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Objective: To compare, in a phase 3, prospective, randomized, multi-center clinical trial functional outcome of reconstruction procedures following total mesorectal excision (TME). Summary Background Data: Intestinal continuity reconstruction following TME is accompanied by postoperative defecation dysfunctions known as ''anterior resection syndrome.'' Commonly used reconstruction techniques are straight colorectal anastomosis (SCA), colon J-pouch (CJP), and side-toend anastomosis (SEA). Comparison of their functional outcomes in prospective, randomized, multi-center studies, including long-term assessments, is lacking. Methods: Patients requiring TME for histologically proven rectal tumor, with or without neoadjuvant treatment, age ! 18 years, normal sphincter function without history of incontinence, any pretreatment staging or adenoma, expected R0-resection, were randomized for standardized SCA, CJP, or SEA procedures. Primary endpoint was comparison of composite evacuation scores 12 months after TME. Comparison of composite evacuation and incontinence scores at 6, 18 and 24 months after surgery, morbidity, and overall survival represented secondary endpoints. Analysis was based on ''per protocol'' (PP) population, fully complying with trial requirements, and intention-to treat (ITT) population. Results: Three hundred thirty-six patients from 15 hospitals were randomized. PP population included 257 patients (JCP ¼ 63; SEA ¼ 95; SCA ¼ 99). Composite evacuation scores of PP and ITT populations did not show statistically significant differences among the 3 groups at any time point. Similarly, composite incontinence scores for PP and ITT populations showed no statistically significant difference among the 3 trial arms at any time point. Conclusions: Within boundaries of investigated procedures, surgeons in charge may continue to perform reconstruction of intestinal continuity following TME at their technical preference.

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Background. Functional outcomes of different reconstruction techniques have an impact on patients' quality of life (QoL), but information on long-term QoL is lacking. We compared QoL among three reconstruction techniques after total mesorectal excision (TME). Methods. Quality of life was assessed within a randomized, multicenter trial comparing rectal surgery using sideto-end anastomosis (SEA), colon J-pouch (CJP), and straight colorectal anastomosis (SCA) by the Functional Assessment of Cancer Therapy-Colorectal scale (FACT-C) before randomization and every 6 months up to 2 years post-TME. The primary QoL endpoint was the change in the Trial Outcome Index (TOI), including the FACT-C subscales of physical and functional well-being and colorectal cancer symptoms (CSS), from baseline to month 12. Pair-wise comparisons of changes from baseline (presurgery) to each timepoint between the three arms were analyzed by Mann-Whitney tests. Results. For the QoL analysis, 257 of 336 randomized patients were in the per protocol evaluation (SEA = 95; CJP = 63; SCA = 99). Significant differences between the reconstruction techniques were found for selected QoL scales up to 12 months, all in favor of CJP. Patients with SEA or SCA reported a clinically relevant deterioration for TOI and CSS at 6 months, those with SCA for CSS also at 12 months after TME. Patients with CJP remained stable. Conclusions. Although the three reconstruction techniques differ in their effects on QoL at months 6 and 12, these differences did not persist over the whole observation period of 24 months. Patients with a colon J-pouch may benefit with respect to QoL in the short-term.Total mesorectal resection (TME) has improved survival and reduced local recurrence in patients with rectal cancer. 1 Reconstruction techniques after TME include straight colorectal anastomosis (SCA), colon J-pouch (CJP), sideto-end anastomosis (SEA), and transverse coloplasty. 2 SCA leads to the loss of the rectal reservoir, which can cause high defecation frequency, fecal urgency, and