27 Quality of reporting on anastomotic leaks in colorectal trials: A systematic review INTRODUCTION Despite advances in preoperative risk assessment, operative techniques and strategies, and postoperative care, the incidence of anastomotic leakage (AL) after colorectal cancer (CRC) surgery has not improved over the recent decades; with an incidence of 1.5 to 23% and with mortality rates as high as 16%-29% 1-5. AL negatively impacts oncological outcomes, functional outcomes, and quality of life due to reoperation, permanent diversion, or delayed ostomy reversal 2, 3, 5. In addition, AL leads to increased hospital costs adding to the overall economic burden associated with CRC surgery 6. AL can present as small defects without air or fluid extravasation or large defects with or without localized abscess, phlegmon, and/or peritonitis 7, 8. The clinical impact of AL varies from minimal or no symptoms to substantial morbidity and mortality from abdominal and/or pelvic sepsis 9. Clinical studies where AL serves as a primary endpoint are often difficult to compare given considerable heterogeneity in the definition, severity grading, and diagnostic modalities used to assess AL. Despite efforts to create a validated consensus definition and severity grading system by the International Study Group of Rectal Cancer (ISREC) in 2010; this has not been widely adopted in clinical practice 10-12. A survey study among Dutch and Chinese colorectal surgeons highlighted ongoing lack of national and international agreement on definitions of AL 13. Hence, several definitions of AL continue to be used in studies, with most controversy surrounding the radiological criteria considered diagnostic of AL. A panel of eight senior US surgeons attempted to reach consensus on the definition of AL, specifically evaluating clinical and radiological criteria 14. Consensus could only be achieved in a few specific cases for both a radiological and clinical description, and only for specific types of interventions. The development of an internationally accepted standardized framework for defining, reporting and, grading colorectal AL is needed to facilitate earlier identification, reporting and treatment of AL in order to reduce short and long-term sequelae. A widely implemented standardized framework could serve as a template for clinical trials where the incidence of AL is used as a clinical end point. This systematic review aimed to gain insight into the different elements contributing to the general definition and reporting of AL in the literature. The findings of this study will serve as the basis of an ongoing project to develop a framework for reporting and grading AL after CRC surgery (Consensus Reporting of colorectal Anastomotic Leaks; CoReAL). METHODS This systematic review was reported according to the guidelines of the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) 15. The protocol has been prospectively registered at PROSPERO ID 454660. 2
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