What are the key considerations for informed consent prior to undergoing injection laryngoplasty?

Key Considerations for Informed Consent Prior to Injection Laryngoplasty

Patients undergoing injection laryngoplasty require comprehensive informed consent that includes explanation of the procedure, risks, benefits, alternatives, and potential complications to ensure they can make an informed decision about their care.

Essential Components of Injection Laryngoplasty Consent

• The consent process should include a detailed explanation of what the injection laryngoplasty procedure entails and why it is being recommended, including the surgical approach and recovery process 1
• Discussion should cover the setting of the procedure (office vs. operating room), as this choice does not significantly impact voice outcomes but may affect patient comfort and preferences 2
• The urgency level and timing considerations should be explained, particularly when the procedure is being performed for potentially recoverable vocal fold paralysis as a temporary intervention 3
• Documentation of the patient's agreement to the procedure, including record of specific discussions and any concerns, is essential for ensuring informed consent 4

Procedure-Specific Information

• Explain the goal of the procedure: medialization of the abnormally positioned vocal fold to optimize phonatory closure 5
• Discuss the type of injectable material to be used (e.g., calcium hydroxylapatite, hyaluronic acid derivatives, autologous fascia) and its expected longevity in the larynx 6
• Clarify whether the procedure is intended as a temporary intervention while awaiting spontaneous recovery or as a more definitive treatment 3
• Explain the technical approach (percutaneous, transoral, or direct laryngoscopy) and type of anesthesia to be used 5

Risks and Complications

• Common side effects include pain, discomfort, temporary voice changes, and potential for aspiration 1
• Procedure-specific risks include under-correction (insufficient medialization), over-correction (excessive medialization causing airway obstruction), material migration, granuloma formation, and infection 6, 7
• Serious complications, although rare, must be discussed to ensure fully informed consent 4
• Patient-specific risks must be identified and discussed, such as professional voice users who may have specific concerns about voice quality outcomes 4

Anesthesia-Specific Information

• Discuss options available for anesthesia, including local anesthesia for office-based procedures versus general anesthesia for operating room procedures 2
• Explain risks specific to the chosen anesthesia approach, such as discomfort during the procedure with local anesthesia or risks associated with general anesthesia 4
• Alternative anesthetic techniques should be explained if the primary approach fails 4

Expected Outcomes and Alternatives

• Discuss expected voice outcomes, including the likelihood of improvement in vocal quality and function 2, 3
• For patients with potentially recoverable vocal fold paralysis, explain the possibility of spontaneous recovery (24% full recovery, 10% partial recovery with adequate voice in one study) 3
• Present alternative treatment options, including voice therapy, framework surgery (thyroplasty), and observation 6, 3
• Explain that injection laryngoplasty has limitations in addressing posterior glottic insufficiency, which may require framework surgery in some cases 6

Special Considerations

• Consider language barriers and arrange for professional interpreters rather than family members when needed 1
• Allow patients time to ask questions and provide honest answers as part of an effective dialogue 4
• For procedures performed by trainees or students, specific consent may be required if there are additional risks from inexperienced use 4
• When the procedure is the primary therapeutic intervention rather than an adjunct to another treatment, a formal signed consent form may be more appropriate 4

Documentation Requirements

• Document discussions that led to the agreement, including the patient's questions and the responses given 4
• Record specific discussions about risks, benefits, and alternatives, particularly for patient-specific concerns 4
• If the patient wishes to reverse a previously documented decision or goes against medical advice, ensure this is clearly documented 4