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)
- 202 Downloads
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).
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.
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.
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.
This work was partially supported by a grant from Oncosuisse (OCS 01579-08-2004) and by the Swiss State Secretariat for Education, Research and Innovation (SERI).
- 2.Brown CJ, Fenech DS, McLeod RS. Reconstructive techniques after rectal resection for rectal cancer. Cochrane Database Syst Rev. 2008;2:1–38.Google Scholar
- 8.Fazio VW, Zutshi M, Remzi FH, et al. A randomized multicenter trial to compare long-term functional outcome, quality of life, and complications of surgical procedures for low rectal cancers. Ann Surg. 2007;246:481–8; discussion 488–90.Google Scholar
- 11.Marti WR, Curti G, Wehrli H, et al. Clinical outcome after rectal replacement with side-to-end, colon-J-Pouch, or straight colorectal anastomosis following total mesorectal excision: a Swiss Prospective, Randomized, Multicenter Trial (SAKK 40/04). Ann Surg. 2018. https://doi.org/10.1097/sla.0000000000003057.
- 14.Russell MM, Ganz PA, Lopa S, et al. Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04. Ann Surg. 2015;261:144–8.CrossRefPubMedPubMedCentralGoogle Scholar
- 19.Brunner E, Domhof S, Langer F. Nonparametric analysis of longitudinal data in factorial experiments. New York: Wiley; 2002.Google Scholar
- 20.Bernhard J, Hurny C, Maibach R, et al. Quality of life as subjective experience: reframing of perception in patients with colon cancer undergoing radical resection with or without adjuvant chemotherapy. Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol. 1999;10:775–82.Google Scholar
- 23.Stephens RJ, Thompson LC, Quirke P, et al. Impact of short-course preoperative radiotherapy for rectal cancer on patients’ quality of life: data from the Medical Research Council CR07/National Cancer Institute of Canada Clinical Trials Group C016 randomized clinical trial. J Clin Oncol. 2010;28:4233–9.CrossRefPubMedGoogle Scholar