Clinical trial · Interventional
Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma
Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer. Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
| Voice Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyaluronic acid | Drug | — | UNRESOLVED |
| No Hyaluronic Acid Injection Injection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group - Receiving Hyaluronic Acid Injection
- description
- Randomized group of patients receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
- interventionNames
- Drug: Hyaluronic acid
- type
- PLACEBO_COMPARATOR
- label
- Control Group - Not Receiving Hyaluronic Acid Injection
- description
- Randomized group of patients not receiving hyaluronic acid injection into the glottis during transoral laser microsurgery for early glottic cancer.
- interventionNames
- Other: No Hyaluronic Acid Injection Injection
Primary outcomes (6)
- measure
- Voice Outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females * 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC * Lesion amenable to CO2 TLM resection. Exclusion Criteria: * Previous radiotherapy to the head and neck. * Palpable, or radiographic, pathological lymphadenopathy. * Allergy, or sensitivity, to HA or components of the injectable. * Neurological disorder affecting phonation, such as multiple sclerosis or stroke.
References
Publications (0)
Data not yet available