Association of Initial Treatment With Antibiotics vs Surgery With Treatment Success and Disability in Subgroups of Children With Uncomplicated Appendicitis.
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SUBMITTER: Minneci PC
PROVIDER: S-EPMC8220457 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
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Association of Initial Treatment With Antibiotics vs Surgery With Treatment Success and Disability in Subgroups of Children With Uncomplicated Appendicitis.
Minneci Peter C PC Hade Erinn M EM Metzger Gregory A GA Saito Jacqueline M JM Mak Grace Z GZ Deans Katherine J KJ
JAMA 20210601 24
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Project description:ImportanceNonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.ObjectiveTo 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 participantsMulti-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.InterventionsPatient 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 measuresThe 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.ResultsAmong 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 relevanceAmong 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 registrationClinicalTrials.gov Identifier: NCT02271932.
| S-EPMC7385674 | biostudies-literature
Project description:Non-operative treatment of uncomplicated appendicitis is safe and increasing in popularity, but has other risks and benefits compared with appendicectomy. This study aimed to explore the preference of the general population regarding operative or antibiotic treatment of uncomplicated appendicitis. In this prospective study, a clinical scenario and questionnaire were submitted to a panel comprising a sample of an average adult population. The survey was distributed by an independent, external research bureau, and included a comprehensive explanation of the risks and benefits of both treatment options. The primary outcome was the proportion of participants who would prefer antibiotics over surgery. Secondary outcomes were reasons for this preference and the accepted recurrence rate within 1 year when treated with antibiotics only. All outcomes were weighted for the average Dutch population. Of 254 participants, 49.2 per cent preferred antibiotic treatment for uncomplicated appendicitis, 44.5 per cent preferred surgery, and 6.3 per cent could not make a decision. About half of the participants preferring antibiotics would accept a recurrence risk of more than 50 per cent within 1 year. Avoiding surgery was their main reason. In participants preferring surgery, many tolerated a recurrence risk of no more than 10 per cent when treated with antibiotics. Removal of the cause of appendicitis was their main reason. Around half of the average population sample preferred antibiotics over surgical treatment of uncomplicated appendicitis and were willing to accept a high recurrence risk to avoid surgery initially. Participants who preferred surgery tolerated only a very low recurrence risk with antibiotic treatment.
| S-EPMC8411439 | biostudies-literature
Project description:Importance:Studies have compared surgical with nonsurgical therapy for acute uncomplicated appendicitis, but none of these studies have a patient-centered perspective. Objectives:To evaluate how patients might choose between surgical and nonsurgical therapy for acute uncomplicated appendicitis and to identify targets to make antibiotic treatment more appealing. Design, Setting, and Participants:This study comprised an online survey and an in-person sensitivity analysis survey. For the web survey, a convenience sample of 1728 respondents were asked to imagine that they or their child had acute uncomplicated appendicitis, provided information about laparoscopic and open appendectomy and antibiotic treatment alone, and asked which treatment they might choose. The web survey was open from April 17, 2016, through June 16, 2016, and was disseminated via email link, a poster with a Quick Response code, and social media. For the sensitivity analysis, 220 respondents were given the same scenario and options. Those who chose surgery were asked whether certain factors influenced their decision; each factor was incrementally improved during questioning about whether respondents would consider switching to antibiotics. These participants were recruited at public venues from June 3, 2016, to July 31, 2016. Web survey data were analyzed from June 17, 2016, to September 21, 2017. Sensitivity analysis data were analyzed from August 1, 2016, to September 21, 2017. Main Outcomes and Measures:Treatment preferences. Results:Among the 1728 web survey respondents, 1225 (70.9%) were female and 500 (28.9%) were male (3 [0.2%] either did not answer or responded as "gender fluid" within the comments section of the survey), and most self-reported being between 50 and 59 years of age (391 [22.6%]) and being non-Hispanic white (1563 [90.5%]). For themselves, 1482 respondents (85.8%) chose laparoscopic appendectomy, 84 (4.9%) chose open appendectomy, and 162 (9.4%) chose antibiotics alone. For their child, 1372 respondents (79.4%) chose laparoscopic appendectomy, 106 (6.1%) open appendectomy, and 250 (14.5%) antibiotics alone. Respondents were somewhat more likely to choose antibiotics for themselves if they had education beyond college (105 [12.6%]; P < .001), identified as other than non-Hispanic white (24 [14.9%]; P < .001), or did not know anyone who had previously been hospitalized (12 [15.8%]; P = .02), but they were less likely to choose antibiotics if they were surgeons (11 [5.4%]; P = .008). Of the 220 participants interviewed for the sensitivity analysis, 120 (54.5%) were female and 100 (45.5%) were male, and most self-reported being between 18 and 24 years of age (53 [24.1%]) and being non-Hispanic white (204 [92.7%]). Their responses suggested that improvements in the short- and long-term failure rate of antibiotic treatment-rather than reductions in the duration of hospitalization or antibiotic treatment-were more likely to increase the desirability of choosing antibiotics. Conclusions and Relevance:Most patients may choose surgical intervention over antibiotics alone in treatment of acute uncomplicated appendicitis, but a meaningful number may choose nonoperative management. Therefore, from a patient-centered perspective, this option should be discussed with patients, and future research could be directed at reducing the failure and recurrence rates of antibiotic treatment for appendicitis.
| S-EPMC5875347 | biostudies-literature
Project description:IntroductionIn recent years, there has been growing interest in alternatives to appendicectomy. In particular, non-operative treatment of appendicitis, with antibiotics alone, has been proposed as a potential treatment. A small number of randomised controlled trials (RCTs) in adults and, more recently, children suggest that antibiotic treatment may be a valid alternative to appendicectomy. However, there is currently insufficient data to justify its widespread use. Prior to performing further efficacy studies of the treatment of appendicitis in children, it is imperative to identify the most relevant outcome measures for inclusion in the design of comparative studies. This is of particular importance when evaluating a novel treatment approach since the outcomes of importance may differ from those commonly reported with traditional therapies.A review of the relevant literature and electronic resources failed to identify a core outcome set (COS) for children with appendicitis. We aim to define a COS for the measurement of treatment interventions in children (<18 years) with acute appendicitis.Methods and analysisThis project will entail: (1) a systematic review to identify previously reported acute uncomplicated appendicitis treatment outcomes; (2) assembly of stakeholder panels (paediatric and adult surgeons, patients and parents); (3) a three-stage Delphi process; and (4) a final consensus meeting to complete the COS.Ethics and registrationCOS development is part of CONservative TReatment of Appendicitis in Children - a randomised controlled Trial (Feasibility) (CONTRACT) study, for which full ethical approval for CONTRACT has been granted. The COS development study is registered with the COMET Initiative in May 2017 (http://www.comet-initiative.org/studies/details/987).
| S-EPMC5862231 | biostudies-literature
Project description:ImportanceAppendectomy remains the standard of care for uncomplicated acute appendicitis despite several randomized clinical trials pointing to the safety and efficacy of nonoperative management of this disease. A meta-analysis of randomized clinical trials may contribute to the body of evidence and help surgeons select which patients may benefit from surgical and nonsurgical treatment.ObjectiveTo assess the efficacy and safety of nonoperative management vs appendectomy for acute uncomplicated appendicitis.Data sourcesA systematic review was conducted using indexed sources (Embase and PubMed) to search for published randomized clinical trials in English comparing nonoperative management with appendectomy in adult patients presenting with uncomplicated acute appendicitis. To increase sensitivity, no limits were set for outcomes reported, sex, or year of publication. All nonrandomized or quasi-randomized trials were excluded, and validated primers were used.Study selectionAmong 1504 studies imported for screening, 805 were duplicates, and 595 were excluded for irrelevancy. A further 96 were excluded after full-text review, mainly owing to wrong study design or inclusion of pediatric populations. Eight studies met the inclusion criteria and were selected for the meta-analysis.Data extraction and synthesisMeta-extraction was conducted with independent extraction by multiple reviewers using the Covidence platform for systematic reviews and in accordance with PRISMA guidelines. Data were pooled by a random-effects model.Main outcomes and measuresTreatment success and major adverse effects at 30 days' follow-up.ResultsThe main outcome (treatment success proportion at 30 days of follow-up) was not significantly different in the operative and nonoperative management cohorts (risk ratio [RR], 0.85; 95% CI, 0.66-1.11). Likewise, the percentage of major adverse effects was similar in both cohorts (RR, 0.72; 95% CI, 0.29-1.79). However, in the nonoperative management group, length of stay was significantly longer (RR, 1.48; 95% CI, 1.26-1.70), and a median cumulative incidence of 18% of recurrent appendicitis was observed.Conclusions and relevanceThese results point to the general safety and efficacy of nonoperative management of uncomplicated acute appendicitis. However, this strategy may be associated with an increase in duration of hospital stay and a higher rate of recurrent appendicitis. This meta-analysis may help inform decision-making in nonoperative management of uncomplicated acute appendicitis.
| S-EPMC9330355 | biostudies-literature
Project description:BackgroundPrimary appendectomy is the current standard of care for treating uncomplicated acute appendicitis, but interest in conservative treatment with antibiotics alone has been increasing in recent years. Clinical trials so far have shown controversial results.MethodsA series of meta-analyses were reviewed. Studies comparing surgery versus antibiotics alone for treating uncomplicated acute appendicitis in adults were included. Descriptive statistics and data on treatment effects were retrieved and summarized.ResultsThe conservative approach has a success rate of around 60 % and is associated with shorter pain duration, reduced analgesic medication, faster resolution of the inflammation process, lower expenses and quicker return to work. On the other hand, medical treatment leads to high (up to 20 %) readmission rates and more often requires surgery. An operative approach is associated with higher treatment success rates (>90 %) and very a low mortality rate.ConclusionBased on the current body of evidence, the use of antibiotics for primary treatment of uncomplicated acute appendicitis cannot be routinely recommended. Appendectomy remains the gold-standard treatment.
| S-EPMC4628279 | biostudies-literature
Project description: Not available
| S-EPMC4769928 | biostudies-literature
Project description:BackgroundMeta-analyses and a recent guideline acknowledge that conservative management of uncomplicated appendicitis with antibiotics can be successful for patients who wish to avoid surgery. However, guidance as to specific management does not exist.MethodsPUBMED and EMBASE search of trials describing methods of conservative treatment was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.ResultsThirty-four studies involving 2,944 antibiotic-treated participants were identified. The greatest experience with conservative treatment is in persons 5 to 50 years of age. In most trials, imaging was used to confirm localized appendicitis without evidence of abscess, phlegmon, or tumor. Antibiotics regimens were generally consistent with intra-abdominal infection treatment guidelines and used for a total of 7 to 10 days. Approaches ranged from 3-day hospitalization on parenteral agents to same-day hospital or ED discharge of stable patients with outpatient oral antibiotics. Minimum time allowed before response was evaluated varied from 8 to 72 hours. Although pain was a common criterion for nonresponse and appendectomy, analgesic regimens were poorly described. Trials differed in use of other response indicators, that is, white blood cell count, C-reactive protein, and reimaging. Diet ranged from restriction for 48 hours to as tolerated. Initial response rates were generally greater than 90% and most participants improved by 24 to 48 hours, with no related severe sepsis or deaths. In most studies, appendectomy was recommended for recurrence; however, in several, patients had antibiotic retreatment with success.ConclusionWhile further investigation of conservative treatment is ongoing, patients considering this approach should be advised and managed according to study methods and related guidelines to promote informed shared decision-making and optimize their chance of similar outcomes as described in published trials. Future studies that address biases associated with enrollment and response evaluation, employ best-practice pain control and antibiotic selection, better define cancer risk, and explore longer time thresholds for response, minimized diet restriction and hospital stays, and antibiotic re-treatment will further our understanding of the potential effectiveness of conservative management.Level of evidenceSystematic review, level II.
| S-EPMC6437084 | biostudies-literature
Project description: Not available
| S-EPMC7400192 | biostudies-literature
Project description:ImportanceAntibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known.ObjectiveTo compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis.Design, setting, and participantsThe Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019.InterventionsPatients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by oral levofloxacin (500 mg/d) and metronidazole (500 mg 3 times/d) for 5 days.Main outcomes and measuresThe primary end point was treatment success (≥65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference.ResultsAmong 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin.Conclusion and relevanceAmong adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics.Trial registrationClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.
| S-EPMC7802006 | biostudies-literature