Karin Ribi1,2, Walter R Marti3, Jürg Bernhard4,5, Felix Grieder6, Michael Graf7, Beat Gloor5, Gaudenz Curti3, Markus Zuber8, Nicolas Demartines9, Christiane Andrieu10, Martin Bigler10, Stefanie Hayoz10, Heinz Wehrli11, Christoph Kettelhack12, Bruno Lerf13, Fabrizio Fasolini14, Christian Hamel15. 1. International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland. karin.ribi@ibcsg.org. 2. SAKK Coordinating Center, Bern, Switzerland. karin.ribi@ibcsg.org. 3. Kantonsspital Aarau now at chirurgieaarau, Aarau, Switzerland. 4. International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland. 5. Bern University Hospital, Inselspital, Bern, Switzerland. 6. Kantonsspital Winterthur, Winterthur, Switzerland. 7. Luzerner Kantonsspital now at Spital Muensterlingen, Muensterlingen, Switzerland. 8. Kantonsspital Solothurn, Solothurn, Switzerland. 9. Centre hospitalier universitaire vaudoise, Lausanne, Switzerland. 10. SAKK Coordinating Center, Bern, Switzerland. 11. Zürich Hirslandenklinik, Zurich, Switzerland. 12. Universitätsspital Basel, Basel, Switzerland. 13. Kantonsspital Zug, Baar, Switzerland. 14. Ospedale regionale di Mendrisio Beata Vergine, Mendrisio, Switzerland. 15. Kreiskliniken Lörrach, Lörrach, Germany.
Abstract
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 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 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.
RCT Entities:
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 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 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.