Value of surgical pilot and feasibility study protocols

Br J Surg. 2019 Jul;106(8):968-978. doi: 10.1002/bjs.11167. Epub 2019 May 10.


Background: RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK-funded studies to explore current use of PFS in surgery and identify areas for practice improvement.

Methods: PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published.

Results: Thirty-five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date.

Conclusion: The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / organization & administration
  • Feasibility Studies*
  • Humans
  • Patient Selection
  • Pilot Projects*
  • Randomized Controlled Trials as Topic / methods
  • Research Design
  • Surgical Procedures, Operative* / methods
  • United Kingdom