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.
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References
http://www.destatis.de/jetspeed/portal/cms/Sites/destatis/Internet/DE/Content/Publikationen/Fachveroeffentlichungen/Gesundheit/Krankenhaeuser/OperationenProzeduren5231401107014,property=file.pdf; Fallpauschalenbezogene Krankenhausstatistik (DRG-Statistik). Operationen und Prozeduren der vollstationären Patientinnen und Patienten in Krankenhäusern—Ausführliche Darstellung—2010; Statistisches Bundesamt, Wiesbaden 2011
Gluud C, Nikolova D (2007) Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. Trials 8:7
Wente MN, Seiler CM, Uhl W, Buechler MW (2003) Perspectives of evidence-based surgery. Dig Surg 20:263–269
Howes N, Chagla L, Thorpe M, McCulloch P (1997) Surgical practice is evidence based. Br J Surg 84:1220–1223
Solomon MJ, Laxamana A, Devore L, McLeod RS (1994) Randomized controlled trials in surgery. Surgery 115:707–712
Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, the Balliol Collaboration (2009) Challenges in evaluating surgical innovation. Lancet 374(9695):1097–1104
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 148(4):295–309
Hu X, Wright JG, McLeod RS et al (1996) Observational studies as alternatives to randomized clinical trials in surgical clinical research. Surgery 119:473–475
Fink C, Keck T, Rossion I, Weitz J, Diener MK, Büchler MW, Knebel P (2011) Contribution of the Study Center of the German Surgical Society to evidence based surgery. Chirurg 82(12):1109–1115
Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel HP (2009) Interrupted or continuously slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg 249:576–582
Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Burns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Keser M, Büchler MW (2011) Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet 377:1514–1522
Seiler CM, Frohlich BE, Veit JA, Gazyakan E, Wente MN, Wollermann C, Deckert A, Witte S, Victor N, Büchler MW, Knaebel HP (2006) Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery. Trials 7:27
Schlosser K, Veit JA, Witte S, Fernandes ED, Victor N, Knaebel HP, Seiler CM, Rothmund M (2007) Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplant and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial. Trials 8:22
Löffler T, Seiler CM, Rossion I, Kijak T, Thomusch O, Hodina R, Kruger M, Simon T, Bruckner T, Kieser M, Büchler MW, Weitz J (2011) Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial. Trials 12:34
Heger U, Voss S, Knebel P, Doerr-Harim C, Neudecker J, Schuhmacher C, Faist E, Diener MK, Kieser M, Seiler CM, Büchler MW (2011) Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial. Trials 12:245
Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM (2010) ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial. Trials 11:47
Knaebel HP, Diener MK, Wente MN, Büchler MW, Seiler CM (2005) Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg 92(5):539–546
Diener MK, Simon T, Büchler MW, Seiler CM (2011) Surgical evaluation and knowledge transfer-methods of clinical research in surgery. Langenbecks Arch Surg [Epub ahead of print]
Diener MK, Seiler CM, Antes G (2007) Systematic reviews and meta-analyses in surgery. Chirurg 78:938–944
Büchler MW, Diener MK, Weitz J (2011) Scientific evaluation of modern clinical research: we need a new currency! Langenbecks Arch Surg 396(7):937–939
Diener MK, Wolff RF, von Elm E, Rahbari NN, Mavergames C, Knaebel HP, Seiler CM, Antes G (2009) Can decision making in general surgery be based on evidence? An empirical study of Cochrane Reviews. Surgery 146:444–461
Diener MK, Voss S, Jensen K, Büchler MW, Seiler CM (2010) Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg 251:843–856
Rahbari NN, Aigner M, Thorlund K, Mollberg N, Motschall E, Jensen K, Diener MK, Büchler MW, Koch M, Weitz J (2010) Meta analysis shows that detection of circulating tumor calls indicates poor prognosis in patients with colorectal cancer. Gastroenterology 138:1714–1726
Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Büchler MW (2007) Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meat-analysis. Am J Surg 193:171–183
Rhabari NN, Koch M, Mehrabi A, Weidmann K, Motschall E, Kahlert C, Büchler MW, Weitz J (2009) Portal triad clamping vs. vascular exclusion for vascular control during hepatic resection: a systematic review and meta-analysis. J Gastrointest Surg 13:558–568
Diener MK, Firzmaurice C, Schwarzer G, Seiler CM, Antes G, Knaebel HP, Büchler MW (2011) Pylorus-preserving pancreaticoduodenectomy (pp Whipple) vs. pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma. Cochrane Database Syst Rev CD006053
Diener MK, Tadjalli-Mehr K, Wente MN, Kieser M, Büchler MW, Seiler CM (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(1):41–52
Knaebel HP, Diener MK, Wente MN, Büchler MW, Seiler CM (2005) Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg 92:539–546
Rahbari NN, Wente MN, Schemmer P, Diener MK, Hoffmann K, Motschall E, Schmidt J, Weitz J, Büchler MW (2008) Systematic review and meta-analysis of the effect of portal triad clamping on outcome after hepatic resection. Br J Surg 95:424–432
Michalski CW, Kleeff J, Wente MN, Diener MK, Büchler MW, Firess H (2007) Systematic review and meta-analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer. Br J Surg 94:265–273
Fitzmaurice C, Seiler CM, Büchler MW, Diener MK (2010) Survival, mortality and quality of life after pylorus-preserving or classical Whipple operation. A systematic review with meta-analysis. Chirurg 81:454–471
Rahbari NN, Diener MK, Fischer L, Wente MN, Kienle P, Büchler MW, Seiler CM (2008) A concept for trial institutions focussing on randomised controlled trials in surgery. Trials 9:3
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Phillip Knebel and Shafreena Kühn contributed equally.
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Knebel, P., Kühn, S., Ulrich, A.B. et al. The Study Centre of the German Surgical Society: current trials and results. Langenbecks Arch Surg 397, 611–618 (2012). https://doi.org/10.1007/s00423-012-0922-z
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DOI: https://doi.org/10.1007/s00423-012-0922-z