Dataset Information

Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis.

ABSTRACT:

Importance

Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.

Objective

To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis.

Design, setting, and participants

Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study.

Interventions

Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698).

Main outcomes and measures

The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments.

Results

Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference.

Conclusion and relevance

Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met.

Trial registration

ClinicalTrials.gov Identifier: NCT02271932.

SUBMITTER: Minneci PC

PROVIDER: S-EPMC7385674 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceUse of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making.ObjectiveTo assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis.Design, setting, and participantsIn this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021.ExposuresAppendectomy vs antibiotics.Main outcomes and measuresConditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons.ResultsOf 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91).Conclusions and relevanceThis cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.

Project description:ImportanceAntibiotic therapy for acute uncomplicated appendicitis is effective in adult patients, but its application in pediatric patients remains controversial.ObjectiveTo compare the safety and efficacy of antibiotic treatment vs appendectomy as the primary therapy for acute uncomplicated appendicitis in pediatric patients.Data sourcesThe PubMed, MEDLINE, EMBASE, and Cochrane Library databases and the Cochrane Controlled Trials Register for randomized clinical trials were searched through April 17, 2016. The search was limited to studies published in English. Search terms included appendicitis, antibiotics, appendectomy, randomized controlled trial, controlled clinical trial, randomized, placebo, drug therapy, randomly, and trial.Study selectionRandomized clinical trials and prospective clinical controlled trials comparing antibiotic therapy with appendectomy for acute uncomplicated appendicitis in pediatric patients (aged 5-18 years) were included in the meta-analysis. The outcomes included at least 2 of the following terms: success rate of antibiotic treatment and appendectomy, complications, readmissions, length of stay, total cost, and disability days.Data extraction and synthesisData were independently extracted by 2 reviewers. The quality of the included studies was examined in accordance with the Cochrane guidelines and the Newcastle-Ottawa criteria. Data were pooled using a logistic fixed-effects model, and the subgroup pooled risk ratio with or without appendicolith was estimated.Main outcomes and measuresThe primary outcome was the success rate of treatment. The hypothesis was formulated before data collection.ResultsA total of 527 articles were screened. In 5 unique studies, 404 unique patients with uncomplicated appendicitis (aged 5-15 years) were enrolled. Nonoperative treatment was successful in 152 of 168 patients (90.5%), with a Mantel-Haenszel fixed-effects risk ratio of 8.92 (95% CI, 2.67-29.79; heterogeneity, P?=?.99; I2?=?0%). Subgroup analysis showed that the risk for treatment failure in patients with appendicolith increased, with a Mantel-Haenszel fixed-effects risk ratio of 10.43 (95% CI, 1.46-74.26; heterogeneity, P?=?.91; I2?=?0%).Conclusions and relevanceThis meta-analysis shows that antibiotics as the initial treatment for pediatric patients with uncomplicated appendicitis may be feasible and effective without increasing the risk for complications. However, the failure rate, mainly caused by the presence of appendicolith, is higher than for appendectomy. Surgery is preferably suggested for uncomplicated appendicitis with appendicolith.

Project description:BackgroundTraditionally, uncomplicated acute appendicitis (AA) has been treated with appendectomy. However, the surgical alternatives might carry out significant complications, impaired quality of life, and higher costs than nonoperative treatment. Consequently, it is necessary to evaluate the different therapeutic alternatives' cost-effectiveness in patients diagnosed with uncomplicated appendicitis.MethodsWe performed a model-based cost-effectiveness analysis comparing nonoperative management (NOM) with open appendectomy (OA) and laparoscopic appendectomy (LA) in patients otherwise healthy adults aged 18-60 years with a diagnosis of uncomplicated AA from the payer´s perspective at the secondary and tertiary health care level. The time horizon was 5 years. A discount rate of 5% was applied to both costs and outcomes. The health outcomes were quality-adjusted life years (QALYs). Costs were identified, quantified, and valorized from a payer perspective; therefore, only direct health costs were included. An incremental analysis was estimated to determine the incremental cost-effectiveness ratio (ICER). In addition, the net monetary benefit (NMB) was calculated for each alternative using a willingness to pay lower than one gross domestic product. A deterministic and probabilistic sensitivity analysis was performed.MethodsWe performed a model-based cost-effectiveness analysis comparing nonoperative management (NOM) with open appendectomy (OA) and laparoscopic appendectomy (LA) in patients otherwise healthy adults aged 18-60 years with a diagnosis of uncomplicated AA from the payer's perspective at the secondary and tertiary health care level. The time horizon was five years. A discount rate of 5% was applied to both costs and outcomes. The health outcomes were quality-adjusted life years (QALYs). Costs were identified, quantified, and valorized from a payer perspective; therefore, only direct health costs were included. An incremental analysis was estimated to determine the incremental cost-effectiveness ratio (ICER). In addition, the net monetary benefit (NMB) was calculated for each alternative using a willingness to pay lower than one gross domestic product. A deterministic and probabilistic sensitivity analysis was performed.ResultsLA presents a lower cost ($363 ± 35) than OA ($384 ± 41) and NOM ($392 ± 44). NOM exhibited higher QALYs (3.3332 ± 0.0276) in contrast with LA (3.3310 ± 0.057) and OA (3.3261 ± 0.0707). LA dominated the OA. The ICER between LA and NOM was $24,000/QALY. LA has a 52% probability of generating the highest NMB versus its counterparts, followed by NOM (30%) and OA (18%). There is a probability of 0.69 that laparoscopy generates more significant benefit than medical management. The mean value of that incremental NMB would be $93.7 per patient.ConclusionsLA is a cost-effectiveness alternative in the management of patients with uncomplicated AA. Besides, LA has a high probability of producing more significant monetary benefits than NOM and OA from the payer's perspective in the Colombian health system.

Project description:ImportanceHealth care professionals have shown significant interest in nonoperative management for uncomplicated appendicitis, but long-term population-level data are lacking.ObjectiveTo compare the outcomes of nonoperatively managed appendicitis against appendectomy.Design, setting, and participantsThis national retrospective cohort study used claims data from a private insurance database to compare patients admitted with uncomplicated appendicitis from January 1, 2008, through December 31, 2014, undergoing appendectomy vs nonoperative management. Coarsened exact matching was applied before multivariate analysis to reduce imbalance between groups. Data were analyzed from February 12 through May 1, 2018.ExposuresAppendectomy (control arm) or nonoperative management (treatment arm).Main outcomes and measuresShort-term primary clinical outcomes included emergency department visits, hospital readmission, abdominal abscess, and Clostridium difficile infections. Long-term primary clinical outcomes were small-bowel obstructions, incisional hernias, and appendiceal cancers. Nonoperative management failure was defined by hospital readmission with appendicitis diagnosis and an appendicitis-associated operation or procedure. Secondary outcomes included number of follow-up visits, length and cost of index hospitalization, and total cost of appendicitis-associated care. Covariates included age, sex, region, insurance plan type, admission year, and Charlson comorbidity index.ResultsOf 58 329 patients with uncomplicated appendicitis (52.7% men; mean [SD] age, 31.9 [16.5] years), 55 709 (95.5%) underwent appendectomy and 2620 (4.5%) underwent nonoperative management. Patients in the nonoperative management group were more likely to have appendicitis-associated readmissions (adjusted odds ratio, 2.13; 95% CI, 1.63-2.77; P < .001) and to develop an abscess (adjusted odds ratio, 1.42; 95% CI, 1.05-1.92; P = .02). Patients in the nonoperative management group required more follow-up visits in the year after index admission (unadjusted mean [SD], 1.6 [6.3] vs 0.3 [1.4] visits; adjusted +1.11 visits; P < .001) and had lower index hospitalization cost (unadjusted mean [SD], $11 502 [$9287] vs $13 551 [$10 160]; adjusted -$2117, P < .001), but total cost of appendicitis care was higher when follow-up care was considered (unadjusted, $14 934 [$31 122] vs $14 186 [$10 889]; adjusted +$785; P = .003). During a mean (SD) of 3.2 (1.7) years of follow-up, failure of nonoperative management occurred in 101 patients (3.9%); median time to recurrence was 42 days (interquartile range, 8-125 days). Among the patients who experienced treatment failure, 44 did so within 30 days.Conclusions and relevanceAccording to results of this study, nonoperative management failure rates were lower than previously reported. Nonoperative management was associated with higher rates of abscess, readmission, and higher overall cost of care. These data suggest that nonoperative management may not be the preferred first-line therapy for all patients with uncomplicated appendicitis.