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. 2023 Feb 7;2023(2):CD014909. doi: 10.1002/14651858.CD014909.pub2

Risk of bias for analysis 3.4 Anastomotic leakage.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Koskenvuo 2019 Low risk of bias Generation of randomisation sequence and concealment of allocation were adequate. There was no baseline imbalance that would suggest a problem with randomisation. Low risk of bias Both participants and those delivering the intervention were aware of intervention received. There were no deviations from intervention. Low risk of bias 95% of randomised patients were analysed in the modified intention‐to‐treat analysis. Low risk of bias The assessors were not blinded, but it is unlikely that knowledge of the intervention would have influenced the assessment, as anastomotic leakages are clearly defined clinically Low risk of bias The trial was registered with ClinicalTrials.gov (NCT02652637) and EudraCT (2015‐004559‐38). Low risk of bias Low risk of bias in all domains.