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Early complication detection after colorectal surgery (CONDOR): study protocol for a prospective clinical diagnostic study

  • Clinical Study Protocol
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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

Anastomotic leakage is one of the most feared complications following colorectal surgery with a high morbidity and mortality rate. Multiple risk factors have been identified, but leakage still occurs. Early detection is crucial in order to reduce morbidity and mortality. The aim of this study is to create a decision algorithm for early detection of anastomotic leakage.

Methods

All patients who undergo elective colorectal surgery for benign or malignant disease are enrolled in this multicenter study. The primary endpoint is the accuracy of the prediction of anastomotic leakage. The main study parameter is the occurrence of postoperative anastomotic leakage. Secondary study parameters are clinical (vital) parameters, additional laboratory or radiology examination, other complications, mortality, re-intervention, duration of hospital and intensive care stay, emergency room visits, readmission to the hospital and total costs. Daily physical examination and each step in clinical decision making will be evaluated prospectively in a standardized manner. The focus of the analysis will be on the added value of diagnostic tools, such as laboratory results and imaging studies, over physical examination by using logistic regression and decision tree analysis.

Conclusion

This study aims to develop an optimal diagnostic algorithm that can act as a guideline for surgeons or surgical residents to early identify patients with anastomotic leakage after colorectal surgery.

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Acknowledgments

Authors’ contribution

VK drafted the manuscript. VK, BvR, AvG, SvD, MB and DB co-authored the writing of the manuscript. VK, BvR, AvG, MB and DB participated in the design of the study. VK and SvD participated in the design of the statistical analysis. All authors edited the manuscript and read and approved the final protocol and manuscript.

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Authors and Affiliations

  1. Department of Surgery, St. Antonius Hospital, 3435 CM, Nieuwegein, The Netherlands

    Verena Kornmann, Bert van Ramshorst & Djamila Boerma

  2. Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands

    Susan van Dieren & Marja Boermeester

  3. Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands

    Nanette van Geloven

Authors
  1. Verena Kornmann
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  2. Bert van Ramshorst
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  3. Susan van Dieren
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  4. Nanette van Geloven
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  5. Marja Boermeester
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  6. Djamila Boerma
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Corresponding author

Correspondence to Verena Kornmann.

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Conflict of interest

The authors declare that they have no competing interests.

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The authors declare that there is no funding.

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Kornmann, V., van Ramshorst, B., van Dieren, S. et al. Early complication detection after colorectal surgery (CONDOR): study protocol for a prospective clinical diagnostic study. Int J Colorectal Dis 31, 459–464 (2016). https://doi.org/10.1007/s00384-015-2468-3

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  • DOI: https://doi.org/10.1007/s00384-015-2468-3

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