The Pre- and Post-Operative Voice therapy trial (PaPOV)

Not Applicable

• Conditions: Pre and post-operative voice therapy for patients with benign vocal fold lesions; Ear, Nose and Throat

• Registration Number: ISRCTN17438192
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38783383/ (added 04/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-04
• Last Update Posted: 18 June 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Patients with benign vocal fold lesions (BVFLs) who have been consented for phonosurgery by an ENT surgeon as part of their management
2. Aged 18 years old and over
3. Willing and able to offer informed consent
4. Presence of unilateral or bilateral benign vocal fold lesion on the vibrating portion of the vocal fold (including one or a combination of these diagnostic categories; fibrotic vocal fold nodules, polyp, cyst, pseudocyst, polypoid fringe, Reinke's odema, sulcus, mucosal bridge, papilloma);
5. Diagnosis confirmed using videolaryngostroboscopy
6. +/- presence of additional muscle tension dysphonia/inflammation

Exclusion Criteria

1. Diagnosis of soft vocal fold nodules; these patients receive a different pathway of care
2. Diagnosis of arytenoid granuloma; this does not affect the vibratory portion of the vocal fold
3. Previous phonosurgery
4. Suspicion of malignancy requiring urgent microlaryngoscopy and biopsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility trial objectives are to gather data regarding the following parameters: <br>1. Number of eligible patients measured using the eligibility log and surgical lists at each site at the end of the study<br>2. Number of patients recruited and consented to the trial as a proportion of those eligible, measured using the eligibility log at each site at the end of the study<br>3. Number of patients completing the study as a proportion of those recruited measured using the case report form at the end of the study<br>4. The amount of clinical outcomes data completed measured using the case report form at each time point (baseline, 3 and 6 months post-surgery) (%)<br>5. The amount of health economics data completed measured using the case report form at each time point (baseline, 3 and 6 months post-surgery) (%)