Quality of Life After Total Mesorectal Excision and Rectal Replacement: Comparing Side-to-End, Colon J-Pouch and Straight Colorectal Reconstruction in a Randomized, Phase III Trial (SAKK 40/04)

Abstract

BackgroundFunctional 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).MethodsQuality of life was assessed within a randomized, multicenter trial comparing rectal surgery using side-to-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\xa0months up to 2\xa0years 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.ResultsFor the QoL analysis, 257 of 336 randomized patients were in the per protocol evaluation (SEA\u2009=\u200995; CJP\u2009=\u200963; SCA\u2009=\u200999). Significant differences between the reconstruction techniques were found for selected QoL scales up to 12\xa0months, all in favor of CJP. Patients with SEA or SCA reported a clinically relevant deterioration for TOI and CSS at 6\xa0months, those with SCA for CSS also at 12\xa0months after TME. Patients with CJP remained stable.ConclusionsAlthough 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\xa0months. Patients with a colon J-pouch may benefit with respect to QoL in the short-term.