Kort-SGS: Does a series of intralesional steroid injections after endoscopic treatments for subglottic stenosis prolong interval between between surgical interbentions? A prospective single blinded randomised study - kort-SGS

Region Örebro Län0 个研究点目标入组 20 人开始时间: 2018年4月5日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1.= 18 - = 70 years old with subglottic stenosis ( ICD diagnose code J38.6, J38.7, J39.8, J95.5, J95.8) that will be treated surgically.
•2.Able and willing to leave a written consent.
•3.Able and willing to comply with
•protocol procedures.
•4. Have a symtomatic subglottic stenosis
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1.Stenosis caused by a malignant tumor, external preassure on the trachea (eg enlarged thyroid), post radiation effect in the mucous membrande and glotttic or supraglottic involvement.
•2. Stenosis that does not respond to endoscopic surgery: deformed cartilage, either in cricoid cartilage and/or trachea. These types of subglottic stenosis are successfully treated with open surgery.
•3. Women who are pregnant or nursing when surgery is schedule and during ongoing treatment with steroid injections. In case of uncertainty a pregnancy test is done. Women of childbearing potential not using contraception.
•4. Individuals with confirmed or suspected cognitive failure caused by acute or chronical conditions, such as neuro psychiatric illness (eg dementia, retardation etc), patients under intensive care with lowered conciousness.

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