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      Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

      research-article
      1 , 1 , , 2 , 3 , 4 , 5 , 4 , 6 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 3 , 4 , 10 , 13 , 14 , 15 , 16 , 17 , 17 , 18 , 9 , 16 , 18 , 12 , 7 , 13 , 19 , 19 , 8 , 15 , 1
      Trials
      BioMed Central
      Acute appendicitis, Complex appendicitis, Antibiotic prophylaxis, .

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          Abstract

          Background

          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.

          Methods

          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 ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed.

          Discussion

          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.

          Trial registration

          Dutch Trial Register, NTR6128. Registered on 20 December 2016.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2629-0) contains supplementary material, which is available to authorized users.

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          Most cited references43

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          • Abstract: found
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          The epidemiology of appendicitis and appendectomy in the United States.

          To describe the epidemiology of appendicitis and appendectomy in the United States, the authors analyzed National Hospital Discharge Survey data for the years 1979-1984. Approximately 250,000 cases of appendicitis occurred annually in the United States during this period, accounting for an estimated 1 million hospital days per year. The highest incidence of primary positive appendectomy (appendicitis) was found in persons aged 10-19 years (23.3 per 10,000 population per year); males had higher rates of appendicitis than females for all age groups (overall rate ratio, 1.4:1). Racial, geographic, and seasonal differences were also noted. Appendicitis rates were 1.5 times higher for whites than for nonwhites, highest (15.4 per 10,000 population per year) in the west north central region, and 11.3% higher in the summer than in the winter months. The highest rate of incidental appendectomy was found in women aged 35-44 years (43.8 per 10,000 population per year), 12.1 times higher than the rate for men of the same age. Between 1970 and 1984, the incidence of appendicitis decreased by 14.6%; reasons for this decline are unknown. A life table model suggests that the lifetime risk of appendicitis is 8.6% for males and 6.7% for females; the lifetime risk of appendectomy is 12.0% for males and 23.1% for females. Overall, an estimated 36 incidental procedures are performed to prevent one case of appendicitis; for the elderly, the preventive value of an incidental procedure is considerably lower.
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            Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management.

            Acute appendicitis is one of the most common abdominal emergencies worldwide. The cause remains poorly understood, with few advances in the past few decades. To obtain a confident preoperative diagnosis is still a challenge, since the possibility of appendicitis must be entertained in any patient presenting with an acute abdomen. Although biomarkers and imaging are valuable adjuncts to history and examination, their limitations mean that clinical assessment is still the mainstay of diagnosis. A clinical classification is used to stratify management based on simple (non-perforated) and complex (gangrenous or perforated) inflammation, although many patients remain with an equivocal diagnosis, which is one of the most challenging dilemmas. An observed divide in disease course suggests that some cases of simple appendicitis might be self-limiting or respond to antibiotics alone, whereas another type often seems to perforate before the patient reaches hospital. Although the mortality rate is low, postoperative complications are common in complex disease. We discuss existing knowledge in pathogenesis, modern diagnosis, and evolving strategies in management that are leading to stratified care for patients.
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              Trial of short-course antimicrobial therapy for intraabdominal infection.

              The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics. The appropriate duration of antimicrobial therapy remains unclear.
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                Author and article information

                Contributors
                a.vandenboom@erasmusmc.nl
                e.dewijkerslooth@erasmusmc.nl
                j.vanrosmalen@erasmusmc.nl
                f.beverdam@franciscus.nl
                e.boerma@zuyderland.nl
                m.a.boermeester@amc.uva.nl
                a.bosmans@zuyderland.nl
                ta.burghgraef@meandermc.nl
                ecj.consten@meandermc.nl
                idawson@ysl.nl
                j.w.t.dekker@rdgg.nl
                marloes.emous@znb.nl
                avangeloven@tergooi.nl
                go@antoniusziekenhuis.nl
                l.heijnen@nwz.nl
                s.huisman@franciscus.nl
                d.jeanpierre@zuyderland.nl
                jdejonge@tergooi.nl
                j.kloeze@mst.nl
                koopmanschap@eshpm.eur.nl
                h.langeveld@erasmusmc.nl
                misha.luyer@catharinaziekenhuis.nl
                d.melles@erasmusmc.nl
                j.mouton@erasmusmc.nl
                ploega@maasstadziekenhuis.nl
                floris.poelmann@znb.nl
                jeroen.ponten@catharinaziekenhuis.nl
                rossemc@maasstadziekenhuis.nl
                w.h.schreurs@nwz.nl
                jshapiro@ysl.nl
                p.steenvoorde@mst.nl
                br.toorenvliet@ikazia.nl
                j.verhelst@ikazia.nl
                h.versteegh@rdgg.nl
                r.wijnen@erasmusmc.nl
                b.wijnhoven@erasmusmc.nl
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                2 May 2018
                2 May 2018
                2018
                : 19
                : 263
                Affiliations
                [1 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Surgery, , Erasmus MC – University Medical Centre Rotterdam, ; PO Box 2040, 3000 CA Rotterdam, The Netherlands
                [2 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Biostatistics, , Erasmus MC – University Medical Centre, ; Rotterdam, The Netherlands
                [3 ]Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands
                [4 ]Department of Surgery, Zuyderland MC, Sittard/Heerlen, The Netherlands
                [5 ]ISNI 0000000404654431, GRID grid.5650.6, Department of Surgery, Academisch Medisch Centrum, ; Amsterdam, The Netherlands
                [6 ]ISNI 0000 0004 0368 8146, GRID grid.414725.1, Department of Surgery, Meander MC, ; Amersfoort, The Netherlands
                [7 ]ISNI 0000 0004 0501 4532, GRID grid.414559.8, Department of Surgery, IJsselland Ziekenhuis, ; Capelle a/d IJssel, The Netherlands
                [8 ]ISNI 0000 0004 0624 5690, GRID grid.415868.6, Department of Surgery, Reinier de Graaf Gasthuis, ; Delft, The Netherlands
                [9 ]Department of Surgery, MC Leeuwarden, Leeuwarden, The Netherlands
                [10 ]ISNI 0000 0004 0626 2490, GRID grid.413202.6, Department of Surgery, Tergooi, ; Hilversum/Blaricum, The Netherlands
                [11 ]ISNI 0000 0004 0622 1269, GRID grid.415960.f, Department of Surgery, St. Antonius Ziekenhuis, ; Nieuwegein, The Netherlands
                [12 ]Department of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands
                [13 ]ISNI 0000 0004 0399 8347, GRID grid.415214.7, Department of Surgery, Medisch Spectrum Twente, ; Enschede, The Netherlands
                [14 ]ISNI 0000000092621349, GRID grid.6906.9, Erasmus School of Health Policy and Management, , Erasmus University, ; Rotterdam, The Netherlands
                [15 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Pediatric Surgery, , Erasmus MC – University Medical Centre, ; Rotterdam, The Netherlands
                [16 ]ISNI 0000 0004 0398 8384, GRID grid.413532.2, Department of Surgery, Catharina Ziekenhuis, ; Eindhoven, The Netherlands
                [17 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Medical Microbiology and Infectious Diseases, , Erasmus MC – University Medical Centre, ; Rotterdam, The Netherlands
                [18 ]ISNI 0000 0004 0460 0556, GRID grid.416213.3, Department of Surgery, Maasstad Ziekenhuis, ; Rotterdam, The Netherlands
                [19 ]Department of Surgery, Ikazia Ziekenhuis, Rotterdam, The Netherlands
                Article
                2629
                10.1186/s13063-018-2629-0
                5932884
                29720238
                469e49b6-4b42-4056-83bf-dc64832a65c2
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 8 February 2018
                : 4 April 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001826, ZonMw;
                Award ID: Project number 848015008
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                acute appendicitis,complex appendicitis,antibiotic prophylaxis,.
                Medicine
                acute appendicitis, complex appendicitis, antibiotic prophylaxis, .

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