The effect of platelet rich plasma injection on voice outcomes following phonosurgery

Phase 1

Completed

• Conditions: Effect of platelet rich plasma of voice outcomes following phonosurgery for benign lesions; vocal fold polyp; platelet rich plasma; effect; outcome; phonosurgery

• Registration Number: TCTR20220205003
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-03-31
• Study Start: 2022-02-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Unilateral benign vocal fold pathology requiring phonosurgical intervention. The lesion size should not account for more than 50% of the true vocal fold length. Patients between 18-75 years of age considered eligible.

Exclusion Criteria

upper respiratory infections two weeks prior to surgery, clinical signs of malignancy or recurrent respiratory papillomatosis, uncertainty of clinical diagnosis, bilateral vocal fold pathology, prior phonosurgical intervention, voluminous unilateral lesion occupying the whole length of the vocal fold, sulcus vocalis, severe cardiovascular and pulmonary pathology after preanesthesia evaluation, patients not fit for surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
voice quality three days and 3 weeks following the procedure Two way ANOVA- comparing fundamental frequency, jitter and shimmer before and after the procedure. Measured by voice analysis softwre

Secondary Outcome Measures

Name	Time	Method
Subjectivbe voice assesmenet before the procedure and three weeks after the procedure Mean and standard deviation for each group. VHI 30 questionnaire comparing values before and three weeks after the procedure (0-no subjective voice complaint, 120 maximum score))