The Study Centre of the German Surgical Society: Current Trials and Results

Overview

Journal Langenbecks Arch Surg

Specialty General Surgery

Date 2012 Mar 1

PMID 22374105

Citations 4

Authors

Phillip Knebel

Shafreena Kuhn

Alexis B Ulrich

Markus W Buchler

Markus K Diener

Affiliations

Soon will be listed here.

Abstract

Purpose: This article provides an overview of current and completed multicentre trials and systematic reviews performed by the Study Centre of the German Surgical Society (SDGC).

Background: The SDGC aims to transfer the concept of evidence-based medicine to surgery by planning, conducting and analyzing large national and international randomized multicentre trials concerning surgical issues. Every German surgeon may ask the SDGC for support to realize his clinical trial ideas. Another important task of the SDGC is the acquisition of trial funding from government institutions or industrial partners.

Discussion: Five multicentre randomized controlled trials (RCT) and 11 systematic reviews with meta-analyses have already been completed and published by the SDGC. Another seven RCTs are currently in the recruitment or follow up phase. A total of 2,500 patients in over 100 trial centres have participated so far.

Citing Articles

The future of trials in surgical oncology.

Naredi P, La Quaglia M Nat Rev Clin Oncol. 2015; 12(7):425-31.

PMID: 25869462 DOI: 10.1038/nrclinonc.2015.72.

Number of published randomized controlled multi center trials testing pharmacological interventions or devices is increasing in both medical and surgical specialties.

Danielsen A, Okholm C, Pommergaard H, Burcharth J, Rosenberg J PLoS One. 2014; 9(7):e101383.

PMID: 25020129 PMC: 4096394. DOI: 10.1371/journal.pone.0101383.

Future perspectives for surgical research in Germany.

Diener M, Menger M, Jahne J, Saeger H, Klar E Langenbecks Arch Surg. 2014; 399(3):253-62.

PMID: 24615143 DOI: 10.1007/s00423-014-1178-6.

[Rotating physician in CHIR-Net. Evaluation of the curriculum].

Knoll P, Oppermann J, Vehreschild J, Beyer F, Kaulhausen T, Siewe J Chirurg. 2013; 84(12):1062-6.

PMID: 23754519 DOI: 10.1007/s00104-013-2519-7.

References

Solomon M, LAXAMANA A, DeVore L, McLeod R . Randomized controlled trials in surgery. Surgery. 1994; 115(6):707-12. View

Diener M, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt H . ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial. Trials. 2010; 11:47. PMC: 2874785. DOI: 10.1186/1745-6215-11-47. View

Hu X, Wright J, McLeod R, Lossing A, Walters B . Observational studies as alternatives to randomized clinical trials in surgical clinical research. Surgery. 1996; 119(4):473-5. DOI: 10.1016/s0039-6060(96)80150-4. View

Wente M, Seiler C, Uhl W, Buchler M . Perspectives of evidence-based surgery. Dig Surg. 2003; 20(4):263-9. DOI: 10.1159/000071183. View

Diener M, Seiler C, Rossion I, Kleeff J, Glanemann M, Butturini G . Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011; 377(9776):1514-22. DOI: 10.1016/S0140-6736(11)60237-7. View

Diener M, Seiler C, Antes G . [Systematic reviews and meta-analyses in surgery]. Chirurg. 2007; 78(10):938-44. DOI: 10.1007/s00104-007-1404-7. View

Diener M, Voss S, Jensen K, Buchler M, Seiler C . Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg. 2010; 251(5):843-56. DOI: 10.1097/SLA.0b013e3181d973e4. View

Fink C, Keck T, Rossion I, Weitz J, Diener M, Buchler M . [Contribution of the Study Center of the German Surgical Society to evidence based surgery]. Chirurg. 2011; 82(12):1109-15. DOI: 10.1007/s00104-011-2121-9. View

Rahbari N, Aigner M, Thorlund K, Mollberg N, Motschall E, Jensen K . Meta-analysis shows that detection of circulating tumor cells indicates poor prognosis in patients with colorectal cancer. Gastroenterology. 2010; 138(5):1714-26. DOI: 10.1053/j.gastro.2010.01.008. View

10.

Buchler M, Diener M, Weitz J . Scientific evaluation of modern clinical research: we need a new currency!. Langenbecks Arch Surg. 2011; 396(7):937-9. DOI: 10.1007/s00423-011-0842-3. View

11.

Seiler C, Bruckner T, Diener M, Papyan A, Golcher H, Seidlmayer C . Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg. 2009; 249(4):576-82. DOI: 10.1097/SLA.0b013e31819ec6c8. View

12.

Loffler T, Seiler C, Rossion I, Kijak T, Thomusch O, Hodina R . Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial. Trials. 2011; 12:34. PMC: 3042950. DOI: 10.1186/1745-6215-12-34. View

13.

Rahbari N, Koch M, Mehrabi A, Weidmann K, Motschall E, Kahlert C . Portal triad clamping versus vascular exclusion for vascular control during hepatic resection: a systematic review and meta-analysis. J Gastrointest Surg. 2008; 13(3):558-68. DOI: 10.1007/s11605-008-0588-6. View

14.

Gluud C, Nikolova D . Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. Trials. 2007; 8:7. PMC: 1808475. DOI: 10.1186/1745-6215-8-7. View

15.

Howes N, Chagla L, Thorpe M, McCulloch P . Surgical practice is evidence based. Br J Surg. 1997; 84(9):1220-3. View

16.

Boutron I, Moher D, Altman D, Schulz K, Ravaud P . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008; 148(4):295-309. DOI: 10.7326/0003-4819-148-4-200802190-00008. View

17.

Seiler C, Frohlich B, Veit J, Gazyakan E, Wente M, Wollermann C . Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery. Trials. 2006; 7:27. PMC: 1586210. DOI: 10.1186/1745-6215-7-27. View

18.

Rahbari N, Diener M, Fischer L, Wente M, Kienle P, Buchler M . A concept for trial institutions focussing on randomised controlled trials in surgery. Trials. 2008; 9:3. PMC: 2259294. DOI: 10.1186/1745-6215-9-3. View

19.

Fitzmaurice C, Seiler C, Buchler M, Diener M . [Survival, mortality and quality of life after pylorus-preserving or classical Whipple operation. A systematic review with meta-analysis]. Chirurg. 2009; 81(5):454-71. DOI: 10.1007/s00104-009-1829-2. View

20.

Diener M, Wolff R, von Elm E, Rahbari N, Mavergames C, Knaebel H . Can decision making in general surgery be based on evidence? An empirical study of Cochrane Reviews. Surgery. 2009; 146(3):444-61. DOI: 10.1016/j.surg.2009.02.016. View