ArticleTrials2018
Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04707339 (Management of Acute Appendicitis at District General Hospital), which is not on this map. Cited by 7 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Management of Acute Appendicitis at District General Hospital
Who cites it
7 citing papers in PubMed, 22 citations in OpenAlex.
- [Critical points to implement an antibiotic form for management of surgical wound infection].Revista medica del Instituto Mexicano del Seguro Social · 2023Observational
- Review
- Variability in hospital costs for short stay emergent laparoscopic appendectomy.Surgery open science · 2022Article
- Retrospective Cohort Analysis of the Effect of Antimicrobial Stewardship on Postoperative Antibiotic Therapy in Complicated Intra-Abdominal Infections: Short-Course Therapy Does Not Compromise Patients' Safety.Antibiotics (Basel, Switzerland) · 2022Article
- Complex And Simple Appendicitis: REstrictive or Liberal postoperative Antibiotic eXposure (CASA RELAX) using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR): study protocol for a randomized controlled trial.Trauma surgery & acute care open · 2022Article
- Postoperative Antibiotics and Time to Reach Discharge Criteria after Appendectomy for Complex Appendicitis.Digestive surgery · 2022Article
- Variation in Classification and Postoperative Management of Complex Appendicitis: A European Survey.World journal of surgery · 2019Article
Corrections and comments
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Authors and funding
36 authors at 17 institutions in 1 country.
Funding
Abstract
backgroundAcute 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.
methodsPatients 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 registrationDutch Trial Register, NTR6128 . Registered on 20 December 2016.
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