Surgery
Volume 145, Issue 6 , Pages 590-597 , June 2009

Coordinating a National Clinical Trials Center: The German experience

  • Christoph M. Seiler, MD, MSc

      Affiliations

    • Department of General Surgery, University of Heidelberg, Heidelberg, Germany
    • Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany
    • ,
  • Markus K. Diener, MD

      Affiliations

    • Department of General Surgery, University of Heidelberg, Heidelberg, Germany
    • Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany
    • ,
  • Nuh Rahbari, MD

      Affiliations

    • Department of General Surgery, University of Heidelberg, Heidelberg, Germany
    • Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany
    • ,
  • Hartwig Bauer, MD

      Affiliations

    • Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany
    • German Surgical Society, Berlin, Germany
    • ,
  • Matthias Rothmund, MD

      Affiliations

    • Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany
    • Department of Surgery, University of Marburg, Marburg, Germany
    • ,
  • Markus W. Büchler, MD

      Affiliations

    • Department of General Surgery, University of Heidelberg, Heidelberg, Germany
    • Corresponding Author InformationReprint requests: Markus W. Büchler, MD, Study Center of the German Surgical Society, University of Heidelberg, Im Neuenheimer Feld 110, D-69120 Heidelberg, Germany

,Accepted 3 March 2009.

References 

  1. McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999;1210–1214
  2. Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise based randomised controlled trials. BMJ. 2005;330:88–91
  3. Hu X, Wright JG, McLeod RS, et al. Observational studies as alternatives to randomized clinical trials in surgical clinical research. Surgery. 1996;119:473–475
  4. Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005;365:82–93
  5. Knaebel HP, Diener MK, Wente MN, et al. The Study Centre of the German Surgical Society—rationale and current status. Langenbecks Arch Surg. 2005;390:171–177
  6. Wente MN, Seiler CM, Uhl W, Buchler MW. Perspectives of evidence-based surgery. Dig Surg. 2003;20:263–269
  7. Rahbari NN, Diener MK, Fischer L, et al. A concept for trial institutions focusing on randomised controlled trials in surgery. Trials. 2008;9:3
  8. van GJ. The Netherlands. Randomised trials. Lancet. 1996;347:1234–1235
  9. You YN, Hunt KK, Posner MC, et al. Operative trials: the opportunity beckons—an update on the American College of Surgeons Oncology Group. Surgery. 2006;139:455–459
  10. Seiler CM, Wente MN, Diener MK, et al. Center for clinical studies in a surgical department—an approach for more evidence-based medicine. Contemp Clin Trials. 2006;27:211–214
  11. Sim I, Chan AW, Gulmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet. 2006;367:1631–1633
  12. Fischer L, Brukner T, Diener MK, Kadmon M, Wente MN, Sauerland S, et al. Four years of teaching principles in clinical trials—a continuous evaluation of the postgraduate workshop for surgical investigators at the study center of the German Surgical Society. J Surg Educ. 2009;66:15–19
  13. Wente MN, Fischer L, Seiler CM. [Multicentric randomised controlled trials in Germany: overview and interim analysis 1 year after inclusion of in the rubric “Clinical Trials”]. Chirurg. 2008;79:361–364
  14. Knaebel HP, Koch M, Sauerland S, Diener MK, Buchler MW, Seiler CM. Interrupted or continuous slowly absorbable sutures—design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial. [ISRCTN24023541] BMC Surg. 2005;5:3
  15. Seiler CM, Kellmeyer P, Kienle P, Buchler MW, Knaebel HP. Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial. J Med Ethics. 2007;33:113–118
  16. Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, et al. Interrupted or Continuous Slowly Absorbable Sutures for Closure of Primary Elective Midline Abdominal Incisions: A Multicenter Randomized Trial (INSECT: ISRCTN24023541). Ann Surg. 2009 Mar 18;[Epub ahead of print]
  17. Seiler CM, Frohlich BE, Veit JA, Gazyakan E, Wente MN, Wollermann C, et al. Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery. Trials. 2006;7:27
  18. Schlosser K, Veit JA, Witte S, Fernandez ED, Victor N, Knaebel HP, et al. Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial. Trials. 2007;8:22
  19. Diener MK, Knaebel HP, Witte St, Buchler MW, Seiler CM and the DISPACT Trial Group. DISPACT trial: a randomized controlled trial to compare two different surgical techniques of DIStal PAnCreaTectomy—study rationale and design. [ISRCTN18452029] Clin Trials. 2008;5:543–545
  20. Knaebel HP, Diener MK, Wente MN, Buchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005;92:539–546
  21. Sauerland S, Seiler CM. Role of systematic reviews and meta-analysis in evidence-based medicine. World J Surg. 2005;582–587
  22. Diener MK, Rahbari NN, Fischer L, Antes G, Büchler MW, Seiler CM. Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for surgical treatment of chronic pancreatitis—a systematic review and meta-analysis. Ann Surg. 2008;247:6
  23. Michalski CW, Kleeff J, Wente MN, Diener MK, Buchler MW, Friess H. Systematic review and meta-analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer. Br J Surg. 2007;94:265–273
  24. Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, et al. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007;193:171–183
  25. Diener MK, Knaebel HP, Heukaufer C, Antes G, Buchler MW, Seiler CM. A systematic review and meta-analysis of pylorus-preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma. Ann Surg. 2007;245:187–200

 The infrastructure of the SDGC is funded by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]; 01GH99033) and the German Surgical Society (Deutsche Gesellschaft für Chirurgie [DGCH]). Additional industrial funding for the infrastructure is received from Johnson & Johnson Medical GmbH, Norderstedt, Germany, Covidien Healthcare Deutschland GmbH, Neustadt, Germany, and BBD Aesulap GmbH, Tuttlingen, Germany.

 C.M.S. and M.K.D. contributed equally to the preparation of the manuscript.

PII: S0039-6060(09)00105-6

doi: 10.1016/j.surg.2009.03.001

Surgery
Volume 145, Issue 6 , Pages 590-597 , June 2009

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