Skip to main content

Advertisement

SpringerLink
Log in

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

  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

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

    Article  PubMed  CAS  Google Scholar 

  2. 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):477–484

    Article  PubMed  Google Scholar 

  3. 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

    Google Scholar 

  4. 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):409–417

    Article  PubMed  CAS  Google Scholar 

  5. 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

    Google Scholar 

  6. 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):112–121

    PubMed  CAS  Google Scholar 

  7. 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–iv

    PubMed  CAS  Google Scholar 

  8. 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):1987–1991

    Article  PubMed  CAS  Google Scholar 

  9. 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):8–16

    Article  PubMed  Google Scholar 

  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):233–236

    Article  PubMed  CAS  Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

  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):94–100

    Article  PubMed  CAS  Google Scholar 

  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):298–303

    Article  PubMed  Google Scholar 

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

    Article  Google Scholar 

  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):1718–1726

    Article  PubMed  Google Scholar 

  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):2224–2229

    Article  PubMed  Google Scholar 

  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):1187–1192

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The authors are grateful to Marc Buunen, MD, Erasmus Medical Centre, Rotterdam, The Netherlands for providing necessary data from the COLOR trial files and to Harriet Törnqvist for meticulous technical support throughout the study. Professor Eva Haglind (principal investigator) had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Author information

Authors and Affiliations

  1. CLINTEC, Division of Surgery, Karolinska Institutet at Karolinska University Hospital Huddinge, K53, 141 86, Stockholm, Sweden

    Martin Janson

  2. Department of Surgery, Östersund Hospital, Ostersund, Sweden

    Gunnar Edlund

  3. Department of Surgery, Danderyd Hospital, Stockholm, Sweden

    Ulf Kressner

  4. Department of Surgery, Institute of Surgical Sciences, Göteborg University, Sahlgrenska University Hospital, Goteborg, Sweden

    Elisabet Lindholm & Eva Haglind

  5. Department of Surgery, University Hospital, Uppsala, Sweden

    Lars Påhlman

  6. Department of Surgery, Kärnsjukhuset, Skovde, Sweden

    Stefan Skullman

  7. Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital Solna, Stockholm, Sweden

    Bo Anderberg

Authors
  1. Martin Janson
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gunnar Edlund
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ulf Kressner
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Elisabet Lindholm
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Lars Påhlman
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Stefan Skullman
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Bo Anderberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Eva Haglind
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Martin Janson.

Additional information

This work was supported by grants from the Swedish Cancer Society (Project Number 4287-B01-03XCC and Project Number 1921-B03-21XCC), the County Council of Stockholm, Assar Gabrielsson’s Foundation for Clinical Research, Jubileumskliniken Research Foundation, Sahlgrenska University Hospital and the Swedish Society of Medicine.

A preliminary version of this paper was previously published in an academic thesis; “Laparoscopic and open surgery for colon cancer. Studies on costs and health related quality of life” by Martin Janson, Karolinska Institutet 2006, ISBN 91-7140-782-0.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Janson, M., Edlund, G., Kressner, U. et al. Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial. Surg Endosc 23, 1764–1769 (2009). https://doi.org/10.1007/s00464-008-0203-7

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-008-0203-7

Keywords

Search

Navigation