Voice and Swallow Outcomes After Office-based Injection Laryngoplasty in Patients With Glottal Insufficiency

Not Applicable

Not yet recruiting

• Conditions: Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency
• Interventions: Drug: Hyaluronic acid

• Registration Number: NCT06161064
• Lead Sponsor: Sohag University

Brief Summary

The purpose of this study is to evaluate voice quality and swallow outcomes of office-based injection laryngoplasty using hyaluronic acid in patients with Glottal insufficiency and assess all cases after 1, 3 and 6 months.

Detailed Description

Glottic insufficiency (incompetence) is characterized by incomplete closure of the vocal folds when phonating, which causes inappropriate leakage of air through the glottis on attempting to phonate and there is an increased risk of aspiration. A wide range of laryngeal symptoms including dysphonia with or without dysphagia may result .There are varieties of causes of glottic insufficiency (GI); among the most common causes of symptomatic GI are vocal fold paralysis (complete immobility of the vocal fold), vocal fold paresis (weakness or partial immobility of the vocal fold) and presbylaryngis. Other causes of GI are sulcus vocalis, scarring or deformation of the vocal folds .Therefore, different therapy options were proposed for patients with GI based on the size of the glottic gap. Voice therapy is most suitable for patients with minimal glottic gap, regardless the reason.Injection augmentation is reserved for those with small or medium-sized glottic gap .Office-based vocal fold injection was used worldwide in early \& late Cases of GI. Office-based vocal fold injection in acute cases such as iatrogenic injury of recurrent laryngeal nerve during surgery has many advantages, these include immediate symptomatic relief, the ability to titrate degree of medialization for optimized outcomes, and monitoring of the airway.Moreover, injection in early cases prevent compensatory mechanisms as ventricular hypertrophy. Recent studies suggest that injection laryngoplasty in early cases reduce the need for permanent laryngeal framework surgery.The ideal material to be used for injection should be biocompatible and inert to decrease the risk of local tissue reaction or fibrosis. Also, the material should be easy to use and have a low cost. Furthermore, it should be durable and resistant to resorption or migration, while it maintains the normal viscoelasticity of the vocal cord after injection.

So, there are 2 types of injection materials: temporary \&permanent materials. Long-lasting injection materials(permanent) include autologous fat,calcium hydroxylapatite(CaHA) and taflon. Temporary injection materials include bovine gelatin, collagen-based products, carboxymethylcellulose and hyaluronic acid gel (HA). HA is among the most commonly used substances for injection laryngoplasty.

Actually, office-based vocal fold injection has different techniques such as percutaneous (trans-cricothyroid membrane, trans-thyroid cartilage, and trans-thyrohyoid membrane), per-oral, and trans-nasal endoscopic approaches. Typically, the three approaches are performed with a flexible laryngoscope in place, visualizing the larynx for visualization and to monitor injection effects.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study Start: 2023-12
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. The complaint of all patients is dysphonia with or without aspiration
2. Patients with small or large glottic gap
3. Patients at least 1-2 months after the onset of GI

Exclusion Criteria

Patients who are 1- >18 years old 2-Irritable 3-Exaggerated gag reflexes 4-Cardiac problems 5-Active laryngeal carcinoma 6-Patients on chemo or radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
office-based injection laryngoplasty	Hyaluronic acid	office-based injection laryngoplasty by using hyaluronic acid

Primary Outcome Measures

Name	Time	Method
voice evaluation using voice handicap index in patients with glottal insufficiency before and after injection laryngoplasty	1, 3 and 6 months	voice handicap index is a multiple questions about voice disorders patients answered before and after injection laryngoplasty

Secondary Outcome Measures

Name	Time	Method
voice evaluation using acoustics in patients with glottal insufficiency before and after injection laryngoplasty	1, 3 and 6 months	The vocal samples are obtained from the participants by holding a Microphone 10 cm in front of their mouth and producing sustained phonation. Each participant is asked to sustain the vowels /a/ /i/ /u/ followed by connected speech (counting from 1-5) using habitual and constant vocal pitch, loudness, and quality for at least 5 seconds with elimination of the irregularities in the beginning and end of utterance. The room for sampling is situated away from noise. Acoustic parameters as: Fundamental frequency, Jitter, Shimmer and noise to harmonic ratio