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

Официальное название

Evaluating The Efficacy of Platelet Rich Plasma on Voice Outcomes Following Surgical Removal of Benign Vocal Fold Lesions

Обзор

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.

Подробное описание

Benign vocal fold lesions are commonly treated with microlaryngosurgery when conservative management fails; however, postoperative voice recovery may be variable, and some patients experience persistent dysphonia or vocal fatigue. Platelet-rich plasma (PRP) has been proposed as a biologic adjunct that may enhance tissue healing through its regenerative and anti-inflammatory properties.

This clinical trial evaluates the effect of postoperative PRP injection as an adjunct to microlaryngosurgery for benign vocal fold lesions. The study compares voice recovery in patients receiving PRP injection during surgery with those receiving conventional postoperative management alone.

Adult patients undergoing microlaryngosurgery for benign vocal fold lesions will be enrolled and allocated to one of two study groups: a PRP injection group or a conventional treatment group. All participants will undergo standard surgical management, with the intervention group receiving an additional PRP injection to the operated vocal fold.

Voice outcomes will be assessed longitudinally at predefined postoperative intervals using objective, perceptual, and patient-reported measures. These assessments are intended to evaluate postoperative voice quality, vocal function, and patient-perceived vocal fatigue.

All participants will undergo routine preoperative evaluation and provide written informed consent in accordance with institutional and ethical guidelines.

This study aims to determine whether PRP injection provides additional benefit in voice recovery following microlaryngosurgery for benign vocal fold lesions.

Вмешательства

• Процедура Platelet-Rich Plasma (PRP) Injection after Microlaryngoscopic Surgery for PRP Group
  Platelet-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 scarrin
• Процедура Conventional Microlaryngoscopic Surgery (Active Comparator)
  Patients 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.

Первичные конечные точки

• Shimmer (Local, dB) [Срок оценки: From enrollment, including baseline voice assessment, through surgery and postoperative follow-up assessments at 1 month and 3 months]

Вторичные конечные точки (1)

• Harmonic to noise Ratio [Срок оценки: Baseline (preoperative), 1 month postoperative, and 3 months postoperative]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Beni Suef Univesity hospital — Banī Suwayf

Идентификаторы

NCT: NCT07300800 · FMBSUREC/04032025/Mohammed

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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