Informed Consent in Selected Operations in Otorhinolaryngology

Authors: M. Čerňancová 1,2;  M. Tedla 2,3
Authors‘ workplace: Otorinolaryngologické oddelenie, Univerzitná nemocnica Bratislava 1;  Klinika otorinolaryngológie a chirurgie hlavy a krku LF UK a UNB, Univerzitná nemocnica Bratislava 2;  Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, United Kingdom 3
Published in: Otorinolaryng. a Foniat. /Prague/, 66, 2017, No. 3, pp. 152-158.
Category: Case Reports


An informed consent is defined as a demonstrable consent to medical care and is an integral part of medical documentation. For surgeries it is required in writing. In the Slovak Republic an informed consent is regulated by the Act No. 576/2004 Coll., the Act on Health Care and Services related to Provision of the Health Care. At present, it is not defined what the informed consent should contain. In the thesis we propose information that should be included in the informed consent submitted to the patient at selected ENT surgeries.

Material and methodology:
In the thesis we have made an overview of literature in the database PubMed in English language using the name of the surgery and searching for the phrase informed consent in the title or in the abstract of selected surgeries in Otorhinolaryngology - tonsillectomy (TE), adenotomy (AT), functional endoscopic sinus surgery (FESS), septoplasty (SP), myringoplasty (MRP), mastoidectomy, neck dissection (KD), laryngectomy (LE), esophagoscopy, thyroidectomy. The searched articles are classified in three categories. We have studied selected articles in more detail and analyzed information presented in the informed consents.

From selected articles in which the informed consent in chosen ORL performances is discussed (tonsillectomy 113, adenotomy 9, FESS 6, septoplasty 14, myringoplasty 4, mastoidectomy 6, neck dissection 11, laryngectomy 9, esophagoscopy 3, thyroidectomy 41), we analyze complications as well as information submitted to the patient which we assess from various aspects of the relevant informed consent.

In the thesis we present the current status as published in the world related to the informed consent in ENT in terms of quantity and quality of the discussed information on surgical performance. According to available sources, we summarize and suggest the information that should be contained in the informed consent in the particular surgeries. The duly prepared informed consent will properly inform the patient and those designated by the patient to be so-informed, about the patient’s diagnosis and the options for treatment and possible complications, while at the same time it protects the doctor in a potential law suit.

informed consent, complications, otorhinolaryngology surgical performances


1. Alexander, R. J., Kukreja, R., Ford, G. R.: Secondary post-tonsillectomy haemorrhage and informed consent. J. Laryngál. Otol., 118, 2004, 12, s. 937-940.

2. Bismark, M. M., Gogos, A. J., McCombe, D., Clark, R. B., Gruen, R. L., Studdert, D. M.: Legal disputes over informed consent for cosmetic procedures: a descriptive study of negligence claims and complaints in Australia. Plast. Reconstr. Aesthet. Surg., 65, 2012, 11, s. 1506-1512.ň

3. Boszorményiová, J.: Informovaný súhlas pacienta: Kedy ho podpísať? Slovenský pacient, 2015. [Online].

4. Czarnetzki, C., Elia, N., Lysakowski, C., Dumont, L., Landis, B. N., Giger, R., Dulguerov, P., Desmeules, J., Tramèr, M. R.: Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial. JAMA, 300, 2008, 22, s. 2621-2630.

5. Dawes, P. J., O‘Keefe, L., Adcock, S.: Informed consent: the assessment of two structured interview approaches compared to the current approach. Laryngál. Otol., 106, 1992, 5, s. 420-424.

6. D‘Ascanio, L., Cappiello, L., Piazza, F.: Unilateral hemiplegia: a unique complication of septoplasty. J. Laryngál. Otol., 127, 2013, 8, s. 809-810.

7. Elinder, K., Söderman, A., Stalfors, J., Knutsson, J.: Factors influencing morbidity after paediatric tonsillectomy: a study of 18,712 patients in the National Tonsil Surgery Register in Sweden. European Archives of Oto-Rhino-Laryngology, 237, 2016, 8, s. 2249-2256.

8. Jarvis, S., Millar, J. A., Pittore, B., Safi, W.: Cerebral abscess following adenotonsillectomy: a rare complication. Acta Otorhinolaryngol Ital., 31, 2011, 4, s. 253-255.

9. Kucur, C., Ozbay, I., Oghan, F., Yildirim, N., Zeybek Sivas, Z., Canbaz, K. S.: A rare complication of radiofrequency tonsil ablation: Horner syndrome. Case Rep., Otolaryngol., 2015.

10. Nixon, I., Balaji, N., Hilmy, O., Fu, B., Brown, C. A.: Prospective study comparing conventional methods against a structured method of gaining patients‘ informed consent for tonsillectomy. Clin. Otolaryngol., 30, 2005, 5, s. 414-417.

11. Omrani, M., Barati, B., Omidifar, N., Okhovvat, A. R., Hashemi, S. A.: Coblation versus traditional tonsillectomy: A double blind randomized controlled trial. J. Res. Med. Sci., 17, 2012, 1, s. 45-50.

12 Ohtuka, K., Tomita, H., Yamauchi, Y., Kitagoh, H.: Taste disturbance after tonsillectomy. Article in Japanese, 97, 1994, 6, s. 1079-1088.

13. Pianosi, K., Gorodzinsky, A. Y., Chorney, J. M., Corsten, G., Johnson, L. B., Hong, P.: Informed consent in pediatric otolaryngology: What Risks and Benefits Do Parents Recall? 155, 2016, 2, s. 332-339.

14. Riemann, R., Demirbas, O., Milewski, C. et al..: Value of informed consent in tympanoplasty and FESS procedures. Laryngorhinootologie, 89, 2010, 3, s. 151-156.

15. Ruohoalho, J., Mäkitie, A. A., Atula, T., Takala, A., Keski-Säntti, H., Aro, K., Haapaniemi, A., Markkanen-Leppänen, M., Bäck, L. J.: Developing a registry for complications in otorhinolaryngologis surgery: Tonsil surgery as a pilot cohort.Otolaryngol. Head Neck Surg., 153, 2015, 1, s. 34-40.

16. Rakesh, S., Anand, T. S., Payal, G., Pranjal, K.: A prospective, randomized, double-blind study of coblation versus dissection tonsillectomy in adult patients. Indian Journal of Otolaryngology and Head & Neck Surgery, 64, 2012, 3, s. 290-294.

17. Zákon č. 576/2004 Z. z. Zákon o zdravotnej starostlivosti, službách súvisiacich s poskytovaním zdravotnej starostlivosti a o zmene a doplnení niektorých zákonov. Zákony pre ľudí. [Online].

18. Windfuhr, J. P.: Malpractice claims and unintentional outcome of tonsil surgery and other standard procedures in otorhinolaryngology. GMS Curr Top Otorhinolaryngol Head Neck Surg., 12, 2013.

Audiology Paediatric ENT ENT (Otorhinolaryngology)
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