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Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

ABSTRACT: Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy.Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate.Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/?L (range 6,200 to 23,100/?L), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group.A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.

SUBMITTER: Talan DA

PROVIDER: S-EPMC5616169 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

Talan David A DA Saltzman Darin J DJ Mower William R WR Krishnadasan Anusha A Jude Cecilia M CM Amii Ricky R DeUgarte Daniel A DA Wu James X JX Pathmarajah Kavitha K Morim Ashkan A Moran Gregory J GJ

Annals of emergency medicine 20161211 1

<h4>Study objective</h4>Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy.<h4>Methods</h4>Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were random ...[more]

PMID: 27974169

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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.

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:Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days.Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ? 0.025). Both per-protocol and intention-to-treat analyses will be performed.This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly.Dutch Trial Register, NTR6128 . Registered on 20 December 2016.

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Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

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Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

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