European Archives of Oto-Rhino-Laryngology

, Volume 270, Issue 9, pp 2551–2557 | Cite as

Consenting for risk in common ENT operations: an evidence-based approach

  • M. E. SmithEmail author
  • R. Lakhani
  • N. Bhat


Pre-operative consent discussion and documentation is an essential process that should follow relevant guidance, and include all serious or frequently occurring risks. We assessed the appropriateness of consent for grommet insertion, tonsillectomy, septoplasty, and hemithyroidectomy, by comparing the risks listed in current consenting practice to published complication data for the relevant operation. 120 consent forms and associated clinic letters were analysed. A literature search identified published complication data for comparison. There was great variation in consent practice for each operation type, and poor correlation with published risk incidence. Only ‘bleeding’ post-tonsillectomy and ‘recurrent laryngeal nerve injury’ post hemithyroidectomy were listed in 100 % of relevant cases. Common and serious complications were frequently omitted from forms. The number and type of risks consented for a procedure significantly differed between consultant and non-consultant staff. The potential requirement for blood transfusion was discussed in only 20 % of tonsillectomy cases. Currently, the pre-operative consent for commonly performed ENT operations does not reflect operative risks. Consenting for surgical complications should be evidence based using published or personal data. A change in the consent process is required to protect patient autonomy and meet both legal and professional body requirements.


Informed consent Consent forms Tonsillectomy Thyroidectomy Middle ear ventilation Nasal septum 


Conflict of interest



  1. 1.
    Department of Health (2009) Reference guide to consent for examination or treatment, 2nd edn. Department of Health, LondonGoogle Scholar
  2. 2.
    The Royal College of Surgeons of England Good surgical practice (2008) The Royal College of Surgeons of England, LondonGoogle Scholar
  3. 3.
    General Medical Council Consent: patients and doctors making decisions together (2008) General Medical Council, LondonGoogle Scholar
  4. 4.
    Jeyaseelan L, Ward J, Papanna M, Sundararajan S (2010) Quality of consent form completion in orthopaedics: are we just going through the motions? J Med Ethics 36:407–408PubMedCrossRefGoogle Scholar
  5. 5.
    Pearce ((1999) 48 BMLR 118) v United Bristol Healthcare NHS TrustGoogle Scholar
  6. 6.
    deVries H et al (2009) International comparison of ten medical regulatory systems. RAND Corporation, Santa MonicaGoogle Scholar
  7. 7.
  8. 8.
    Professional code for physicians in germany. Accessed 14 Mar 2013
  9. 9.
    ENT-UK (2006) Clinical audit and practice advisory group. version of NICE Guidelines for pre-operative tests. ENT-UK, LondonGoogle Scholar
  10. 10.
    Kay DJ, Nelson M, Rosenfeld RM (2001) Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg 124:374–380PubMedCrossRefGoogle Scholar
  11. 11.
    Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ (2010) Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane database of systematic reviews (online) doi: 10.1002/14651858.CD001801.pub3
  12. 12.
    National prospective tonsillectomy audit final report (2005) The Royal College of Surgeons of England, LondonGoogle Scholar
  13. 13.
    Pinder DK, Wilson H, Hilton MP (2011) Dissection versus diathermy for tonsillectomy. Cochrane Database Syst Rev 16:CD002211Google Scholar
  14. 14.
    Evans AS, El-Hawrani A, Lodhi A, Thompson A (2003) Lip injury prevention during tonsillectomy. J Laryngol Otol 117:549–550PubMedCrossRefGoogle Scholar
  15. 15.
    Bak NB (2010) Accidental tooth avulsion during tonsillectomy. Ugeskr Laeger 24:1611–1612Google Scholar
  16. 16.
    Heiser C, Landis BN, Giger R, Van Cao H, Guinand N, Hörmann K, Stuck BA (2010) Taste disturbance following tonsillectomy—a prospective study. Laryngoscope 120:2119–2124PubMedCrossRefGoogle Scholar
  17. 17.
    Dhiwakar M, Clement WA, Supriya M, McKerrow W (2010) Antibiotics to reduce post-tonsillectomy morbidity. Cochrane Database Syst Rev 7:CD005607PubMedGoogle Scholar
  18. 18.
    Randall DA, Hoffer ME (1998) Complications of tonsillectomy and adenoidectomy. Otolaryngol Head Neck Surg 118:61–68PubMedCrossRefGoogle Scholar
  19. 19.
    Bateman ND, Woolford TJ (2003) Informed consent for septal surgery: the evidence-base. J laryngol otol 117:186–189. doi: 10.1258/002221503321192476 PubMedGoogle Scholar
  20. 20.
    Vaiman M, Sarfaty S, Shlamkovich N, Segal S, Eviatar E (2005) Fibrin sealant: alternative to nasal packing in endonasal operations a prospective randomized study. Isr Med Assoc J 7:571–574PubMedGoogle Scholar
  21. 21.
    The British Association of Endocrine and Thyroid Surgeons. Third National Audit Report (2009) BAETS, London. ISBN 1- 903968-25-9Google Scholar
  22. 22.
    Wj C (2010) Fifteen years’ experience in thyroid surgery. Ann R Coll Surg Engl 92:541–547CrossRefGoogle Scholar
  23. 23.
    Keulers BJ et al (2008) Surgeons underestimate their patients’ desire for preoperative information. World J Surg 32:964–970PubMedCrossRefGoogle Scholar
  24. 24.
    McManus PL, Wheatley KE (2003) Consent and complications: risk disclosure varies widely between individual surgeons. Ann R Coll Surg Engl 85:79–82PubMedCrossRefGoogle Scholar
  25. 25.
    Beresford-Cleary NJ, Halliday J, Breusch SJ, Biant LC (2011) Consent process for elective total hip and knee arthroplasty. J orthop surg (Hong Kong) 19:274–278Google Scholar
  26. 26.
    Murphy K, Shafiq A, Corrigan MA, Redmond HP (2011) A descriptive study of consent documentation. Ir Med J 104:238–240PubMedGoogle Scholar
  27. 27.
    British Medical Association (2009) Consent tool kit, 5th edn. British Medical Association, LondonGoogle Scholar
  28. 28.
    Chadha NK, Pratap R, Narula AA (2003) Consent processes in common nose and throat procedures. J Laryngol Otol 117:536–539PubMedCrossRefGoogle Scholar
  29. 29.
    McDonald SE, Chadha NK, Mills RS (2008) Changing practices in the consent process for nose and throat procedures: a three-year study. J Laryngol Otol 122:1–4CrossRefGoogle Scholar
  30. 30.
    Puwanarajah P, McDonald SE (2010) Changes in surgical consent practices for common otolaryngology procedures: impact of modernising medical careers. J Laryngol Otol 124:899–904PubMedCrossRefGoogle Scholar
  31. 31.
    Mistry D, Kelly G (2004) Consent for tonsillectomy. Clin Otolaryngol Allied Sci 29:362–368PubMedCrossRefGoogle Scholar
  32. 32.
    Chester V, Afshar (2002). EWCA Civ 724; [2003] QB 356Google Scholar
  33. 33.
  34. 34.
    Molinelli A, Bonsignore A, Rocca G, Ciliberti R (2009) Medical treatment and patient decisional power: the Italian state of the art. Minerva Med 100:429–434PubMedGoogle Scholar
  35. 35.
    The charter of fundamental rights of the european union. http://wwweuroparleuropaeu/charter/default_enhtm. Accessed 14 Mar 2013
  36. 36.
    Simonsen AR, Duncavage JA, Becker SS (2010) A review of malpractice cases after tonsillectomy and adenoidectomy. Int J Pediatr Otorhinolaryngol 74:977–979PubMedCrossRefGoogle Scholar
  37. 37.
    Stevenson AN, Myer CM 3rd, Shuler MD, Singer PS (2012) Complications and legal outcomes of tonsillectomy malpractice claims. Laryngoscope 122:71–74. doi: 10.1002/lary.22438 PubMedCrossRefGoogle Scholar
  38. 38.
    Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A (1993) Factors affecting quality of informed consent. BMJ 306:885–890PubMedCrossRefGoogle Scholar
  39. 39.
    Mahadevan D, Gupta S (2009) Consent for orthopaedic surgery: patient comprehension. Clin Gov 14:20e23Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Department of Ear, Nose and Throat SurgeryPeterborough and Stamford Hospitals NHS Foundation TrustPeterboroughUK

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