our study reported a recurrence rate similar to what has been described in the literature, still far from the original population appendicitis risk.

As improving NOTA outcomes is a priority for our department to minimize patient morbidity, avoid prolonging the best treatment option, and reduce the length of hospital stay, patient selection for NOTA must be improved for the highest success of this therapy. A 2023 prospective study reported a higher success rate in nonoperative treatment success in patients with short duration of symptoms, low leukocyte count, and smaller appendix size on ultrasound [31]. Also, Brecker G. et al., in 2024 [33], reported a high failure rate in patients older than 14 years old. In this study, the authors sought to identify predictive factors for the success of this therapy to enhance patient selection. After finding statistical differences in appendix diameter between the success and failure NOTA groups, a multivariable logistic regression analysis revealed an association between ultrasonographic appendiceal diameter and NOTA failure, with an 8.6 mm appendiceal diameter cut-off. According to these findings, appendix diameter negatively influences the success rate of nonoperative treatment in uncomplicated appendicitis. The wider the diameter, the greater the risk of failure, making surgery a preferable option in patients with uncomplicated appendicitis and an appendix diameter over 8.6mm. The authors hypothesize that by adding this exclusion criterion in NOTA patient selection, the failure rate could be reduced, improving clinical results for this treatment.

One of the advantages of the NOTA approach is the avoidance of surgery, and the role of interval appendectomy after a successful nonoperative treatment for uncomplicated appendicitis is unknown. Some authors have reported that nonoperative management without interval appendectomy is the most cost-effective strategy in children [20, 34]. A systematic review of complicated appendicitis presented the risk of recurrence as similar to the risk for morbidity associated with interval appendectomy. In our study, a total of 20% of patients chose to perform an interval appendectomy, primarily due to recurrent abdominal symptoms or parental request, with no evidence of appendicitis in histologic examination. Although acute appendicitis could rarely be an inaugural presentation of an underlying malignancy in about 0.5% of children [14, 35], this study suggests that appendectomy should only be a backup intervention in case of recurrence or as requested by the patient's family.

A significant limitation of this study is the non-randomized and retrospective nature, which may introduce sampling bias and the possibility of missing data in the medical records during follow-up. Additionally, there was no control group analysis, with uncomplicated appendicitis submitted to appendectomy, making approach comparisons impossible.

In our department's early stages of NOTA implementation, antibiotic therapy choices were not standardized, and different combinations were used. To reduce bias in the results, the authors excluded these cases from the analysis, reducing the sample size and consequently changing the strength of the results.

This work appears to be the first to assess the ultrasonographic appendix diameter as a negative predictor of NOTA success, establishing an 8.6mm cut-off value for appendix diameter in the application of NOTA in uncomplicated appendicitis cases. Nevertheless, the surgical approach in uncomplicated appendicitis has reported excellent outcomes, with meager rates of intra or postoperative complications. As such, NOTA application, in the author's opinion, should be restricted to inclusive criteria previously mentioned and, more importantly, to ultrasonographic appendix diameter cut-off, and with the family's consent, to achieve better outcomes with the minimum morbidity to patient and patient's family.

Given the findings of this study, it is now pertinent to initiate a prospective, preferably multicenter, study that utilizes appendiceal size assessed by ultrasonography as an inclusion or exclusion criterion. This approach could enhance our understanding of the predictive value of appendiceal size in the non-operative treatment of acute appendicitis. By adopting a standardized measure across multiple centers, we aim to refine patient selection and improve outcomes, ultimately reducing the morbidity associated with treatment failures.

Non-operative treatment of acute appendicitis (NOTA) has emerged as a viable approach for managing pediatric appendicitis. However, in cases where this approach fails, it can result in significant morbidity for the child and their family. Therefore, it is crucial to identify criteria that can accurately predict the likelihood of success. In this context, the criterion identified in this study—appendiceal size as measured by ultrasonography—may help minimize some of the failures and the associated morbidity.

The analysis revealed that the appendix diameter observed in ultrasonography is a crucial predictor of NOTA success. The authors suggest that surgery is more appropriate for patients with uncomplicated appendicitis and an appendix diameter greater than 8.6mm. With this criterion for patient selection, the authors anticipate improving clinical results and reducing comorbidity for NOTA treatment.

Author Contribution

IB - made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; ; drafted the work or revised it critically for important intellectual content;CB- drafted the work or revised it critically for important intellectual content; approved the version to be published; agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolvedSM- drafted the work or revised it critically for important intellectual content; agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolvedRLP- agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolvedAF- drafted the work or revised it critically for important intellectual content; approved the version to be published;JCP- drafted the work or revised it critically for important intellectual content; approved the version to be published;

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No competing interests reported.

Ultrasonographic Appendix Diameter: A Predictive Factor for Non-Operative Treatment of Acute Appendicitis in Pediatrics

Status:

Version 1

Abstract

Figures

INTRODUCTION

METHODS

Nonoperative treatment of Acute Appendicitis

NOTA success, Failure and Appendicitis Recurrence definitions

Data Analysis

RESULTS

DISCUSSION

CONCLUSION

Declarations

Author Contribution

References

Additional Declarations

Status:

Version 1