RecruitingNot Applicable

Effect of PRP Injection on Voice Recovery After Benign Vocal Fold Surgery

Egypt64 participantsStarted 2025-03-04

Plain-language summary

The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections can improve voice outcomes after microlaryngosurgery in patients with benign vocal fold lesions. The main questions it aims to answer are: Does postoperative PRP injection improve vocal quality compared to conventional surgery alone? Does PRP injection reduce vocal fatigue and improve patients' voice-related quality of life? Researchers will compare 32 patients receiving PRP injections after surgical removal of lesions (intraoperative injection) to 32 patients undergoing conventional surgery without PRP to see if PRP enhances recovery and voice function. Participants will: Undergo microlaryngosurgery to remove benign vocal fold lesions. Receive a PRP injection to the operated vocal fold and standard postoperative care. Or Standard postoperative care only. Complete voice assessments before surgery and at 1 and 3 months after surgery, including: Auditory perceptual evaluation (GRBAS scale) Videostroboscopy Acoustic and aerodynamic voice analysis Vocal Fatigue Index (VFI) All participants will provide written consent and undergo standard preoperative assessments including medical history, ENT examination, laboratory tests, ECG, and anesthesia evaluation.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion Criteria: \* Adults aged 18 to 50 years \* Diagnosis of a benign vocal fold lesion, including: Vocal fold polyps Vocal fold cysts Vocal fold nodules \* Failure to respond to conservative management, including one or more of the following: Voice rest, voice therapy * Exclusion Criteria: * Age younger than 18 years or above 50 * Medically unfit for surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Shimmer (Local, dB)

Timeframe: From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 months

Trial details

NCT IDNCT07300800

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-29

Contact for this trial

Shaimaa Bakia, Lecturer

+201145335408 shaimaa.saleh@med.bsu.edu.eg

View on ClinicalTrials.gov More Benign Vocal Fold Lesions trials