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Bougie CAP in the treatment of benign oesophagus stenosis: randomised controlled pilot study

Bougie CAP in the treatment of benign oesophagus stenosis: randomised controlled pilot study - BOUGIE-PED

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00018996
Enrollment
80
Registered
2019-10-14
Start date
2019-10-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K22.2 K20 K21.0 K91.83 Q39 Q87 T28.6

Interventions

Group 1: Dilatation with Bougie Cap Group 2: Dilatation with standard method (Savary Bougie, or Ballon Dilatation).

Sponsors

Klinik für Kinder- und Jugendmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Age below 18 years with benign Stenosis and informed consent of the parents

Exclusion criteria

Exclusion criteria: Missing informed consent, untreatable Stenosis

Design outcomes

Primary

MeasureTime frame
successful opening of the stricture and passing though (yes or no)

Secondary

MeasureTime frame
QoL-Analysis (Sibergliet A. et al The dysphagia handicap index) before treatment, 1 and 14 days after treatment, Dysphagia-Score (BODS-2 Questionnaire) before treatment, 1 and 14 days after treatment, Duration of intervention (in minutes), need for change to another interventional method (Yes/No; and which), duration of Sedation (in minutes)

Countries

Germany

Contacts

Public ContactCarsten Posovszky

Klinik für Kinder- und Jugendmedizin

carsten.posovszky@uniklinik-ulm.de0731-50057470

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026