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Collection of non-cardiac sequelae after Fontan operation in childhood and adolescence.

Collection of non-cardiac sequelae after Fontan operation in childhood and adolescence.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039018
Enrollment
361
Registered
2026-05-13
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Q20-Q28

Interventions

Group 1: Retrospective analysis of all patients who were treated at our centre with a status-post Fontan operation between 01 Nov 2020 and 01 Nov 2025. In this retrospective single-center cohort study

Sponsors

Universtätsklinikum Bonn, Zentrum für Kinderheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Patients who have undergone a Fontan operation and are receiving pediatric care at the Center for Pediatrics of the University Hospital Bonn.

Exclusion criteria

Exclusion criteria: Incomplete documentation for the primary endpoints.

Design outcomes

Primary

MeasureTime frame
Primary endpoints: Incidence of Fontan-associated liver disease (FALD) and intestinal protein-losing syndrome (PLE). These conditions may arise at any point during the observation period and will be documented accordingly. The data will be extracted from the documentation available in the hospital information system.

Secondary

MeasureTime frame
Severity and clinical consequences of FALD (e.g., ascites, varices, liver transplantation, liver function tests, elastography scores) Complications of PLE (hypogammaglobulinemia, increased susceptibility to infections, hospitalization rate) Overall mortality and cardiovascular mortality Identification of risk factors / prognostic factors

Countries

Germany

Contacts

Public ContactRainer Ganschow

Universtätsklinikum Bonn, Zentrum für Kinderheilkunde

rainer.ganschow@ukbonn.de+4922828733213

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026