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Randomised Clinical Trials in Surgery: A Look at the Ethical and Practical Issues

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Abstract

An ethically conducted randomised controlled trial (RCT) is the backbone of evidence based medicine. In surgical practice however, RCTs have taken a backseat, drawing much adverse comment. There are several reasons to explain surgeons’ disinclination to conduct RCTs. These include many practical difficulties such as the problem of blinding surgical procedures, design and funding issues. There are also many ethical issues which need to be considered including the concept of equipoise as well as the ethical issues associated with sham surgery as a control. While there is no doubt that RCTs are essential and in fact have helped to weed out several unnecessary surgical procedures, it is important not to lose sight of the fact that they may not be always necessary in order to obtain evidence in favour of a procedure. Possible solutions could be to follow guidelines that have been issued by learned bodies and a strict adherence to all ethical norms that have been recommended in the conduct of trials

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References

  1. http://www.law.umkc.edu/faculty/projects/ftrials/nuremberg/NurembergDoctorTrial.html (accessed 22october, 2010)

  2. Beecher HK (1966) Ethics and clinical research. New Eng J Med 274:1354–1360

    Article  PubMed  CAS  Google Scholar 

  3. Rickham PP (1964) Human experimentation. code of ethics of the world medical association, declaration of Helsinki. Br Med J 2(5402):177

    Article  PubMed  CAS  Google Scholar 

  4. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (2007) Evidence based medicine: what it is and what it isn't. Clin Orthop Relat Res 455:3–5

    PubMed  Google Scholar 

  5. Horton R (1996) Surgical research or comic opera: questions, but few answers. Lancet 347(9007):984–985

    Article  PubMed  CAS  Google Scholar 

  6. The EC/IC Bypass Study Group (1985) Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med 313:1191–1200

    Article  Google Scholar 

  7. Cobb LA, Thomas GI, Dillard DH, Merndino KA, Bruce RA (1959) An evaluation of internal mammary-artery ligation by a double-blind technic. N Engl J Med 260:1115–1118

    Article  PubMed  CAS  Google Scholar 

  8. Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH et al (2002) A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 347:81–88

    Article  PubMed  Google Scholar 

  9. Law S, Fok M, Chu KM, Wong J (1997) Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer. A prospective randomized controlled trial. Ann Surg 226:169–173

    Article  PubMed  CAS  Google Scholar 

  10. Majeed AW, Troy G, Nicholls P, Smythe A, Reed MW, Stoddard CJ, Peacock J, Johnson AG (1996) Randomized prospective single blind comparison of laparoscopic versus small incision cholecystectomy. Lancet 347:989–994

    Article  PubMed  CAS  Google Scholar 

  11. Slim K, Bousquet J, Kwiatkowski F, Pezet D, Chipponi J (1997) Analysis of randomized controlled trials in laparoscopic surgery. BrJ Surg 84:610–614

    Article  CAS  Google Scholar 

  12. Johnson AJ, Dixon JM (1997) Removing bias in surgical trials. BMJ 314(7085):916–917

    Article  PubMed  CAS  Google Scholar 

  13. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ 324:1448–1451

    Article  PubMed  Google Scholar 

  14. Goligher JC, Pulvertaft CN, De Bombal FT, Conyers JH, Duthie HL, Feather DB et al (1968) Five to eight year results of Leeds/York controlled trial of elective surgery for duodenal ulcer. BMJ 2:781–787

    Article  PubMed  CAS  Google Scholar 

  15. Goligher JC, Feather DB, Hall R, Hal RA, Hopton D, Kenny TE et al (1979) Several standard elective operations for duodenal ulcer: ten to sixteen year clinical results. Ann Surg 189:18–24

    Article  PubMed  CAS  Google Scholar 

  16. Djulbegovic B (2009) The paradox of equipoise: the principle that drives and limits therapeutic discoveries in clinical research. Cancer Control 16(4):342–347

    PubMed  Google Scholar 

  17. Freedman B (2006) Equipose and the ethics of clinical research. In: Kuhse H, Singer P (eds) Bioethics: an anthology, 2nd edn. Blackwell Publishers, Malden

    Google Scholar 

  18. Gelijns AC, Ascheim DD, Parides MK, Kent KC, Moskowitz AJ (2009) Randomized trials in surgery. Surgery 145(6):581–587

    Article  PubMed  Google Scholar 

  19. Rettig RA, Jacobsen PD, Farquhar CM, Aubry WM (2007) False hope: bone marrowtransplantation for breast cancer. Oxford University Press, New York

    Google Scholar 

  20. Mc Culloch P (1999) Evidence based surgery: do we need it, and can we get it? http://ktclearinghouse.ca/cebm/syllabi/gensurgery/intro (accessed 22/10/10)

  21. Polgar S (2006) Evidence based methodology for advancing neural reconstruction. In: Sanberg CD, Sanberg PR (eds) Cell therapy, stem cells and brain repair. Humana Press, Totowa, pp 325–339

    Google Scholar 

  22. Miller FG (2003) Sham surgery: an ethical analysis. Sci Eng Ethics 10(1):157–166

    Article  Google Scholar 

  23. Polgar S, Ng J (2005) Ethics, methodology and the use of placebo controls in surgical trials. Brain Res Bull 67:290–297

    Article  PubMed  Google Scholar 

  24. Emmanuel EJ, Miller FG (2001) The ethics of placebo-controlled trials—a middle ground. New Engl J Med 345:915–919

    Article  Google Scholar 

  25. Wolf BR, Buckwalter JA (2006) Randomised surgical trials and sham surgery: relevance to modern orthopedic and minimally invasive surgery. Iowa Orthop J 26:107–111

    PubMed  Google Scholar 

  26. Tenery R, Rakatansky H, Riddick Frank A, Goldrich M, Morse LJ, O’Bannon JM et al (2002) Surgical placebo controls. Ann Surg 235(2):303–307

    Article  PubMed  Google Scholar 

  27. Menasche P (2010) Cardiac cell therapy: Lessons from clinical trials: J Mol Cell Cardiol [Epub ahead of print]

  28. Gejlins AC, Aschleim DD, Parides MK, Kent KG, Moskowitz AJ (2009) Randomised trials in Surgery. Surgery 145(6):581–587

    Article  Google Scholar 

  29. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW, Investigators SYNTAX (2009) Percutaneous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med 360:961–972

    Article  PubMed  CAS  Google Scholar 

  30. Parides MK, Moskowitz AJ, Ascheim DD, Rose EA, Gelijns AC (2006) Progress versusprecision: challenges in clinical trial design for left ventricular assist devices. Ann Thorac Surg 82:1140–1146

    Article  PubMed  Google Scholar 

  31. Park SJ, Gelijns AC, Moskowitz AJ, Frazier OH, Piccioni W, Raines E et al (2005) LVADs as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 129:9–17

    Article  PubMed  Google Scholar 

  32. Thompson DF (1993) Understanding financial conflicts of interest. N Engl J Med 329:573–576

    Article  PubMed  CAS  Google Scholar 

  33. McDonald PJ, Kulkarni AV, Farrokhyar F, Bhandari M (2010) Ethical issues in surgical research. Can J Surg 53:133–136

    PubMed  Google Scholar 

  34. Van Rij AM, McDonald JR, Pettigrew RA, Putterill MJ, Reddy CK, Wright JJ (1995) CUSUM as an aid to early assessment of the surgical trainee. Br J Surg 82:1500–1503

    Article  PubMed  Google Scholar 

  35. Poloniecki J, Valencia O, Littlejohns P (1998) Cumulative risk adjusted mortality chart for detecting changes in death rate: observational study of heart surgery. BMJ 316:1697–1700

    Article  PubMed  CAS  Google Scholar 

  36. Lovegrove J, Valencia O, Treasure T, Sherlaw-Johnson C, Gallivan S (1997) Monitoring the results of cardiac surgery by variable life­adjusted display. Lancet 350:1128–1130

    Article  PubMed  CAS  Google Scholar 

  37. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T. CONSORT GROUP (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134(8):663–694

    Google Scholar 

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  1. Clinical Research Leader, Stempeutics Research Malaysia, Kuala Lumpur, Malaysia

    Anjan Kumar Das

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  1. Anjan Kumar Das
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Correspondence to Anjan Kumar Das.

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Das, A.K. Randomised Clinical Trials in Surgery: A Look at the Ethical and Practical Issues. Indian J Surg 73, 245–250 (2011). https://doi.org/10.1007/s12262-011-0307-5

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  • DOI: https://doi.org/10.1007/s12262-011-0307-5

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