title: The Study Centre of the German Surgical Society--rationale and current status.
abstract: BACKGROUND
  The concept of evidence-based medicine was introduced into surgery in the mid-1990s, initially focussing on the integration of best research evidence, surgeons' expertise and patients' value. The lack of relevant external evidence [randomised controlled trials (RCTs), systematic reviews] in favour of surgical procedures has led to the need for a new approach in clinical research.
  
  
  METHODS
  Development and implementation of the Study Centre of the German Surgical Society (SDGC) in order to design, perform and analyse multicentre randomised controlled trials in surgery.
  
  
  RESULTS
  The German Surgical Society has recently initiated four surgical RCTs within the SDGC in order to improve the national infrastructure for clinical research and its international scientific standing. All surgical trials focus on procedures in various fields (thyroid and parathyroid diseases, pancreatic surgery, abdominal wall closure) and are designed to fit the specific needs of each study (blinding of patients and assessors, ranking of endpoints, patients' perspective). Additionally, in a nationwide survey of 1,274 surgical departments in Germany, 307 replied, of which 237 (19%) were willing to participate in multicentre projects.
  
  
  CONCLUSIONS
  Evidence-based medicine has changed surgical practice, leading to an increase in demand for RCTs and requiring a new infrastructure in surgical departments and scientific societies.
authors.affiliation: Study Centre of the German Surgical Society, Department of Surgery, University of Heidelberg Medical School, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.
authors.forename: Hanns-Peter
authors.initials: HP
authors.lastname: Knaebel
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.forename: Moritz N
authors.initials: MN
authors.lastname: Wente
authors.forename: Hartwig
authors.initials: H
authors.lastname: Bauer
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.forename: Matthias
authors.initials: M
authors.lastname: Rothmund
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Seiler
mesh_terms: D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D013502:General Surgery; D005858:Germany; D006801:Humans; D012107:Research Design; D012955:Societies, Medical
references.citation: Br J Surg. 1997 Sep;84(9):1220-3
references.pmid: 9313697
references.citation: Am J Surg. 2002 Apr;183(4):399-405
references.pmid: 11975927
references.citation: BMJ. 2003 Dec 20;327(7429):1436-9
references.pmid: 14684638
references.citation: Surgery. 1996 Apr;119(4):466-72
references.pmid: 8644014
references.citation: Lancet. 1996 Apr 13;347(9007):984-5
references.pmid: 8606606
references.citation: BMC Surg. 2003 Nov 13;3:9
references.pmid: 14614782
references.citation: BMJ. 2004 Oct 30;329(7473):1017
references.pmid: 15514348
references.citation: World J Surg. 1999 Dec;23(12):1210-4
references.pmid: 10552108
references.citation: Dis Colon Rectum. 1993 Jan;36(1):43-8
references.pmid: 8416778
references.citation: Chirurg. 2004 Jul;75(7):706-7
references.pmid: 15098095
references.citation: BMJ. 1998 Aug 8;317(7155):362-3
references.pmid: 9694748
references.citation: Br J Surg. 2004 Jan;91(1):6-16
references.pmid: 14716788
references.citation: Br Med J. 1964 Feb 22;1(5381):455-60
references.pmid: 14084670
references.citation: Health Technol Assess. 1997;1(14 ):i-vi, 1-149
references.pmid: 9483162
references.citation: J R Soc Med. 2004 Mar;97(3):101-2
references.pmid: 14996952
references.citation: Dig Surg. 2003;20(4):263-9
references.pmid: 12748428
references.citation: Surgery. 1994 Jun;115(6):707-12
references.pmid: 8197563
references.citation: Chirurg. 2000 Jun;71(6):615-25
references.pmid: 10948728
references.citation: Lancet. 1996 Dec 14;348(9042):1631-9
references.pmid: 8984307
references.citation: Lancet. 2001 Apr 14;357(9263):1191-4
references.pmid: 11323066
references.citation: BMJ. 2002 Jun 15;324(7351):1448-51
references.pmid: 12065273
references.citation: BMJ. 1998 Oct 31;317(7167):1209-12
references.pmid: 9794861
references.citation: Med Clin North Am. 1975 Jul;59(4):1035-8
references.pmid: 1142862
references.citation: Lancet. 1996 Apr 13;347(9007):989-94
references.pmid: 8606612
references.citation: Surgery. 1980 Mar;87(3):258-62
references.pmid: 6987765
references.citation: Surgery. 1996 May;119(5):483-6
references.pmid: 8619200
references.citation: N Engl J Med. 1984 May 24;310(21):1363-7
references.pmid: 6717508
references.citation: Ann R Coll Surg Engl. 1992 Mar;74(2):80-4
references.pmid: 1567147