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Insights into surgical trials: methodological challenges and solutions

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Abstract

Background

Novel surgical methods and procedures used to be introduced by experts and were established depending on the corresponding success that was noted. Surgical trials representing evidence level 1b were and still are called into question for different reasons. Prospective randomized controlled trials comparing various surgical strategies that were conducted over the past 11 years in the clinical trial unit in the department of general, visceral, and transplantation surgery of the University of Heidelberg pointed out problems as well as possible solutions for surgical trials’ characteristics.

Purpose

When planning a study within a department of surgery, several aspects have to be considered. The article aims at outlining pitfalls that have to be dealt with as well as possible solutions by outlining experiences within several conducted trials.

Conclusions

The compilation of solutions announcing the challenges of surgical studies shows that valid high-quality trials are feasible.

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References

  1. Seiler CM, Wente MN, Diener MK, Fröhlich BE, Büchler MW, Knaebel HP (2006) Center for clinical studies in a surgical department–an approach for more evidence-based medicine. Contemp Clin Trials 27(3):211–214

    Article  PubMed  Google Scholar 

  2. Knebel P, Fröhlich B, Knaebel HP, Kienle P, Luntz S, Buchler MW, Seiler CM (2006) Comparison of Venae Sectio vs. modified Seldinger Technique for totally implantable access ports; Portas-trial [ISRCTN:52368201]. Trials 7:20

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  3. Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor H-U, Büchler MW, Seiler CM (2008) Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological Puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients. Trials 9:60. doi:10.1186/1745-6215-9-60

    Article  PubMed Central  PubMed  Google Scholar 

  4. Gehrig T, Knebel P, Scheel V, Hinz U, Seiler CM, Müller-Stich BP, Büchler MW, Gutt CN (2011) Liga Sure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial. Trials 12:162. doi:10.1186/1745-6215-12-162

    Article  PubMed Central  PubMed  Google Scholar 

  5. Hackert T, Bruckner T, Dörr-Harim C, Diener MK, Knebel P, Hartwig W, Strobel O, Fritz S, Schneider L, Werner J, Büchler MW (2013) Pylorus resection or pylorus preservation in partial pancreatico-duodenectomy (PROPP study): study protocol for a randomized controlled trial. Trials 14:44. doi:10.1186/1745-6215-14-44

    Article  PubMed Central  PubMed  Google Scholar 

  6. 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. doi:10.1186/1745-6215-11-47

    Article  PubMed Central  PubMed  Google Scholar 

  7. Rahbari NN, Lordick F, Fink C, Bork U, Stange A, Jäger D, Luntz SP, Englert S, Rossion I, Koch M, Büchler MW, Kieser M, Weitz J, SYNCHRONOUS trial group (2012) Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS–a randomised controlled multicentre trial (ISRCTN30964555). BMC Cancer 12:142. doi:10.1186/1471-2407-12-142

    Article  PubMed Central  PubMed  Google Scholar 

  8. Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns 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, Kieser M, Büchler MW (2011) Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet 377(9776):1514–1522. doi:10.1016/S0140-6736(11)60237-7

    Article  PubMed  Google Scholar 

  9. Machin D, Campbell MJ (1987) Statistical tables for the design of clinical trials Blackwell Scientific Publications (ISBN 0632012757)

  10. Parikh D, Johnson M, Chagla L, Lowe D, McCulloch P (1996) D2 gastrectomy: lessons from a prospective audit of the learning curve. Br J Surg 83(11):1595–1599

    Article  CAS  PubMed  Google Scholar 

  11. Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH (2005) Need for expertise based randomised controlled trials. BMJ 330(7482):88

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  12. Nocito A, Wildi S, Rufibach K, Clavien PA, Weber M (2009) Randomized clinical trial comparing venous cutdown with the Seldinger technique for placement of implantable venous access ports. Br J Surg 96(10):1129–1134. doi:10.1002/bjs.6730

    Article  CAS  PubMed  Google Scholar 

  13. Strobel O, Büchler MW (2013) The problem of the poor control arm in surgical randomized controlled trials. Br J Surg 100(2):172–173. doi:10.1002/bjs.8998. Epub 2012 Nov 23

    Article  CAS  PubMed  Google Scholar 

  14. Bundesministerium für Bildung und Forschung: BMBF-Förderrichtlinien Klinische Studien mit hoher Relevanz für die Patientenversorgung Leitfaden für die Antragstellung, Version 1.0 von April 2013

  15. Bruce J, Russell EM, Mollison J, Krukowski ZH (2001) The measurement and monitoring of surgical adverse events. Health Technol Assess 5:1–194

    CAS  PubMed  Google Scholar 

  16. Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M, International Study Group on Pancreatic Fistula Definition (2005) Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery 138(1):8–13

    Article  PubMed  Google Scholar 

  17. Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler MW (2007) Delayed gastricemptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 142(5):761–768

    Article  PubMed  Google Scholar 

  18. Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, DenDulk M, van de Velde C, Büchler MW (2010) Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the. Int Study Group Rectal Cancer Surg 147(3):339–351. doi:10.1016/j.surg.2009.10.012

    Google Scholar 

  19. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240(2):205–213

    Article  PubMed Central  PubMed  Google Scholar 

  20. Higgins JPT (2011) Green S (editors) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration

  21. Seiler CM, Deckert A, Diener MK, Knaebel HP, Weigand MA, Victor N, Büchler MW (2009) Midline versus transverse incision in major abdominal surgery: a randomized, double-blind equivalence trial (POVATI: ISRCTN60734227). Ann Surg 249(6):913–920. doi:10.1097/SLA.0b013e3181a77c92

    Article  PubMed  Google Scholar 

  22. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J (2009) Balliol collaboration no surgical innovation without evaluation: the IDEAL recommendations. Lancet 374(9695):1105–1112

    Article  PubMed  Google Scholar 

  23. McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK, IDEAL Group (2013) IDEAL framework for surgical innovation 1: the idea and development stages. BMJ 346:3012. doi:10.1136/bmj.f3012

    Article  Google Scholar 

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Authors and Affiliations

  1. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Markus K. Diener & Phillip Knebel

  2. Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany

    Colette Doerr-Harim & Markus K. Diener

  3. Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

    Thomas Bruckner

Authors
  1. Colette Doerr-Harim
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  2. Thomas Bruckner
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  3. Markus K. Diener
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  4. Phillip Knebel
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Correspondence to Phillip Knebel.

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Doerr-Harim, C., Bruckner, T., Diener, M.K. et al. Insights into surgical trials: methodological challenges and solutions. Langenbecks Arch Surg 399, 273–278 (2014). https://doi.org/10.1007/s00423-013-1155-5

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  • DOI: https://doi.org/10.1007/s00423-013-1155-5

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