Laparoscopic-assisted versus open total mesorectal excision with anal sphincter preservation for mid and low rectal cancer: a prospective, randomized trial
- 925 Downloads
This single-center, prospective, randomized trial was designed to compare the short-term clinical outcome between laparoscopic-assisted versus open total mesorectal excision (TME) with anal sphincter preservation (ASP) in patients with mid and low rectal cancer. Long-term morbidity and survival data also were recorded and compared between the two groups.
Between August 2001 and August 2007, 80 patients with mid and low rectal cancer were randomized to receive either laparoscopic-assisted (40 patients) or open (40 patients) TME with ASP. The median follow-up time for all patients was 75.7 (range 16.9–115.7) months for the laparoscopic-assisted group and 76.1 (range 4.7–126.6) months for the open group. The primary endpoint of the study was short-term clinical outcome. Secondary endpoints included long-term morbidity rate and survival. Data were analyzed by intention-to-treat principle.
The demographic data of the two groups were comparable. Postoperative recovery was better after laparoscopic surgery, with less analgesic requirement (P < 0.001), earlier mobilization (P = 0.001), lower short-term morbidity rate (P = 0.043), and a trend towards shorter hospital stay (P = 0.071). The cumulative long-term morbidity rate also was lower in the laparoscopic-assisted group (P = 0.019). The oncologic clearance in terms of macroscopic quality of the TME specimen, circumferential resection margin involvement, and number of lymph nodes removed was similar between both groups. After curative resection, the probabilities of survival at 5 years of the laparoscopic-assisted and open groups were 85.9 and 91.3 %, respectively (P = 0.912). The respective probabilities of being disease-free were 83.3 and 74.5 % (P = 0.114).
Laparoscopic-assisted TME with ASP improves postoperative recovery, reduces short-term and long-term morbidity rates, and seemingly does not jeopardize survival compared with open surgery for mid and low rectal cancer (http://ClinicalTrials.gov Identifier: NCT00485316).
KeywordsTotal mesorectal excision Laparoscopic surgery Anal sphincter preservation Rectal cancer Randomized trial
This study is not supported by any grant.
Simon S. M. Ng, Janet F. Y. Lee, Raymond Y. C. Yiu, Jimmy C. M. Li, Sophie S. F. Hon, Tony W. C. Mak, Dennis K. Y. Ngo, Wing Wa Leung, and Ka Lau Leung have no conflict of interest or financial ties to disclose.
- 2.Fleshman J, Sargent DJ, Green E, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Nelson H, Clinical Outcomes of Surgical Therapy Study Group (2007) Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg 246:655–662PubMedCrossRefGoogle Scholar
- 3.Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy AM, COlon cancer Laparoscopic or Open Resection Study Group (COLOR) (2005) Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 6:477–484PubMedCrossRefGoogle Scholar
- 4.Colon Cancer Laparoscopic or Open Resection Study Group, Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ (2009) Survival after laparoscopic versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol 10:44–52PubMedCrossRefGoogle Scholar
- 5.Hewett PJ, Allardyce RA, Bagshaw PF, Frampton CM, Frizelle FA, Rieger NA, Smith JS, Solomon MJ, Stephens JH, Stevenson AR (2008) Short-term outcomes of the Australasian randomized clinical study comparing laparoscopic and conventional open surgical treatments for colon cancer: the ALCCaS trial. Ann Surg 248:728–738PubMedCrossRefGoogle Scholar
- 6.Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM, MRC CLASICC trial group (2005) Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 365:1718–1726PubMedCrossRefGoogle Scholar
- 9.Kang SB, Park JW, Jeong SY, Nam BH, Choi HS, Kim DW, Lim SB, Lee TG, Kim DY, Kim JS, Chang HJ, Lee HS, Kim SY, Jung KH, Hong YS, Kim JH, Sohn DK, Kim DH, Oh JH (2010) Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol 11:637–645PubMedCrossRefGoogle Scholar
- 10.van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ, COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group (2013) Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol 14(3):210–218. doi: 10.1016/S1470-2045(13)70016-0 PubMedCrossRefGoogle Scholar
- 12.Tjandra JJ, Kilkenny JW, Buie WD, Hyman N, Simmang C, Anthony T, Orsay C, Church J, Otchy D, Cohen J, Place R, Denstman F, Rakinic J, Moore R, Whiteford M, Standards Practice Task Force of the American Society of Colon and Rectal Surgeons (2005) Practice parameters for the management of rectal cancer (revised). Dis Colon Rectum 48:411–423PubMedCrossRefGoogle Scholar
- 13.Society of American Gastrointestinal and Endoscopic Surgeons SAGES (2006) Guidelines for laparoscopic resection of curable colon and rectal cancer. Available at: http://www.sages.org/publication/id/32. Accessed 28 Feb 2013
- 21.Sauer R, Fietkau R, Wittekind C, Rödel C, Martus P, Hohenberger W, Tschmelitsch J, Sabitzer H, Karstens JH, Becker H, Hess C, Raab R, German Rectal Cancer Group (2003) Adjuvant vs. neoadjuvant radiochemotherapy for locally advanced rectal cancer: the German trial CAO/ARO/AIO-94. Colorectal Dis 5:406–415PubMedCrossRefGoogle Scholar
- 22.Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R, German Rectal Cancer Study Group (2004) Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351:1731–1740PubMedCrossRefGoogle Scholar
- 31.Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rödel C (2012) Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol 30:1926–1933PubMedCrossRefGoogle Scholar
- 32.Younis J, Salerno G, Fanto D, Hadjipavlou M, Chellar D, Trickett JP (2012) Focused preoperative patient stoma education, prior to ileostomy formation after anterior resection, contributes to reduction in delayed discharge within the enhanced recovery programme. Int J Colorectal Dis 27:43–47PubMedCrossRefGoogle Scholar