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Prevention of anastomotic leak in rectal cancer surgery with local antibiotic decontamination: a prospective, randomized, double-blind, placebo-controlled single center trial

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Abstract

Purpose

Anastomotic leak and other infectious complications are septic complications of rectal cancer surgery caused by bacteria. Data from registry analysis show a beneficial effect of local antimicrobial administration on anastomotic leaks, but data are inconsistent in recent clinical trials. Therefore, our aim was to study the efficacy of topical antibiotic treatment on the incidence of anastomotic leaks in rectal cancer surgery.

Methods

A prospective, randomized, double-blind and placebo-controlled, single center trial was conducted. Patients received either placebo and amphotericin B or decontamination with polymyxin B, tobramycin, vancomycin, and amphotericin B four times per day starting the day before surgery until postoperative day 7. If a protective ileostomy was created, a catheter was placed transanally and the medication was administered locally to the anastomotic site. All patients received an intravenous perioperative antibiotic prophylaxis.

Results

The trial had to be stopped for ethical reasons after first interim analysis with 80 patients instead of the initially planned 280 patients. Of the 40 patients randomized to receive placebo, eight (20%) developed anastomotic leak compared to only 2 (5%) in the treatment group of 40 patients (decontamination) with significant difference in the χ2 test (p = 0.0425). Twenty percent of the placebo group and 12.5% in the treatment group developed infectious complications not associated with anastomotic leak (p = 0.5312). One patient (2.5%) in the placebo group died (p = 0.3141).

Conclusion

Local decontamination with polymyxin, tobramycin, vancomycin, and amphotericin B is safe and effective in the prevention of anastomotic leak in rectal cancer surgery.

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Acknowledgments

We thank Prof. John C. Alverdy, MD, for his editorial assistance in the preparation of this manuscript.

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Authors and Affiliations

  1. Department of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany

    H. M. Schardey, Ulrich Wirth, T. Strauss, M. S. Kasparek, D. Schneider & K. W. Jauch

  2. Department of General, Visceral and Vascular Surgery, Agatharied Hospital, Norbert-Kerkel-Platz, 83734, Hausham, Germany

    H. M. Schardey

  3. AGAPLESION Diakonieklinikum Rotenburg, 27356, Rotenburg, Germany

    T. Strauss

  4. Department of Visceral Surgery, Josephinum, Schönfeldstraße 16, 80539, Munich, Germany

    M. S. Kasparek

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  1. H. M. Schardey
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  2. Ulrich Wirth
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  4. M. S. Kasparek
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Contributions

The study was planned, designed, and financed by Schardey HM; carried out by Strauss T, Schneider D. Data collection and analysis were performed by Kasparek MS and Wirth U. The first draft of the manuscript was written by Schardey HM and Kasparek MS, senior author Jauch KW. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Ulrich Wirth.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board (Ethikkommission der Medizinischen Fakultät, LMU München) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Schardey, H.M., Wirth, U., Strauss, T. et al. Prevention of anastomotic leak in rectal cancer surgery with local antibiotic decontamination: a prospective, randomized, double-blind, placebo-controlled single center trial. Int J Colorectal Dis 35, 847–857 (2020). https://doi.org/10.1007/s00384-020-03544-8

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