Effectivity and safety of the therapy of buried bumper syndrome – a retrospective multicenter trial

• Conditions: T85.51; T85.74

• Registration Number: DRKS00030694
• Lead Sponsor: Viszeralmedizinisches Zentrum, Evangelisches Diakoniekrankenhaus Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study Completion: 2023-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

All diagnosed and treated Buried bumper syndromes in the participating hospitals

Exclusion Criteria

none

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful intervention (=mobilisation of the buried bumper) in one session (yes/no).

Secondary Outcome Measures

Name	Time	Method
type of treatment (none/ laparotomy/ laparoscopy/ incision from the outside/ Push- und Pull-maneuver/ needle-knife/ papillotome/ ESD-knife/ APC/ combination of techniques/ others), successful intervention after one or more sessions (yes/no), number of sessions, further pretherapeutic diagnostics (none/ ultrasound/ CT scan/ others), duration of intervention(s), alternative therapy in case of unsuccessful treatment (none/ endoscopic/ surgery), kind of Buried bumper (incomplete/ complete), intraprocedural bleeding (yes/no), complications (yes/no), kind of complications (bleeding intra- or postprocedural/ perforation/ peritonitis/ pneumonia/ intestinal atony/ wound healing disorder/ others), therapy of complications (endoscopic/ surgery/ conservative), death (yes/no), new PEG (yes, in the same session/ yes, in 2nd session/ yes, surgical/ no), kind of new PEG (balloon-PEG/ conventional PEG), localisation of the new PEG (present channel/ new channel)