187 Impact of anastomotic leakage after colorectal cancer surgery on quality of life: A systematic review Risk of bias in studies The relevant categories from the ROBINS-I tool were used to assess the risk of bias (Figure 1B). We reported a serious risk of bias in ten studies, primarily attributed to the non-randomized design of these studies 19-21, 23-28 and a moderate risk of bias in the other 4 studies 22, 29-31. AL characteristics All details on AL and specific characteristics reported by each study are summarized in Supplementary S3. The reported definitions and diagnostic modalities for AL varied widely among the studies reviewed. Four studies (33%) did not report any specific definition for AL 19, 26, 27, 32. Furthermore, none of the studies applied the same definition for AL. The severity of AL was assessed using various classifications across the included studies. Four studies applied the International Study Group of Rectal Cancer (ISREC) classification 22, 25, 27, 31, while two studies utilized the Clavien-Dindo classification 19, 24. Four studies divided AL cases into symptomatic and asymptomatic, or clinical and subclinical manifestation 20, 21, 23, 26. The other studies did not provide a specific classification or grading of severity of AL. The timeframe in which AL was suspected or diagnosed was reported in four articles, with the latest reporting time being six months after surgery 20, 22, 23, 31. One study reported biochemical characteristics that might indicate surgical complications 20. Eight studies (67%) used CT-scan with or without contrast to confirm the diagnosis of AL 20, 21, 23, 24, 26, 29-31. Four studies reported performing radiological assessment, and subsequent AL assessment, only when clinical symptoms occurred 22, 24, 29, 31. Three other studies additionally performed routine scanning for AL before ileostomy closure (range 6 weeks – 3 months after surgery) 20, 23, 26. The type of re-interventions was specified in ten studies 19-27, 31 and ranged from antibiotic treatment to reoperation (laparotomy) with takedown of anastomosis and end-colostomy construction. Questionnaires A total of ten validated QoL questionnaires were administered at different time points within the studies. Four validated instruments were administered across the majority of studies (Supplementary S4): The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) -C30 (Core) and -CR29 (CRC specific), the Short-Form 36 questionnaire (SF-36) encompassing both a physical component (PCS) and a mental component score (MCS), and the Fecal Incontinence QoL (FIQL) questionnaire. Six additional questionnaires were used in only one study (Supplementary S5). These included the Cleveland Global QoL (CGQL), the EORTC IN-PATSAT32 questionnaire for assessing cancer care satisfaction, the Gastrointestinal Quality of Life Index (GIQLI) addressing digestive disorders with both physical and emotional components , the EuroQoL visual analogue scale (EQ-VAS) for patient self-rated health, the Short-Form-12 (SF-12) evaluating health impact on daily life, and the Rotterdam Symptoms Check List (RSCL) questionnaire, which generally evaluates HRQoL. 9
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