Academic Journal
2 days versus 5 days of postoperative antibiotics for complex appendicitis:a pragmatic, open-label, multicentre, non-inferiority randomised trial
| العنوان: | 2 days versus 5 days of postoperative antibiotics for complex appendicitis:a pragmatic, open-label, multicentre, non-inferiority randomised trial |
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| المؤلفون: | de Wijkerslooth, Elisabeth M.L., Boerma, Evert Jan G., van Rossem, C. C.(Charles), van Rosmalen, J. (Joost), Baeten, Coen I.M., Beverdam, F. H.(Frederique), Bosmans, Johanna W.A.M., Consten, Esther C.J., Dekker, Jan Willem T., Emous, M. (Marloes), van Geloven, Anna A.W., Gijsen, Anton F., Heijnen, L. A.(Luc), Jairam, An P., Melles, D. C.(Damian), van der Ploeg, Augustinus P.T., Steenvoorde, P. (Pascal), Toorenvliet, B. R.(Boudewijn), Vermaas, M. (Maarten), Wiering, Bas, Wijnhoven, Bas P.L., van den Boom, A. L.(Anne Loes), Baeten, C. I.M.(Coen), Boerma, E. G.(Evert Jan), Bosmans, J. W.A.M.(Anne Claire), Burghgraef, T. A.(Thijs), van Geloven, A. A.W.(Nanette), Gijsen, A. F.(Anton), Heinink, F. (Floor), Huisman, S. A.(Sander), Jairam, A. P.(An), Janssen, P. T.J.H.M.(Paul), de Jonge, J. (Joske), Jou-Valencia, D. (Daniela), Klaphake, S. (Sanne), Kloeze, J. (Jurian), Kroese, L. F.(Leonard), Langeveld, H. R.(Hester), Luyer, M. D.P.(Misha), Noordman, B. J.(Bo), van der Ploeg, A. P.T.(Stijn), Poelmann, F. B.(Floris) |
| المصدر: | APPIC Study Group , de Wijkerslooth , E M L , Boerma , E J G , van Rossem , C C , van Rosmalen , J , Baeten , C I M , Beverdam , F H , Bosmans , J W A M , Consten , E C J , Dekker , J W T , Emous , M , van Geloven , A A W , Gijsen , A F , Heijnen , L A , Jairam , A P , Melles , D C , van der Ploeg , A P T , Steenvoorde , .... |
| سنة النشر: | 2023 |
| المجموعة: | University of Groningen research database |
| الوصف: | Background: The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. Methods: In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946. Findings: Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI −1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| DOI: | 10.1016/S0140-6736(22)02588-0 |
| الاتاحة: | https://hdl.handle.net/11370/1d96220d-42da-4976-ae4a-c71fccb13264 https://research.rug.nl/en/publications/1d96220d-42da-4976-ae4a-c71fccb13264 https://doi.org/10.1016/S0140-6736(22)02588-0 https://pure.rug.nl/ws/files/839810855/2_days_versus_5_days_of_postoperative_antibiotics_for_complex_appendicitis-_a_pragmatic_open-label_multicentre_noninferiority_randomised_tria.pdf http://www.scopus.com/inward/record.url?scp=85147372513&partnerID=8YFLogxK |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.67F51A01 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S0140-6736(22)02588-0 |
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