49 Quality of reporting on anastomotic leaks in colorectal trials: A systematic review A consensus study by Helsdingen et al. (2020) already reported recommendations for a definition and category elements of AL based on experts’ opinions13 By comparing the results of our review to the recommendations formulated in this consensus, we confirm a lack of reporting the categories suggested (clinical parameters, laboratory tests, radiological findings, findings during reoperation, grading systems, timing, location of the tumor). The most common element used for AL reporting was clinical symptoms and signs associated with AL. Compared to the ISREC definitions, our results for clinical elements showed many similarities. However, several clinical elements from our search were not included in the original ISREC classification 10. The most frequently used biochemical result was leukocytosis. In contrast, while CRP was also included in the ISREC classification, its use was only mentioned in 7 studies 36, 64, 69, 71, 78, 96, 112. There is no uniformity in recommendations regarding a preferred imaging modality when suspecting an AL. The most often used modality to support the diagnosis of a leak in our analysis was by CT. However, it was often unclear whether these were CTs performed with rectal, intravenous or oral contrast. While a previous SR and MA by Kornmann et al. reported the scarce and poor quality of evidence regarding the predictive value of CT in diagnosing AL, Matsuda et al. and Lim et al. specifically used CT for confirmation when there was suspicion of AL 8, 12, 116. For now, it is unclear how much additional information rectal contrast provides over clinical assessment for low anastomoses.117 Notably, the role of endoscopic assessment in the assessment of AL is poorly investigated despite low procedural risk and rapid detection of AL 118. Besides the type of imaging modality used, the detailed findings are important too. The most frequently described finding was an abdominal or pelvic collection and/or abscess in the proximity of the anastomosis on CT scan although radiological criteria considered diagnostic of AL remain controversial 14. Upon diagnosis of AL, the type of re-intervention and findings at reintervention were underreported in the summarized evidence. It is important to report the type of re-intervention(s) as this may correlate with time to resolution of AL, return to function and long term outcomes and quality of life. Only 13% of included studies reported type of re-intervention(s) which highlights a significant gap in reporting. The lack of standardized definitions and agreement on the specific elements of an AL contributed to significant variations in the reported rates, making it challenging to identify risk factors for leaks and evaluate the effectiveness of specific therapeutic and prophylactic interventions. Most studies considered AL to involve a breach in the integrity of the intestinal wall at the site of colorectal or colonanal anastomosis, with severity ranging from incidental findings to life-threatening sepsis requiring further surgery. However, substantial variability was uncovered regarding the minimum criteria for reporting AL. Grading of the severity of AL may have major implications with respect to timing and type of required intervention, prognosis, short- and long-term outcomes. However, less than half of included studies reported grading or classification of AL. The most common grading system reported was the ISREC classification, followed by the Clavien-Dindo classification, although this is not specific to AL 119. Furthermore, our results also showed that there was some effort 2
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