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Cited 95 time in webofscience Cited 93 time in scopus
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COLOR II - A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

Authors
Bonjer, H. J.Cuesta, M. A.Lacy, A. M.Haglind, E.Fuerst, A.Lange, J. F.Hop, W. C. J.Buunen, M.D'Hoore, A.Inglis, K.Jess, P.Bulut, O.Rosenberg, J.PeimanChristensen, M. MarkIsalnieks, I.Jaeger, C.Kreis, M.Jeekel, J.van der Harst, E.Coenen, P. P. L. O.Gerhards, M. F.Bemelman, W.Jakimowicz, J. J.van Riet, Y. E. A.Hansson, B. M. E.Rosman, C.Neijenhuis, P. A.den Outer, A. J.Targarona, E. M.Balague, C.Delgado, S.Lujan, J.Garcia Molina, F. J.Skullman, S.Kurlberg, G.Lackberg, Z.Pahlman, L.Kressner, U.Matthiessen, P.Kim, Seon-Hahn
Issue Date
May-2009
Publisher
DANISH MEDICAL ASSOC
Citation
DANISH MEDICAL BULLETIN, v.56, no.2, pp.89 - 91
Indexed
SCIE
SCOPUS
Journal Title
DANISH MEDICAL BULLETIN
Volume
56
Number
2
Start Page
89
End Page
91
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/16048
ISSN
0907-8916
Abstract
Introduction: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. Methods: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. Results: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). Conclusion: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).
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2. Clinical Science > Department of Colon and Rectal Surgery > 1. Journal Articles

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