Laryngeal Neoplasms
Conditions
Keywords
vocal cord, carcinoma, ktp laser, co2 laser, endoscopic surgery
Brief summary
comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser
Detailed description
Randomized controlled double-blinded study. The study group includes patients diagnosed with early glottic cancer, either carcinoma in situ or T1a-b,N0M0 squamous cell carcinoma. Patients will undergo examination and treatment and at least 3 years of follow-up. 40 cancer patients will be included. The participants will be randomly divided into two groups: the first will be treated by KTP laser and the second by CO2 laser. The patients will be blinded to the method of treatment. To enable double-blinding, the investigator performing the surgery would be the only one knowing which research group the patient belongs to. The investigator in charge of collecting the data after the operation will be blinded to the treatment method. Each participant will undergo pre-operative evaluation and follow-up after surgery in both arms. Preoperative evaluation will include: * Voice Handicap Index questionnaire * GRBAS - subjective assessment of voice quality. * Video-stroboscopy of vocal cords * Voice Analysis . Follow-up after surgery: * Visit 6 weeks after surgery (± two weeks), and then every three months (± 6 weeks). * repeated full evaluation (questionnaire, GRBAS, Stroboscopy, voice analysis) in 30 weeks of follow up and 3 years of follow up.
Interventions
DEVICECO2 laser
surgical removal of carcinoma from the vocal cords with CO2 laser
DEVICEKTP laser
surgical removal of carcinoma from the vocal cords with KTP laser
Sponsors
Kaplan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( Carcinoma in situ or T1-glottic carcinoma).
Exclusion criteria
* Patients who underwent previous significant vocal cords surgical intervention , or irradiation. * Contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| voice quality results In the long term | 3 years after last intervention | objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire |
| Duration of surgery | intraoperative | total time (minutes) of surgical procedure |
| number of surgical interventions | 3 years | total number of surgical interventions needed to eliminate the disease |
| Recovery time after surgery | up to 3 years | recovery in terms of overall function, breathing, swallowing and vocal communication |
| voice quality results In the short term | 6 month after last intervention | objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire |
| Cure rates in terms of local, regional or distant recurrence events | 3 years after last intervention | evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases |
| Overall survival and disease-dependent survival over a period of at least 3 years | 3 years after last intervention | — |
Countries
Israel
Contacts
Primary ContactYonatan Lahav, Dr
Backup ContactYaara Haimovich
Outcome results
None listed