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Therapy of idiopathic progressive subglottic stenosis using balloon dilation: a retrospective and prospective Study. Outcome regarding Breathing, Voice and Swallowing.

Therapy of idiopathic progressive subglottic stenosis using balloon dilation: a retrospective and prospective Study. Outcome regarding Breathing, Voice and Swallowing. - Therapy of idiopathic progressive subglottic stenosis using balloon dilation: a retrospective and prospective Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037365
Enrollment
30
Registered
2025-07-08
Start date
2025-07-12
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic progressive subglottic stenosis J38.6

Interventions

Group 1: The included patients are divided into two groups: a retrospective and a prospective cohort. Group 1: Retrospective cohort: Patients with idiopathic progressive subglottic stenosis who were t

Sponsors

Klinikum Stuttgart
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis: Idiopathic progressive subglottic stenosis (IPSS) - Ability to consent: Patients must be capable of providing informed consent independently and voluntarily. - Balloon dilation prescribed independently of the study: Only patients in whom balloon dilation was prescribed as a therapeutic measure independently of the study will be included.

Exclusion criteria

Exclusion criteria: - Previous surgeries such as cricotracheal resection (CTR), laryngotracheal reconstruction (LTR) - Long-term intubation

Design outcomes

Primary

MeasureTime frame
a. Retrospective study: - Frequency of balloon dilations over the past 10 years. - Progression of stenosis severity (based on ELS classification) between procedures. - Occurrence of complications related to balloon dilation. b. Prospective study: - Significant improvement in breathing as measured by the 6-minute walk test (difference in distance walked pre- and postoperatively) and by peak expiratory flow (PEF) values. - No significant changes in voice function (assessed by voice range profile and the Voice Handicap Index [VHI-9]). - No changes in swallowing function, based on the MD Anderson Dysphagia Inventory (MDADI) and the swallowing test (Dysphagia Severity Scale).

Secondary

MeasureTime frame
- Influence of patient demographics (age, initial diagnosis) and previous surgeries on treatment outcome. - Evaluation of subjective treatment success (patient satisfaction).

Countries

Germany

Contacts

Public ContactAmelita Ismalaja

Klinikum Stuttgart

a.ismalaja@klinikum-stuttgart.de+4915736968324

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026