Background: One of the most severe complications of low anterior rectal resection is anastomotic leakage (AL). The creation of a loop ileostomy (LI) reduces the prevalence of AL requiring surgical intervention. However, up to one-third of temporary stomas may never be closed. The first aim of the study was to perform a retrospective assessment of the impact of LI on the risk of permanent stoma (PS) and symptomatic AL. The second aim of the study was to assess preoperative PS risk factors in patients with LI. Methods: A total of 286 consecutive patients who underwent low anterior rectal resection were subjected to retrospective analysis. In 101 (35.3%) patients, diverting LI was performed due to low anastomosis, while in the remaining 185 (64.7%) patients, no ileostomy was performed. LIs were reversed after adjuvant treatment. Analyses of the effect of LI on symptomatic AL and PS were performed. Among the potential risk factors for PS, clinical factors and the values of selected peripheral blood parameters were analysed. Results: PS occurred in 37.6% and 21.1% of the patients with LI and without LI, respectively (p < 0.01). Symptomatic ALs were significantly more common in patients without LI. In this group, symptomatic ALs occurred in 23.8% of patients, while in the LI group, they occurred in 5% of patients (p < 0.001). In the LI group, the only significant risk factor for PS in the multivariate analysis was preoperative plasma fibrinogen concentration (OR = 1.007, 97.5% CI 1.002-1.013, p = 0.013). Conclusions: Although protective LI may reduce the incidence of symptomatic AL, it can be related to a higher risk of PS in this group of patients. The preoperative plasma fibrinogen concentration can be a risk factor for PS in LI patients and may be a useful variable in decision-making models.
506 Background: The aim of the study is to verify hypothesis that accelerated hyperfractionated preoperative radiotherapy for rectal cancer (HART) may provide a favorable long-term tolerance compared to treatment given in higher fraction (fx) doses (HYPO). This report focuses on early outcomes of the study. Comparison of late tissue reactions, evaluation of QLQ and long-term outcome in both trial arms is the ultimate goal. Methods: Between 2005 and 2011, 238 patients (pts) with cT3-4 resectable adenocarcinoma of the rectum were enrolled, which represents app. 70% of an overall trial size. The pts were randomly assigned to HART (n=122) or HYPO (n=116). The pelvis was irradiated 2x/day to the total dose of 42 Gy in 1.5 Gy/fx over 18 days (HART). Patients in HYPO received 39 Gy in 3.0 Gy/fx over 17 days. Postoperative chemotherapy (PCT) was given to ypN+ pts. Results: The actuarial perioperative complication rate at 1 year after treatment was 24.4% vs. 33.4% for HART and HYPO resp. (RR=0.69, p=0.13). The crude rate of pts with any surgical complication during the follow-up (median of 3.1 year) was 32/122 (26.2%) vs. 36/116 (31.0%) for HART and HYPO resp. (p= 0.41). If the values were expr. In terms of number of events (some pts had more than one complication) the rates were 55 events per 122 pts (HART) vs. 63 events per 116 pts (HYPO). Anastomotic leakage appeared in 11/122 HART pts (9.0%) vs. 16/116 in HYPO (13.8%). Anterior resection was performed in 48.8 % vs. 44.1% for HART and HYPO resp. PCT was given to 46.1% of the pts in HART and 45.4% in HYPO. There were no significant differences in 3-year loco-regional control (RR=1.08, p=0.44) and overall survival (RR=0.97, p=0.72) between HART and HYPO, with actuarial rates (for both arms) of 85% and 73% resp. Neither the rate of complicatons, nor type of surgery were influenced by duration of the interval RT-surgery (median 11, Std±18 days) Conclusions: The perioperative complication rate observed had the propensity to favor HART over HYPO, but the differences did not reach the level of statistical significance. Longer follow-up and the analysis encompassing all of the pts enrolled is required to fully address the study endpoints.
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