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. 2021 Aug;23(8):2173-2181.
doi: 10.1111/codi.15681. Epub 2021 May 12.

Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2)

Gianluca Pellino  1 , Alejandro Solís-Peña  1 , Miquel Kraft  1 , Bernat Miguel Huguet  1 , Eloy Espín-Basany  1
Affiliations

Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2)

Gianluca Pellino et al. Colorectal Dis. 2021 Aug.

Abstract

Aim: Surgical site infections (SSIs) are common after colonic surgery. SSIs can cause relevant morbidity and increase costs of care. Preoperative oral antibiotics can reduce the incidence of SSIs after resection of the colon, but the role of mechanical bowel preparation (MBP) is debated. This study aims to assess the impact of a combined regimen of oral antibiotics and MBP on SSIs after colonic surgery.

Methods: An international, multicentre, pragmatic, adaptive, parallel-group, randomized controlled trial will be conducted across Europe. Adult patients scheduled to undergo elective colonic resection will be assessed for inclusion. Patients will be randomized into one of two treatment arms: (1) preoperative oral antibiotics without MBP (control); (2) preoperative oral antibiotics with MBP (experimental). All patients will receive intravenous antibiotics at anaesthetic induction. The primary aim will be 30-day SSI, assessed by a blinded nurse. Additional end-points include safety, morbidity and mortality, satisfaction with the preparation, time to return of bowel function, time to complete recovery and time to discharge, long-term results. Analyses will be performed with a modified intention-to-treat approach. Interim analyses are planned.

Discussion: This will be the first randomized clinical trial to assess the efficacy and safety of preoperative oral antibiotics plus MBP versus preoperative oral antibiotics only, before colonic surgery. The knowledge obtained could help to establish the ideal preparation for patients scheduled to undergo resection of the colon. Full protocol NCT04161599.

Keywords: colon resection; colorectal surgery; complications; mechanical bowel preparation; oral antibiotics; surgical site infection.

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References

REFERENCES

    1. Song F, Glenny AM. Antimicrobial prophylaxis in colorectal surgery: a systematic review of randomized controlled trials. Br J Surg. 1998;85:1232-41.
    1. Lewis RT. Oral versus systemic antibiotic prophylaxis in elective colon surgery: a randomized study and metaanalysis send a message from the 1990s. J Can Chir. 2002;45:173-80.
    1. Pujol M, Limón E, López-Contreras J, Sallés M, Bella F, Gudiol F, et al. Surveillance of surgical site infections in elective colorectal surgery. Results of the VINCat Program (2007-2010). Enferm Infecc Microbiol Clin. 2012;30:20-5.
    1. de la Portilla F, Builes S, García-Novoa A, Espín E, Kreisler E, Enríquez-Navascues JM, et al. Analysis of quality indicators for colorectal cancer surgery in units accredited by the Spanish Association of Coloproctology. Análisis de los indicadores de calidad en la cirugía de cáncer colorrectal de unidades acreditadas por la Asociación Española de Coloproctología. Cir Esp. 2018;96:226-33. https://doi.org/10.1016/j.ciresp.2018.02.008
    1. Badia JM, Casey AL, Rubio-Pérez I, Arroyo-García N, Espin E, Biondo S, et al. Awareness of practice and comparison with best evidence in surgical site infection prevention in colorectal surgery. Surg Infect. 2020;21:218-26. https://doi.org/10.1089/sur.2019.203

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