Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

H. J. Bonjer; A. M. Lacy; E. Haglind; J. F. Lange; A. D'Hoore; G. Kurlberg; W. C.J. Hop; E. Kuhry; M. Buunen; J. Rosenberg; M. A. Cuesta; A. Fürst; P. Jess; O. Bulut; P. Poornoroozy; K. Juul Jensen; M. Mark Christensen; E. Lundhus; H. Evesen; D. Birch; I. Iesainieks; C. Jäger; M. Kreis; Y. E.A. van Riet; E. van der Harst; M. F. Gerhards; W. A. Bernelman; B. M.E. Hansson; P. A. Neijenhuis; H. A. Prins; C. Balague; E. M. Targarona; J. A. Luján Mompeán; J. D.Franco Osorio; F. J.Garcia Molina; S. Skullman; Z. Läckberg; U. Kressner; P. Matthiessen; S. H. Kun; A. Alfredo Poza; K. Inglis; J. Jeekel; P. P.L.O. Coenen; J. J. Jakimowicz; C. Rosman; A. J. den Outer; S. Delgado; L. Påhlman; S. H. Kim

Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

H. J. Bonjer, A. M. Lacy, E. Haglind, J. F. Lange, A. D'Hoore, G. Kurlberg, W. C.J. Hop, E. Kuhry, M. Buunen, J. Rosenberg, M. A. Cuesta, A. Fürst, P. Jess, O. Bulut, P. Poornoroozy, K. Juul Jensen, M. Mark Christensen, E. Lundhus, H. Evesen, D. BirchI. Iesainieks, C. Jäger, M. Kreis, Y. E.A. van Riet, E. van der Harst, M. F. Gerhards, W. A. Bernelman, B. M.E. Hansson, P. A. Neijenhuis, H. A. Prins, C. Balague, E. M. Targarona, J. A. Luján Mompeán, J. D.Franco Osorio, F. J.Garcia Molina, S. Skullman, Z. Läckberg, U. Kressner, P. Matthiessen, S. H. Kun, A. Alfredo Poza, K. Inglis, J. Jeekel, P. P.L.O. Coenen, J. J. Jakimowicz, C. Rosman, A. J. den Outer, S. Delgado, L. Påhlman, S. H. Kim

Research output: Contribution to journal › Article in an indexed scientific journal › peer-review

101 Scopus citations

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).

Original language	English
Pages (from-to)	89-91
Number of pages	3
Journal	Danish Medical Bulletin
Volume	56
Issue number	2
State	Published - May 2009
Externally published	Yes

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Bonjer, H. J., Lacy, A. M., Haglind, E., Lange, J. F., D'Hoore, A., Kurlberg, G., Hop, W. C. J., Kuhry, E., Buunen, M., Rosenberg, J., Cuesta, M. A., Fürst, A., Jess, P., Bulut, O., Poornoroozy, P., Juul Jensen, K., Christensen, M. M., Lundhus, E., Evesen, H., ... Kim, S. H. (2009). Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Danish Medical Bulletin, 56(2), 89-91.

@article{1c26389d05dd4dc3a796ee2bab04fcc7,

title = "Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer",

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).",

author = "Bonjer, {H. J.} and Lacy, {A. M.} and E. Haglind and Lange, {J. F.} and A. D'Hoore and G. Kurlberg and Hop, {W. C.J.} and E. Kuhry and M. Buunen and J. Rosenberg and Cuesta, {M. A.} and A. F{\"u}rst and P. Jess and O. Bulut and P. Poornoroozy and {Juul Jensen}, K. and Christensen, {M. Mark} and E. Lundhus and H. Evesen and D. Birch and I. Iesainieks and C. J{\"a}ger and M. Kreis and {van Riet}, {Y. E.A.} and {van der Harst}, E. and Gerhards, {M. F.} and Bernelman, {W. A.} and Hansson, {B. M.E.} and Neijenhuis, {P. A.} and Prins, {H. A.} and C. Balague and Targarona, {E. M.} and {Luj{\'a}n Mompe{\'a}n}, {J. A.} and Osorio, {J. D.Franco} and Molina, {F. J.Garcia} and S. Skullman and Z. L{\"a}ckberg and U. Kressner and P. Matthiessen and Kun, {S. H.} and Poza, {A. Alfredo} and K. Inglis and J. Jeekel and Coenen, {P. P.L.O.} and Jakimowicz, {J. J.} and C. Rosman and {den Outer}, {A. J.} and S. Delgado and L. P{\aa}hlman and Kim, {S. H.}",

year = "2009",

month = may,

language = "Ingl{\'e}s",

volume = "56",

pages = "89--91",

journal = "Danish Medical Bulletin",

issn = "1603-9629",

publisher = "Almindelige Danske Laegeforening",

number = "2",

}

Bonjer, HJ, Lacy, AM, Haglind, E, Lange, JF, D'Hoore, A, Kurlberg, G, Hop, WCJ, Kuhry, E, Buunen, M, Rosenberg, J, Cuesta, MA, Fürst, A, Jess, P, Bulut, O, Poornoroozy, P, Juul Jensen, K, Christensen, MM, Lundhus, E, Evesen, H, Birch, D, Iesainieks, I, Jäger, C, Kreis, M, van Riet, YEA, van der Harst, E, Gerhards, MF, Bernelman, WA, Hansson, BME, Neijenhuis, PA, Prins, HA, Balague, C, Targarona, EM, Luján Mompeán, JA, Osorio, JDF, Molina, FJG, Skullman, S, Läckberg, Z, Kressner, U, Matthiessen, P, Kun, SH, Poza, AA, Inglis, K, Jeekel, J, Coenen, PPLO, Jakimowicz, JJ, Rosman, C, den Outer, AJ, Delgado, S, Påhlman, L & Kim, SH 2009, 'Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer', Danish Medical Bulletin, vol. 56, no. 2, pp. 89-91.

TY - JOUR

T1 - Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

AU - Bonjer, H. J.

AU - Lacy, A. M.

AU - Haglind, E.

AU - Lange, J. F.

AU - D'Hoore, A.

AU - Kurlberg, G.

AU - Hop, W. C.J.

AU - Kuhry, E.

AU - Buunen, M.

AU - Rosenberg, J.

AU - Cuesta, M. A.

AU - Fürst, A.

AU - Jess, P.

AU - Bulut, O.

AU - Poornoroozy, P.

AU - Juul Jensen, K.

AU - Christensen, M. Mark

AU - Lundhus, E.

AU - Evesen, H.

AU - Birch, D.

AU - Iesainieks, I.

AU - Jäger, C.

AU - Kreis, M.

AU - van Riet, Y. E.A.

AU - van der Harst, E.

AU - Gerhards, M. F.

AU - Bernelman, W. A.

AU - Hansson, B. M.E.

AU - Neijenhuis, P. A.

AU - Prins, H. A.

AU - Balague, C.

AU - Targarona, E. M.

AU - Luján Mompeán, J. A.

AU - Osorio, J. D.Franco

AU - Molina, F. J.Garcia

AU - Skullman, S.

AU - Läckberg, Z.

AU - Kressner, U.

AU - Matthiessen, P.

AU - Kun, S. H.

AU - Poza, A. Alfredo

AU - Inglis, K.

AU - Jeekel, J.

AU - Coenen, P. P.L.O.

AU - Jakimowicz, J. J.

AU - Rosman, C.

AU - den Outer, A. J.

AU - Delgado, S.

AU - Påhlman, L.

AU - Kim, S. H.

PY - 2009/5

Y1 - 2009/5

N2 - 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).

AB - 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).

UR - http://www.scopus.com/inward/record.url?scp=68849121478&partnerID=8YFLogxK

M3 - Artículo en revista científica indexada

C2 - 19486621

AN - SCOPUS:68849121478

SN - 1603-9629

VL - 56

SP - 89

EP - 91

JO - Danish Medical Bulletin

JF - Danish Medical Bulletin

IS - 2

ER -

Color II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

Abstract

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