comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Kapkan medical center
Rehovot, Israel
RECRUITINGDuration of surgery
total time (minutes) of surgical procedure
Time frame: intraoperative
number of surgical interventions
total number of surgical interventions needed to eliminate the disease
Time frame: 3 years
Recovery time after surgery
recovery in terms of overall function, breathing, swallowing and vocal communication
Time frame: up to 3 years
voice quality results In the short term
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
Time frame: 6 month after last intervention
voice quality results In the long term
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
Time frame: 3 years after last intervention
Cure rates in terms of local, regional or distant recurrence events
evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases
Time frame: 3 years after last intervention
Overall survival and disease-dependent survival over a period of at least 3 years
Time frame: 3 years after last intervention
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