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Title: Reporting of adverse events in surgical trials: critical appraisal of current practice

Journal: World Journal of surgery

Authors: Rachel Rosenthal, MD, MSc, Henry Hoffmann, MD, Kerry Dwan, PhD, Pierre-Alain Clavien, MD, PhD, Heiner C. Bucher, MD, MPH

Corresponding author: Rachel Rosenthal, Department of Surgery, University Hospital Basel, Spitalstrasse 26, CH-4031 Basel, Switzerland, Phone: +41 61 556 53 63, Fax: +41 61 265 88 81, Email:

Online-Only References (References of the studies included in the analysis)

* references of the studies included in the analysis (other references in the manuscript are presented without *)

add additional publications concerning a specific RCT

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37* Jiang ZM, Wilmore DW, Wang XR, et al. Randomizedclinicaltrial of intravenoussoybeanoilaloneversussoybeanoilplusfishoilemulsionaftergastrointestinalcancersurgery. Br J Surg 2010; 97(6):804-809.

38* Shepherd AC, Gohel MS, Brown LC, et al. Randomized clinical trial of VNUSClosureFASTradiofrequencyablationversuslaser for varicose veins. Br J Surg 2010; 97(6):810-818.

39* Steffen T, Warschkow R, Brändle M, et al. Randomizedcontrolledtrial of bilateralsuperficialcervicalplexusblockversusplacebo in thyroidsurgery. Br J Surg2010; 97(7):1000-1006.

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41* Carli F, Charlebois P, Stein B, et al. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg2010; 97(8):1187-1197.

42* Hendry PO, van Dam RM, Bukkems SF, et al.; EnhancedRecoveryAfterSurgery (ERAS) Group. Randomizedclinicaltrial of laxatives and oralnutritionalsupplements within an enhancedrecoveryaftersurgeryprotocolfollowingliverresection.Br J Surg2010; 97(8):1198-1206.

43* Maeda Y, Ng SC, Durdey P, et al.; Topical Metronidazole in PerianalCrohn's Study Group.Randomizedclinicaltrial of metronidazoleointmentversusplacebo in perianalCrohn'sdisease.Br J Surg2010; 97(9):1340-1347.

44* Bevis PM, Windhaber RA, Lear PA, et al. Randomizedclinicaltrial of meshversussuturedwoundclosureafteropenabdominalaorticaneurysmsurgery. Br J Surg 2010;97(10):1497-1502.

45* Momsen AH, Jensen MB, Norager CB, et al. Randomizeddouble-blindplacebo-controlledcrossoverstudy of caffeine in patients with intermittentclaudication’ Br J Surg 2010; 97(10):1503-1510.

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47* Nthumba PM, Stepita-Poenaru E, Poenaru D, et al. Cluster-randomized, crossovertrial of the efficacy of plainsoap and waterversusalcohol-basedrub for surgicalhandpreparation in a ruralhospital in Kenya.Br J Surg 2010; 97(11):1621-1628.

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49* Jayne DG, Thorpe HC, Copeland J, et al. Five-yearfollow-up of the MedicalResearchCouncilCLASICCtrial of laparoscopicallyassistedversusopensurgery for colorectalcancer. Br J Surg 2010; 97(11):1638-1645.

49*add1Guillou P, Quirke P, Thorpe H, et al.; MRCCLASICCtrialgroup. Short-termendpoints of conventionalversus laparoscopic-assisted surgery in patients with colorectalcancer (MRCCLASICCtrial): multicentre,randomisedcontrolledtrial. Lancet 2005; 365(9472):1718-1726.

49*add2 Jayne DG, Guillou PJ, Thorpe H, et al.; UKMRCCLASICCTrialGroup. Randomizedtrial of laparoscopic-assistedresection of colorectalcarcinoma: 3-yearresults of the UKMRCCLASICCTrialGroup. J ClinOncol 2007; 25(21):3061-3068.

50* Chalmers RT, Darling III RC, Wingard JT, et al. Randomized clinical trial of tranexamicacid-freefibrin sealant during vascular surgical procedures. Br J Surg 2010; 97(12):1784-1789.

51* Watanabe M, Murakami M, Nakao K, et al. Randomizedclinicaltrial of the influence of mechanicalbowelpreparation on faecalmicroflora in patientsundergoingcoloniccancerresection. Br J Surg 2010; 97(12):1791-1797.