Open partial horizontal laryngectomies: is it time to adopt a modular form of consent for the intervention?

SUMMARY Nowadays, open partial horizontal laryngectomies (OPHLs) are well-established procedures for treatment of laryngeal cancer. Their uniqueness is the possibility to modulate the intervention intraoperatively, according to eventual tumour extension. An OPHL procedure is not easy to understand: there are several types of procedures and the possibility to modulate the intervention can produce confusion and lack of adherence to the treatment from the patient. Even if the surgery is tailored to a patient's specific lesion, a unified consent form that discloses any possible extensions, including a total laryngectomy, is still needed. We reviewed the English literature on informed consent, and propose comprehensive Information and Consent Forms for OPHLs. The Information Form is intended to answer any possible questions about the procedure, while remaining easy to read and understand for the patient. It includes sections on laryngeal anatomy and physiology, surgical aims and indications, alternatives to surgery, complications, and physiology of the operated larynx. The Consent Form is written in a "modular" way: the surgeon defines the precise extension of the lesion, chooses the best OPHL procedure and highlights all possible expected extensions specific for the patient. Our intention, providing these forms both in Italian and in English, is to optimise communication between the patient and surgeon, improving surgical procedure arrangements and preventing any possible misunderstandings and medico-legal litigation.

[1]  E. Crosetti,et al.  Supratracheal laryngectomy: current indications and contraindications , 2015, Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale.

[2]  M. Remacle,et al.  Open partial horizontal laryngectomies: a proposal for classification by the working committee on nomenclature of the European Laryngological Society , 2014, European Archives of Oto-Rhino-Laryngology.

[3]  E. Crosetti,et al.  How the operated larynx ages , 2014, Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale.

[4]  E. Crosetti,et al.  Subtotal laryngectomy: outcomes of 469 patients and proposal of a comprehensive and simplified classification of surgical procedures , 2012, European Archives of Oto-Rhino-Laryngology.

[5]  S. Henney,et al.  Patient information in otorhinolaryngology: a prospective audit , 2011, JRSM short reports.

[6]  G. Weinstein,et al.  Aspiration after supracricoid partial laryngectomy: Incidence, risk factors, management, and outcomes , 2011, Head & neck.

[7]  E. Cunsolo Anatomy and Physiology of the operated larynx , 2010, Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale.

[8]  G. Ruoppolo,et al.  Swallowing ability and chronic aspiration after supracricoid partial laryngectomy , 2010, Otolaryngology Head & Neck Surgery.

[9]  B. Keulers,et al.  A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions , 2010, World Journal of Surgery.

[10]  A. Schindler,et al.  Supracricoid laryngectomy: Age influence on long‐term functional results , 2009, The Laryngoscope.

[11]  Huw Jenkins,et al.  Should patients set the agenda for informed consent? A prospective survey of desire for information and discussion prior to routine cataract surgery , 2008, Therapeutics and clinical risk management.

[12]  P. Appelbaum Clinical practice. Assessment of patients' competence to consent to treatment. , 2007, The New England journal of medicine.

[13]  G. Succo,et al.  Subtotal Laryngectomy With Tracheohyoidopexy: A Possible Alternative to Total Laryngectomy , 2006, The Laryngoscope.

[14]  T. Kessler,et al.  Patients' perception of preoperative information by interactive computer program-exemplified by cholecystectomy. , 2005, Patient education and counseling.

[15]  R. Albera,et al.  Informed consent in ENT. Patient's judgement about a specific consensus form. , 2005, Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale.

[16]  Michael K Paasche-Orlow,et al.  Readability standards for informed-consent forms as compared with actual readability. , 2003, The New England journal of medicine.

[17]  D. DaRosa,et al.  Residents seeking informed consent: Are they adequately knowledgeable? , 2002, Current surgery.

[18]  R. Albera,et al.  [Informed consent. Proposal of a method for ORL]. , 2000, Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale.

[19]  D. Brasnu,et al.  Neo‐adjuvant chemotherapy and supracricoid partial laryngectomy with cricohyoidopexy for advanced endolaryngeal carcinoma classified as T3–T4: 5‐year oncologic results , 1998, Head & neck.

[20]  M. de Vincentiis,et al.  Supracricoid partial laryngectomies: Oncologic and functional results , 1998, Head & neck.

[21]  J. Katz Reflections on informed consent: 40 years after its birth. , 1998, Journal of the American College of Surgeons.

[22]  R. Page,et al.  Informed consent: are we doing enough? , 1997, British journal of plastic surgery.

[23]  M. de Vincentiis,et al.  Supracricoid Laryngectomy With Cricohyoidopexy (CHP) in the Treatment of Laryngeal Cancer: A Functional and Oncologic Experience , 1996, The Laryngoscope.

[24]  D. Rothman History of informed medical consent , 1995, The Lancet.

[25]  Hjj Leenen The rights of patients in Europe. , 1994, European journal of health law.