Chapter 29. General Surgery

  1. David Machin3,4,5,
  2. Simon Day6 and
  3. Sylvan Green7
  1. Dr Olga Jonasson1,† and
  2. Domenic Reda2

Published Online: 17 MAY 2007

DOI: 10.1002/9780470010167.ch29

Textbook of Clinical Trials, Second Edition

Textbook of Clinical Trials, Second Edition

How to Cite

Jonasson, O. and Reda, D. (2006) General Surgery, in Textbook of Clinical Trials, Second Edition (eds D. Machin, S. Day and S. Green), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470010167.ch29

Editor Information

  1. 3

    Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre Singapore, 11 Hospital Drive, Singapore 16910, Singapore

  2. 4

    UK Children's Cancer Study Group, University of Leicester, UK

  3. 5

    Medical Statistics Group, School of Health and Related Sciences, University of Sheffield, UK

  4. 6

    Licensing Division, Medicines and Healthcare products Regulatory Agency, Room 13–205 Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK

  5. 7

    Arizona Cancer Centre, Tucson, Arizona, USA

Author Information

  1. 1

    University of Illinois College of Medicine, Chicago, USA

  2. 2

    Department of Veterans Affairs Cooperative Studies Program Coordinating Center (151K), Hines VA Hospital, PO Box 5000-151K, Hines, IL 60141, USA

  1. Dr Olga Jonasson died in August 2006 whilst this book was in production.

Publication History

  1. Published Online: 17 MAY 2007
  2. Published Print: 24 NOV 2006

ISBN Information

Print ISBN: 9780470010143

Online ISBN: 9780470010167



  • general surgery;
  • laparoscopic cholecystectomy;
  • clinical trial barriers in surgery;
  • Data and Safety Monitoring Board (DSMB) in surgical clinical trials;
  • quality adjusted life years (QALY)


This chapter contains sections titled:

  • Background

  • Why Perform Clinical Trials in Surgery?

  • When should a Clinical Trial in Surgery be Considered?

  • Forces Opposing Clinical Trials in Surgery

  • Barriers to Clinical Trials in Surgery

  • The Unique Nature of Surgical Trials

  • Recruitment of Subjects

  • Why Randomise?

  • Precision

  • Outcome Measures

  • The Role of a DSMB in a Surgical Clinical Trial

  • Publication and Registration of Surgical Clinical Trials

  • Conclusion

  • References