Abstract

To introduce a novel endo-luminal balloon-assisted drainage (EBAD) and compare postoperative complication rates between EBAD and diverting stoma (DS) groups. The single center prospective non-random cohort study included a total of 163 patients in convenience patients with rectal cancer between January 2019 and January 2021. Out of 163 patients, 83 underwent DS and 80 EBAD. Primary endpoints were postoperative complication rate. The total number of complications was 28 in the DS group vs. 22 in the EBAD group (P = 0.388). 18 patients (21.7%) in the DS group and 14 patients (17.5%) in the EBAD group developed postoperative complication (P = 0.501). There were no differences identified for anastomotic leak rates between the two groups (P = 0.677). The rate of the pelvic abscess was lower in the EBAD group (1/80, 1.3%) than in the DS group (4/83, 4.8%) but with no statistical significance (P = 0.386). Compared with the DS group, the median operative time was shorter in the EBAD group (225 vs. 173.5min, P < 0.001). Regarding incomplete small bowel obstruction, a higher prevalence was observed in the DS group compared to the EBAD group (7.2% vs 2.5%, P = 0.301). 7 patients (11.3%) in the DS group developed a para-stomal hernia, while no patient suffered a catheter-related complication. The median postoperative hospital stay was shorter in the DS groups than in the EBAD group (7 vs 8days, P = 0.009). The median residence time of endo-luminal balloon-assisted drainage was 5.41days. The median average and total volume of drainage were 51.57ml/day and 255ml, respectively. EBAD is feasible and safe with similar postoperative complications when compared with a DS. EBAD may replace DS after rectum resection.

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