2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial

Wijkerslooth, Elisabeth M L de; Boerma, Evert-Jan G.; Rossem, Charles C. van; Rosmalen, Joost van; Baeten, Coen I.M.; Beverdam, Frédérique H; Bosmans, Johanna W A M; Consten, Esther C. J.; Dekker, Jan Willem T.; Emous, Marloes; Geloven, A. A. W. van; Gijsen, Anton F.; Heijnen, Luc A.; Jairam, An P.; Melles∗, Damian C.; Ploeg, Augustinus P. T. van der; Steenvoorde, Pascal; Toorenvliet, Boudewijn R.; Vermaas, Maarten; Wiering, B.; Wijnhoven, Bas P. L.; Boom, Anne Loes van den

doi:10.1016/s0140-6736(22)02588-0

Cited by 23 publications

(21 citation statements)

References 45 publications

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“…Oral administration of antibiotics was not associated with an increased risk of postoperative infections when compared with intravenous antibiotic treatment of the same length after laparoscopic appendectomy in complicated appendicitis. The rate of postoperative organ/space SSI in our study was 10% and 9% in intravenous and oral groups, respectively, which is comparable to 7% to 12% observed in the recent literature 4,7,23 . The overall rate of complications was 15% in both study groups, which is comparable to 14% to 19% in previous studies 24–26 …”

Section: Discussionsupporting

confidence: 87%

“…The rate of postoperative organ/space SSI in our study was 10% and 9% in intravenous and oral groups, respectively, which is comparable to 7% to 12% observed in the recent literature. 4,7,23 The overall rate of complications was 15% in both study groups, which is comparable to 14% to 19% in previous studies. [24][25][26] Patients in the oral group had a longer time from symptom onset to surgical treatment in our trial.…”

Section: Discussionsupporting

confidence: 83%

“…A recent prospective randomized study suggested, however, a 24-hour postoperative antibacterial treatment to be noninferior in complicated appendicitis with no increased risk of infectious complications compared with extended antibiotic therapy 4 . Studies comparing different durations of postoperative antibacterial therapy have used exclusively intravenous administration of antibiotics 4–8 . However, there seems to be no consensus as to the optimal route of postappendectomy antibiotics 9 .…”

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confidence: 99%

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Short Postoperative Intravenous Versus Oral Antibacterial Therapy in Complicated Acute Appendicitis – A Pilot Non-Inferiority Randomized Trial

Lipping,

Saar,

Reinsoo

et al. 2023

Annals of Surgery

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Objective: The purpose of this study is to investigate noninferiority of postoperative oral administration of antibiotics in complicated appendicitis. Background: Recent investigations have used exclusively intravenous administration of antibiotics when comparing outcomes of postoperative antibacterial therapy in complicated appendicitis. We hypothesized that oral antibacterial treatment results in noninferior outcomes in terms of postoperative infectious complications as intravenous treatment. Methods: In this pilot, open-label, prospective randomized trial, all consecutive adult patients with complicated appendicitis including gangrenous appendicitis, perforated appendicitis, and appendicitis with periappendicular abscess between November 2020 and January 2023 were randomly allocated to 24-hour intravenous administration of antibiotics versus 24-hour oral administration of antibiotics after appendectomy. Primary outcomes included 30-day postoperative complications per Comprehensive Complication Index (CCI). Secondary outcome was hospital length of stay (HLOS). Follow-up analysis at 30 days was conducted per intention to treat and per protocol. The study was registered at ClinicalTrials.gov (NCT04947748). Results: A total of 104 patients were enrolled with 51 and 53 cases allocated to the 24-hour intravenous and the 24-hour oral treatment group, respectively. Demographic profile and disease severity score for acute appendicitis (DSS) were similar between the study groups. There were no significant differences between the study groups in terms of 30-day postoperative complications. Median CCI did not differ between the study groups. HLOS was similar in both groups. Conclusions: In the current pilot randomized controlled trial, the 24-hour oral antibiotic administration resulted in noninferior outcomes when compared to 24-hour intravenous administration of antibiotics after laparoscopic appendectomy in complicated appendicitis.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 83%

mentioning

confidence: 99%

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Short Postoperative Intravenous Versus Oral Antibacterial Therapy in Complicated Acute Appendicitis – A Pilot Non-Inferiority Randomized Trial

Lipping,

Saar,

Reinsoo

et al. 2023

Annals of Surgery

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“…Details of the trial design and methods were published. 21,24 This manuscript was prepared in accordance with the "Consolidated Standards of Reporting Trials" checklist for noninferiority randomized clinical trials and the Consolidated Health Economic Evaluation Reporting Standards checklist for economic evaluations of health interventions. 25,26 Patients Patients aged ≥ 8 years were enrolled in the study if they underwent an appendectomy for complex appendicitis and gave informed consent.…”

Section: Methods Trial Design and Oversightmentioning

confidence: 99%

“…[16][17][18][19] The antibiotics after an aPPendectomy In Complex (APPIC) appendicitis trial confirmed what previous studies 11,12,[18][19][20] suggested: 2 days of intravenous (iv) antibiotics was comparably effective and safe compared with 5 days. 21 Whereas safety and efficacy are key components in determining treatment strategy, costs, and cost-effectiveness should also be considered. Health care costs have risen over the past decades in both developed and developing countries.…”

mentioning

confidence: 99%

2 days versus 5 days of Postoperative Antibiotics for Complex Appendicitis

de Wijkerslooth,

Boerma,

van Rossem

et al. 2023

Annals of Surgery

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Objective: To compare costs for 2 days versus 5 days of postoperative antibiotics within the Antibiotics following aPPendectomy In Complex appendicitis (APPIC) trial. Summary Background Data: Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stay without compromising patient safety. Its potential effect on societal costs remains underexplored. Methods: This was a pragmatic, open-label, multicenter clinical trial powered for non-inferiority. Patients with complex appendicitis (age ≥ 8 y) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. Final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, main outcome measures were overall societal costs (comprising direct healthcare costs and costs related to productivity loss) and cost-effectiveness. Direct healthcare costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity-Cost-Questionnaire at four weeks after surgery. Cost estimates were based on prices for the year 2019. Results: In total, 1005 patients were evaluated in the Intention-to-Treat analysis: 502 patients allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was – € 625 (95% confidence interval – € 958 to – € 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to two days was cost-effective, with estimated cost savings of € 31,117 per additional infectious complication. Conclusions: 2 days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced healthcare setting. Trial Registration: Trialregister.nl number NL5946.

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Systemic glucocorticoid exposure and postoperative infection risk in 143,782 appendectomy patients—a Danish longitudinal nationwide study

Orgun,

Nordestgaard,

Poulsen

et al. 2024

Langenbecks Arch Surg

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Background Glucocorticoids are conventionally associated with increased postoperative infection risk. It is necessary to clarify if preoperative glucocorticoid exposure is associated with postoperative infection in appendectomy patients and if the association is different for open and laparoscopic appendectomies. Methods A Danish nationwide study of appendectomy patients between 1996 and 2018. Exposures were defined as high (≥ 5 mg) versus no/low (< 5 mg) glucocorticoid exposure in milligram prednisone-equivalents/day preoperatively. The main outcome was any postoperative infection. Then, 90-day cumulative incidences (absolute risk) and adjusted hazard ratios (relative risk) of the outcome were calculated for high versus no/low glucocorticoid exposure within all appendectomies and within open and laparoscopic subgroups. Propensity-score matching was used for sensitivity analysis. Results Of 143,782 patients, median age was 29 years, 74,543 were female, and 7654 experienced at least one infection during the 90-day follow-up. The 90-day cumulative incidence for postoperative infection was 5.3% within the no/low glucocorticoid exposure group and 10.0% within the high glucocorticoid exposure group. Compared to no/low glucocorticoid exposure, adjusted hazard ratios for 90-day postoperative infection with high glucocorticoid exposure were 1.25 [95% CI 1.02–1.52; p = 0.03] for all appendectomies, 1.59 [1.16–2.18; p = 0.004] for laparoscopic appendectomies, and 1.09 [0.85–1.40; p = 0.52] for open appendectomies (pinteraction < 0.001). The results were robust to sensitivity analyses. Conclusion Preoperative high (≥ 5 mg/day) glucocorticoid exposure was associated with increased absolute risk of postoperative infections in open and laparoscopic appendectomies. The relative risk increase was significant for laparoscopic but not open appendectomies, possibly due to lower absolute risk with no/low glucocorticoid exposure in the laparoscopic subgroup.

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2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial

Cited by 23 publications

References 45 publications

Short Postoperative Intravenous Versus Oral Antibacterial Therapy in Complicated Acute Appendicitis – A Pilot Non-Inferiority Randomized Trial

Short Postoperative Intravenous Versus Oral Antibacterial Therapy in Complicated Acute Appendicitis – A Pilot Non-Inferiority Randomized Trial

2 days versus 5 days of Postoperative Antibiotics for Complex Appendicitis

Systemic glucocorticoid exposure and postoperative infection risk in 143,782 appendectomy patients—a Danish longitudinal nationwide study

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