Coordinating a National Clinical Trials Center: The German experience

Surgery

Volumn 145, Issue 6, 2009, Pages 590-597

  Seiler, Christoph M ^a   Diener, Markus K ^a   Rahbari, Nuh ^a   Bauer, Hartwig ^a,b   Rothmund, Matthias ^a,c   Büchler, Markus W ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b German Cancer Society   (Germany)

^c PHILIPPS UNIVERSITY MARBURG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ABDOMINAL SURGERY; CAST APPLICATION; CHRONIC PANCREATITIS; CLINICAL RESEARCH; CLINICAL TRIAL; EDITORIAL; EVIDENCE BASED MEDICINE; FUNDING; GERMANY; HUMAN; INTERMETHOD COMPARISON; LAPAROTOMY; MEDICAL SOCIETY; METHODOLOGY; NATIONAL HEALTH ORGANIZATION; OPEN REDUCTION; ORGANIZATION AND MANAGEMENT; OSTEOSYNTHESIS; OUTCOME ASSESSMENT; PANCREAS SURGERY; PARATHYROIDECTOMY; PATIENT CARE; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH ETHICS; SURGEON; SURGICAL TECHNIQUE; SUTURING METHOD; THYROID SURGERY;

CLINICAL TRIALS AS TOPIC; FOUNDATIONS; GERMANY; HUMANS; PILOT PROJECTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SCIENCE; SOCIETIES, MEDICAL; SURGICAL PROCEDURES, OPERATIVE;

EID: 66049085476     PISSN: 00396060     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.surg.2009.03.001     Document Type: Editorial

References (25)

1. McLeod R.S. Issues in surgical randomized controlled trials. World J Surg (1999) 1210-1214
2. Devereaux P.J., Bhandari M., Clarke M., et al. Need for expertise based randomised controlled trials. BMJ 330 (2005) 88-91
3. Hu X., Wright J.G., McLeod R.S., et al. Observational studies as alternatives to randomized clinical trials in surgical clinical research. Surgery 119 (1996) 473-475
4. Rothwell P.M. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet 365 (2005) 82-93
5. Knaebel H.P., Diener M.K., Wente M.N., et al. The Study Centre of the German Surgical Society-rationale and current status. Langenbecks Arch Surg 390 (2005) 171-177
6. Wente M.N., Seiler C.M., Uhl W., and Buchler M.W. Perspectives of evidence-based surgery. Dig Surg 20 (2003) 263-269
7. Rahbari N.N., Diener M.K., Fischer L., et al. A concept for trial institutions focusing on randomised controlled trials in surgery. Trials 9 (2008) 3
8. van G.J. The Netherlands. Randomised trials. Lancet 347 (1996) 1234-1235
9. You Y.N., Hunt K.K., Posner M.C., et al. Operative trials: the opportunity beckons-an update on the American College of Surgeons Oncology Group. Surgery 139 (2006) 455-459
10. Seiler C.M., Wente M.N., Diener M.K., et al. Center for clinical studies in a surgical department-an approach for more evidence-based medicine. Contemp Clin Trials 27 (2006) 211-214
11. Sim I., Chan A.W., Gulmezoglu A.M., Evans T., and Pang T. Clinical trial registration: transparency is the watchword. Lancet 367 (2006) 1631-1633
12. Fischer L., Brukner T., Diener M.K., Kadmon M., Wente M.N., 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 66 (2009) 15-19
13. Wente M.N., Fischer L., and Seiler C.M. [Multicentric randomised controlled trials in Germany: overview and interim analysis 1 year after inclusion of in the rubric "Clinical Trials"]. Chirurg 79 (2008) 361-364
14. Knaebel H.P., Koch M., Sauerland S., Diener M.K., Buchler M.W., and Seiler C.M. Interrupted or continuous slowly absorbable sutures-design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial. [ISRCTN24023541]. BMC Surg 5 (2005) 3
15. Seiler C.M., Kellmeyer P., Kienle P., Buchler M.W., and Knaebel H.P. Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial. J Med Ethics 33 (2007) 113-118
16. Seiler C.M., Bruckner T., Diener M.K., 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 C.M., Frohlich B.E., Veit J.A., Gazyakan E., Wente M.N., 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 7 (2006) 27
18. Schlosser K., Veit J.A., Witte S., Fernandez E.D., Victor N., Knaebel H.P., 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 8 (2007) 22
19. Diener M.K., Knaebel H.P., Witte S., Buchler M.W., Seiler C.M., and 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 5 (2008) 543-545
20. Knaebel H.P., Diener M.K., Wente M.N., Buchler M.W., and Seiler C.M. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg 92 (2005) 539-546
21. Sauerland S., and Seiler C.M. Role of systematic reviews and meta-analysis in evidence-based medicine. World J Surg (2005) 582-587
22. Diener M.K., Rahbari N.N., Fischer L., Antes G., Büchler M.W., and Seiler C.M. Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for surgical treatment of chronic pancreatitis-a systematic review and meta-analysis. Ann Surg 247 (2008) 6
23. Michalski C.W., Kleeff J., Wente M.N., Diener M.K., Buchler M.W., and Friess H. Systematic review and meta-analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer. Br J Surg 94 (2007) 265-273
24. Wente M.N., Shrikhande S.V., Muller M.W., Diener M.K., Seiler C.M., Friess H., et al. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg 193 (2007) 171-183
25. Diener M.K., Knaebel H.P., Heukaufer C., Antes G., Buchler M.W., and Seiler C.M. A systematic review and meta-analysis of pylorus-preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma. Ann Surg 245 (2007) 187-200