Effect of PRP Injection on Voice Recovery After Benign Vocal Fold Surgery
ConditionBenign Vocal Fold Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Age younger than 18 years or above 50
Medically unfit for surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group
Procedure/SurgeryPlatelet-Rich Plasma (PRP) Injection Patients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia. Following surgery, autologous PRP will be injected into the superficial lamina propria (Reinke's space), just lateral to the excision site, using a Chiba needle. The injection aims to promote tissue regeneration, improve postoperative healing, and enhance vocal quality. Care is taken to avoid the free edge of the vocal fold to minimize scarring or stiffness. The PRP is prepared fresh from the patient's blood on the day of injection.
Conventional Microlaryngoscopic Surgery (Active Comparator)
Procedure/SurgeryPatients in this group will undergo microlaryngoscopic removal of benign vocal fold lesions under general anesthesia without PRP injection. Standard postoperative care is provided. This group serves as a comparator to evaluate the additional effect of PRP on voice recovery.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: PRP GroupExperimental treatment 1 intervention
Group B: Conventional Surgery GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Shimmer (Local, dB)
Shimmer (local), expressed in decibels (dB), representing cycle-to-cycle amplitude variation, will be obtained from sustained vowel /a/ using PRAAT software.
Time frame
From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 monthsSecondary outcomes
1
Harmonic to noise Ratio
Harmonic to Noise Ratio, will be obtained from sustained vowel /a/ using PRAAT software. Unit of Measure: dB
Time frame
Baseline (preoperative), 1 month postoperative, and 3 months postoperativeSponsors and contacts
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Source ClinicalTrials.gov