179 Impact of anastomotic leakage after colorectal cancer surgery on quality of life: A systematic review Data extraction and synthesis of results Two independent researchers (AG and DH) performed a qualitative analysis and extracted data from the main text, tables and figures using a predefined and standardized data extraction table. Extracted data included first author, year of publication, country, study design, study period, inclusion and exclusion criteria, aim of the study, number of patients, general patient characteristics, indication for surgery, surgical procedures performed, the applied (validated) QoL questionnaires, time of assessment, and secondary outcomes. Furthermore, definitions, timeframe and criteria for diagnosis of AL were collected. Data acquired via the outlined search strategy were summarized in tables. Findings were described in a narrative approach, i.e., primarily words and text were used to summarize and explain the findings. Because of the heterogeneity among included studies in terms of definition of AL and questionnaires used to assess QoL, pooling in a meta-analysis was impossible. Assessment of risk of bias in individual studies To ascertain the validity of the included studies, the risk of bias of each study was assessed by two reviewers (AG and DH) with a revised ROBINS-I 18 tool to assess risk of bias in nonrandomized studies. All types of bias were evaluated for every study and judged ‘low risk’, ‘moderate risk’ or ‘high risk’. Possible confounding domains were a priori defined as active smoking, malnutrition, male gender, Body Mass Index (BMI), comorbidities or higher American Society of Anesthesiologists (ASA) classification, emergency surgery and longer operative time. RESULTS Study selection The electronic literature search generated 1323 articles, and 980 unique articles after removing duplicates. Of these, 865 were excluded after title and abstract screening. Fulltext screening of the resulting 115 articles was performed and another 104 were excluded. Cross-reference checking generated one additional article, and one additional publication was identified after repeating the search before submission. Ultimately, 13 articles were included in the analysis (Figure 1A). Study and patient characteristics All 13 included articles were cohort or case matched studies and comprised 4596 individual patients, with study sample size ranging from 32 to 1207 patients (Table 1). Four studies reported on colorectal resections 19-22, all other studies focused on rectal resections. All studies included patients diagnosed with CRC, with only two studies also including patients with benign indications for colorectal resections (e.g., diverticulitis or inflammatory bowel disease). As benign indications were presented separately, the outcome of these patients were excluded in this review 20, 21. The final population consisted of 4618 patients, of which 9
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