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SiReDu - Silikone Ring and Pouch Resizing for Dumping Syndrome Trial

SiReDu - Silikone Ring and Pouch Resizing for Dumping Syndrome Trial - SiReDu

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020293
Enrollment
16
Registered
2020-04-14
Start date
2020-03-13
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

K91.1

Interventions

Group 1: Pouchresizing and Silicone ring implantation

Sponsors

Uniklinik Freiburg, Department Chirurgie, Klinik für Allgemein und Viszeralchirugie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient with gastric Bypass clinically relevant dumping syndrome unsuccessfull conservative treatment Inidication for operative revision Patient older than 18 years

Exclusion criteria

Exclusion criteria: Insulin dependent Type 2 Diabetes at time of Revision Typ 1 Diabetes Pregnancy Severe psychiatric illness, that has not been trated Drug abuse Liver cirrhosis alcohol abuse M. Crohn

Design outcomes

Primary

MeasureTime frame
Dumpingscore (Sigstadscore) determined via a questionnaire after 3 and 12 months

Secondary

MeasureTime frame
AUC of Mixed Meal Tolerance Tests Individual Values of Mixed Meal Tolerance Tests. This test is performed after 12 months Dumpingscore (Arts Score) determined via questionnaire at 3 and 12 months Body weight recorded after 3 and 12 months Quantitiy of consumption of carbohydates recorded after 3 and 12 months Quality of life determined via a questionnaire (BAROS) at 3 and 12 months Reflux, Regurgitation und Dysphagia after Revision, determined after 3 and 12 months

Countries

Germany

Contacts

Public ContactJodok Fink

Uniklinik Freiburg, Department Chirurgie, Klinik für Allgemein und Viszeralchirugie

jodok.fink@uniklinik-freiburg.de0049-761-270-29420

Outcome results

None listed

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