43 Quality of reporting on anastomotic leaks in colorectal trials: A systematic review Risk of bias in studies Forty-five RCTs (47%) were assessed for risk of bias (Figure 2A and 2C). The judgment was based on the categories of bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in the measurement of the outcome, and bias in the selection of the reported results. Upon evaluation, the highest risk of bias was attributed to the randomization process and deviations from intended interventions. Overall, nearly half of the studies (44%) were determined to have a high risk of bias. Fifty (53%) SRs with or without meta-analysis were assessed for risk of bias (Figure 2B and 2D) Risk assessment was based on study eligibility criteria, identification and selection of studies, data collection and study appraisal, and synthesis and findings. In general, these studies had a lower risk of bias than RCTs, with just a quarter of studies (24%) judged as having a high risk of bias. Terminology, definitions, and timeframe for AL reporting The term most frequently used to describe the complication of failure of the integrity of the anastomosis was anastomotic leakage. Other terms used less commonly included anastomotic dehiscence, insufficiency, failure, breakdown, defect, or separation. Nearly half of included studies (n = 44. Table 2 and Supplement 2) used a more extensive definition to describe AL20, 23, 24, 26, 28, 30, 33, 35, 36, 38, 39, 42, 48, 50, 55, 57, 58, 60, 62-65, 69, 70, 73, 79, 84, 85, 88-90, 94-96, 98-100, 103-105, 107, 108, 111, 112. The most commonly described definition was the ISREC definition (n = 25), which describes an AL as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neo-rectal reservoirs) leading to a communication between the intra- and extra-luminal compartments. The timeframe during which AL was diagnosed was reported in 39 studies, of which most (n = 24, 62%) reported AL only within 30 days after index surgery. Other reporting elements An overview of all reporting elements is displayed in Table 3. Clinical and biochemical elements A total of 65 studies (68%) reported clinical signs and symptoms associated with AL, either as part of the formulated definition or in the description of the method of diagnosis 20-22, 25-27, 29, 31, 32, 34, 36-46, 49-53, 58, 61-64, 68-79, 81-83, 85-87, 92-96, 98-100, 102, 104, 105, 107, 109, 111, 113, 114. The most frequently described clinical signs/symptoms were purulent or feculent discharge from a drain, peritonitis, fever, and fistula formation. Additionally, 26% (n = 25) of publications reported biochemical elements in the description of the method of AL diagnosis 25, 31, 34, 36, 40, 51, 52, 64, 69-72, 78, 79, 82, 94, 96, 100, 102, 105, 109, 112-115. The most described biochemical markers were leukocytosis and C-reactive protein (CRP). 2
RkJQdWJsaXNoZXIy MTk4NDMw