Langenbeck's Archives of Surgery

, Volume 397, Issue 8, pp 1193–1199

Surgical evaluation and knowledge transfer—methods of clinical research in surgery

  • Markus K. Diener
  • Thomas Simon
  • Markus W. Büchler
  • Christoph M. Seiler
Review Article



This article aims to outline the framework of surgical evaluation and knowledge transfer. Therefore, special design issues affecting surgical clinical research will be discussed. Moreover, principles and challenges of knowledge transfer from research into practice will be addressed.


The ultimate goal of academic surgery is to improve surgical and perioperative care in order to achieve the best outcomes for patients. Randomized controlled trials and reviews with and without meta-analyses are fundamental requirements for evidence-based decision making.


Despite calls for more rigorous research methods in surgery, the frequency of high-quality randomized controlled trials and systematic reviews is low. Specific methodological and design issues have to be implemented for valid evaluation of surgical procedures. Thus, general catchwords of clinical epidemiology such as timing, randomization, registration, and reporting standards demand special appraisal. Moreover, blinding methods, placebo controls, learning curves, standardized outcome assessment, and generalizability are critical design issues in surgical trials. Moreover, systematic reviews and meta-analyses are desirable for answering clinical issues or defining new research questions.


For a rigorous evaluation of surgical procedures, a basic understanding of research methodology is urgently needed, and to improve methodological expertise, collaboration between surgeons and methodologists is encouraged.


Evidence-based surgery Surgery Randomized controlled trials Meta-analyses Knowledge transfer 


  1. 1.
    Seiler CM, Diener MK, Schuhmacher C (2010) Impact of clinical trials for surgery. Chirurg 81:334–340PubMedCrossRefGoogle Scholar
  2. 2.
    Schneider M, Weitz J, Buchler MW (2010) The focus of Langenbeck’s Archives of Surgery in the 21st century. Langenbecks Arch Surg 395(Suppl 1):75–79PubMedCrossRefGoogle Scholar
  3. 3.
    Antes G, Sauerland S, Seiler CM (2006) Evidence-based medicine—from best research evidence to a better surgical practice and health care. Langenbecks Arch Surg 391:61–67PubMedCrossRefGoogle Scholar
  4. 4.
    Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA et al (2009) Challenges in evaluating surgical innovation. Lancet 374:1097–1104PubMedCrossRefGoogle Scholar
  5. 5.
    Diener MK, Seiler CM, Antes G (2007) Systematic reviews and meta-analyses in surgery. Chirurg 78:938–944PubMedCrossRefGoogle Scholar
  6. 6.
    Wente MN, Seiler CM, Uhl W, Buchler MW (2003) Perspectives of evidence-based surgery. Dig Surg 20(4):263–269PubMedCrossRefGoogle Scholar
  7. 7.
    Solomon MJ, Laxamana A, Devore L, McLeod RS (1994) Randomized controlled trials in surgery. Surgery 115:707–712PubMedGoogle Scholar
  8. 8.
    Hall JC, Mills B, Nguyen H, Hall JL (1996) Methodologic standards in surgical trials. Surgery 119:466–472PubMedCrossRefGoogle Scholar
  9. 9.
    Abraham NS (2006) Will the dilemma of evidence-based surgery ever be resolved? ANZ J Surg 76:855–860PubMedCrossRefGoogle Scholar
  10. 10.
    Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD et al (2000) Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 283:2008–2012PubMedCrossRefGoogle Scholar
  11. 11.
    Clarke M (2004) Doing new research? Don’t forget the old. PLoS Med 1(2):e35PubMedCrossRefGoogle Scholar
  12. 12.
    Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG (2004) Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 291:2457–2465PubMedCrossRefGoogle Scholar
  13. 13.
    DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J et al (2004) Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 292:1363–1364PubMedCrossRefGoogle Scholar
  14. 14.
    Antes G, Chalmers I (2003) Under-reporting of clinical trials is unethical. Lancet 361:978–979PubMedCrossRefGoogle Scholar
  15. 15.
    Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 148:295–309PubMedGoogle Scholar
  16. 16.
    Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC et al (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med 6:e1000100PubMedCrossRefGoogle Scholar
  17. 17.
    Clarke M, Hopewell S, Chalmers I (2010) Clinical trials should begin and end with systematic reviews of relevant evidence: 12 years and waiting. Lancet 376:20–21PubMedCrossRefGoogle Scholar
  18. 18.
    Pocock S (1983) Clinical trials: a practical approach. Methods of randomisation. Wiley, New York, pp 66–90Google Scholar
  19. 19.
    Altman DG, Bland JM (1999) Statistics notes. Treatment allocation in controlled trials: why randomise? BMJ 318:1209PubMedCrossRefGoogle Scholar
  20. 20.
    Chalmers TC (1975) Randomization of the first patient. Med Clin North Am 59:1035–1043PubMedGoogle Scholar
  21. 21.
    Meakins JL (2002) Innovation in surgery: the rules of evidence. Am J Surg 183:399–405PubMedCrossRefGoogle Scholar
  22. 22.
    McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ 324:1448–1451PubMedCrossRefGoogle Scholar
  23. 23.
    Cook JA (2009) The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 10:9PubMedCrossRefGoogle Scholar
  24. 24.
    Russell I (1995) Evaluating new surgical procedures. BMJ 311:1243–1247PubMedCrossRefGoogle Scholar
  25. 25.
    Altman DG, Schulz KF (2001) Statistics notes: concealing treatment allocation in randomised trials. BMJ 323:446–453PubMedCrossRefGoogle Scholar
  26. 26.
    Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M et al (2010) Randomized controlled trials of surgical interventions. Ann Surg 251:409–416PubMedCrossRefGoogle Scholar
  27. 27.
    Seiler CM, Deckert A, Diener MK, Knaebel HP, Weigand MA et al (2009) Midline versus transverse incision in major abdominal surgery: a randomized, double-blind equivalence trial (POVATI: ISRCTN60734227). Ann Surg 249:913–920PubMedCrossRefGoogle Scholar
  28. 28.
    Majeed AW, Troy G, Nicholl JP, Smythe A, Reed MW et al (1996) Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet 347:989–994PubMedCrossRefGoogle Scholar
  29. 29.
    Diener MK, Blumle A, Szakallas V, Antes G, Seiler CM (2006) Randomized and nonrandomized controlled clinical trials in a German surgical journal. Chirurg 77:837–843PubMedCrossRefGoogle Scholar
  30. 30.
    Karanicolas PJ, Bhandari M, Taromi B, Akl EA, Bassler D et al (2008) Blinding of outcomes in trials of orthopaedic trauma: an opportunity to enhance the validity of clinical trials. J Bone Joint Surg Am 90:1026–1033PubMedCrossRefGoogle Scholar
  31. 31.
    Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA et al (2002) A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 347:81–88PubMedCrossRefGoogle Scholar
  32. 32.
    Swank DJ, Swank-Bordewijk SC, Hop WC, van Erp WF, Janssen IM et al (2003) Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi-centre trial. Lancet 361:1247–1251PubMedCrossRefGoogle Scholar
  33. 33.
    Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA (1959) An evaluation of internal-mammary-artery ligation by a double-blind technic. N Engl J Med 260:1115–1118PubMedCrossRefGoogle Scholar
  34. 34.
    Diener MK, Knaebel HP, Witte ST, Rossion I, Kieser M et al (2008) DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy—study rationale and design. Clin Trials 5:534–545PubMedCrossRefGoogle Scholar
  35. 35.
    Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ et al (2007) Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 142(5):761–768PubMedCrossRefGoogle Scholar
  36. 36.
    Bonenkamp JJ, Songun I, Hermans J, Sasako M, Welvaart K et al (1995) Randomised comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients. Lancet 345:745–748PubMedCrossRefGoogle Scholar
  37. 37.
    Bruns H, Rahbari NN, Loffler T, Diener MK, Seiler CM et al (2009) Perioperative management in distal pancreatectomy: results of a survey in 23 European participating centres of the DISPACT trial and a review of literature. Trials 10:58PubMedCrossRefGoogle Scholar
  38. 38.
    Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ et al (2005) Need for expertise based randomised controlled trials. BMJ 330:88–91PubMedCrossRefGoogle Scholar
  39. 39.
    Heritier SR, Gebski VJ, Keech AC (2003) Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust 179:438–440PubMedGoogle Scholar
  40. 40.
    Peto R, Collins R, Gray R (1995) Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol 48:23–40PubMedCrossRefGoogle Scholar
  41. 41.
    McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P et al (2009) No surgical innovation without evaluation: the IDEAL recommendations. Lancet 374:1105–1112PubMedCrossRefGoogle Scholar
  42. 42.
    Diener MK, Wolff RF, von Elm E, Rahbari NN, Mavergames C et al (2009) Can decision making in general surgery be based on evidence? An empirical study of Cochrane Reviews. Surgery 146:444–461PubMedCrossRefGoogle Scholar
  43. 43.
    Young C, Horton R (2005) Putting clinical trials into context. Lancet 366:107–108PubMedCrossRefGoogle Scholar
  44. 44.
    Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM (2010) Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg 251:843–856PubMedCrossRefGoogle Scholar
  45. 45.
    Diener MK, Mehr KT, Wente MN, Kieser M, Buchler MW et al (2011) Risk-benefit assessment of closed intra-abdominal drains after pancreatic surgery: a systematic review and meta-analysis assessing the current state of evidence. Langenbecks Arch Surg 396:41–52PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Markus K. Diener
    • 1
    • 2
  • Thomas Simon
    • 1
  • Markus W. Büchler
    • 1
  • Christoph M. Seiler
    • 1
    • 2
  1. 1.Department of General, Visceral and Transplantation SurgeryUniversity of HeidelbergHeidelbergGermany
  2. 2.Study Centre of the German Surgical SocietyUniversity of HeidelbergHeidelbergGermany

Personalised recommendations