Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT02672904
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.
Study:
NCT02672904
Study Brief:
Protocol Section:
NCT02672904