29 Quality of reporting on anastomotic leaks in colorectal trials: A systematic review Study Risk of Bias Assessment To assess the methodological quality of the included studies, the risk of bias was independently assessed by 2 reviewers (DH, OM). RCTs were assessed using the RoB2 tool, while (systematic) reviews and meta-analyses were assessed using the ROBIS tool 17, 18. All types of bias were evaluated and judged as low-, moderate-, or high risk resulting in an overall bias judgement. The bias was visualized using the Risk-of-bias visualization (Robvis) tool 19. RESULTS Study Selection The electronic search yielded 1,792 studies after removing duplicates and publications before 2000. After screening abstracts, 644 potentially eligible studies remained, based on the predefined inclusion and exclusion criteria. Full-text assessment from 134 studies was not possible (i.e., no full-texts available, or retracted articles), whereafter 511 articles remained eligible. Reference checking resulted in 13 additional studies, resulting in 524 studies for full-text assessment. Fifty-three studies did not meet inclusion criteria; the remaining 471 studies reported AL as a primary or secondary outcome. Of these, 376 did not report a definition of AL, which resulted in the inclusion of 95 studies. The study selection process is summarized in Figure 1. Study characteristics The 95 studies included 45 RCTs, 13 SRs, and 37 meta-analyses (MAs) published between 2000 and 2022. The main characteristics of the included studies are summarized in Table 1. 2
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