Top

Published in:

01-08-2009

Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial

Authors: Martin Janson, Gunnar Edlund, Ulf Kressner, Elisabet Lindholm, Lars Påhlman, Stefan Skullman, Bo Anderberg, Eva Haglind

Published in: Surgical Endoscopy | Issue 8/2009

Abstract

Objective

The colon cancer laparoscopic or open resection (COLOR) trial is an international, randomised controlled trial comparing outcomes of open and laparoscopic surgery for colon cancer. The main purpose of this study was to determine representability by comparing included and nonincluded patients in the participating Swedish centres.

Design

At eight centres, which included 391 of the 422 Swedish patients, a local database search was performed to identify retrospectively all patients (n = 2,384) who underwent surgery for colon cancer during the inclusion period, and data was retrieved from medical records.

Results

Four hundred fifty-six patients were randomised, 65 of whom were excluded post randomisation (group 2), leaving 391 patients in the study (group 1). For 1,566 patients, valid exclusion criteria were found (group 3). Thus, 362 patients were eligible but not included (group 4). Relative to group 1, patients in group 4 had a significantly higher American Society of Anaesthesiologists (ASA) score, more advanced tumour stage and difference regarding the resections performed. Results showed that 1470 patients (62%) could be calculated as feasible for laparoscopic colon resection (LCR) in a clinical, nontrial situation.

Conclusions

The study population in the Swedish part of the COLOR trial was representative of the eligible population with the exception of comorbidity, where those actually included had less severe comorbidity than the nonincluded but eligible patients. In Sweden, 50–60% of colon cancer patients can be operated on by laparoscopy.

Hazebroek EJ (2002) COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer. Surg Endosc 16(6):949–953PubMedCrossRef

Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy AM, Lacy A, Delgado S (2005) Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 6(7):477–484PubMedCrossRef

Kuhry E, Bonjer HJ, Haglind E, Hop WC, Veldkamp R, Cuesta MA, Jeekel J, Pahlman L, Morino M, Lacy A, Delgado S (2005) Impact of hospital case volume on short-term outcome after laparoscopic operation for colonic cancer. Surg Endosc 19(5):687–692. Epub 2005 Mar 30

Janson M, Bjorholt I, Carlsson P, Haglind E, Henriksson M, Lindholm E, Anderberg B (2004) Randomized clinical trial of the costs of open and laparoscopic surgery for colonic cancer. Br J Surg 91(4):409–417PubMedCrossRef

Janson M, Lindholm E, Anderberg B, Haglind E (2007) Randomized trial of health-related quality of life after open and laparoscopic surgery for colon cancer. Surg Endosc 21(5):747–753. Epub 2007 Mar 7

Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C (1999) Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy 4(2):112–121PubMed

King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R (2005) Conceptual framework and systematic review of the effects of participants’ and professionals’ preferences in randomised controlled trials. Health Technol Assess 9(35):1–186, iii–ivPubMed

Moher D, Schulz KF, Altman D (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285(15):1987–1991PubMedCrossRef

Kennedy WA, Laurier C, Malo JL, Ghezzo H, L’Archeveque J, Contandriopoulos AP (2003) Does clinical trial subject selection restrict the ability to generalize use and cost of health services to “real life” subjects? Int J Technol Assess Health Care 19(1):8–16PubMedCrossRef

10.

International statistical classification of diseases and related health problems, tenth revision (ICD–10), Swedish Version. The National Board of Health and Welfare, Stockholm (1996)

11.

Keats AS (1978) The ASA classification of physical status—a recapitulation. Anesthesiology 49(4):233–236PubMedCrossRef

12.

Corman M (2005) Colon and rectal surgery, 5th edn. Lippincott, Williams & Wilkins, Philadelphia

13.

Gordon PH, Nivatvongs S (1997) Principles and practice of surgery for the colon, rectum and anus. Quality Medical, St. Louis

14.

Jestin P (2005) Colorectal cancer. Audit and health economy in colorectal cancer surgery in a defined Swedish population. Uppsala University, Uppsala

15.

Jestin P, Nilsson J, Heurgren M, Pahlman L, Glimelius B, Gunnarsson U (2005) Emergency surgery for colonic cancer in a defined population. Br J Surg 92(1):94–100PubMedCrossRef

16.

Bonjer HJ, Hop WC, Nelson H, Sargent DJ, Lacy AM, Castells A, Guillou PJ, Thorpe H, Brown J, Delgado S, Kuhrij E, Haglind E, Pahlman L (2007) Laparoscopically assisted vs open colectomy for colon cancer: a meta-analysis. Arch Surg 142(3):298–303PubMedCrossRef

17.

COST study group (2004) A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350(20):2050–2059CrossRef

18.

Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM (2005) Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 365(9472):1718–1726PubMedCrossRef

19.

Lacy AM, Garcia-Valdecasas JC, Delgado S, Castells A, Taura P, Pique JM, Visa J (2002) Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer: a randomised trial. Lancet 359(9325):2224–2229PubMedCrossRef

20.

Leung KL, Kwok SP, Lam SC, Lee JF, Yiu RY, Ng SS, Lai PB, Lau WY (2004) Laparoscopic resection of rectosigmoid carcinoma: prospective randomised trial. Lancet 363(9416):1187–1192PubMedCrossRef

Title: Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial
Authors: Martin Janson
Gunnar Edlund
Ulf Kressner
Elisabet Lindholm
Lars Påhlman
Stefan Skullman
Bo Anderberg
Eva Haglind
Publication date: 01-08-2009
Publisher: Springer-Verlag
Published in: Surgical Endoscopy / Issue 8/2009
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-008-0203-7

At a glance: The STEP trials

Springer Medicine

Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial

Abstract

Objective

Design

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Objective

Design

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 8/2009

Radiation exposure during laparoscopic cholecystectomy with routine intraoperative cholangiography

Laparoscopic completely extraperitoneal repair of inguinal hernia in children: a single-institute experience with 1,257 repairs compared with cut-down herniorrhaphy

Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study

General complications following laparoscopic-assisted gastrectomy and analysis of techniques to manage them

Laparoscopically assisted ileocolectomy in patients with Crohn’s disease: a study of 50 consecutive patients

Endoscopic full-thickness resection with laparoscopic assistance as hybrid NOTES for gastric submucosal tumor