Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy
NCT ID: NCT04476498
Last Updated: 2023-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2020-07-15
2022-08-03
Brief Summary
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Detailed Description
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This randomised study wants to compare the peristomal infection rate of standard pull-PEGs and pull-PEGs with gastropexy suture. Peristomal infection rate is detected by classical inflammation rates including erythema, exsudates, and induration, development of pus, or focal peritonitis.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Standard pull-PEG
Standard pull-PEG
In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer.
No interventions assigned to this group
Pull-PEG with gastropexy
Pull-PEG with gastropexy
In this group the participants firstly receive a gastropexy with the Funada style gastropexy device. Afterwards a conventional pull-PEG will be inserted.
Pull-PEG with Gastropexy
Additionally to a conventional pull-PEG a gastropexy will be performed.
Interventions
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Pull-PEG with Gastropexy
Additionally to a conventional pull-PEG a gastropexy will be performed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* female patients who are pregnant or breast feeding
* existing contraindications for a PEG-implantation
18 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Georg Dultz
Senior physician
Principal Investigators
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Mireen Friedrich-Rust, Professor
Role: STUDY_CHAIR
Johann Wolfgang Goethe University Hospital
Locations
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Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Hesse, Germany
Countries
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Other Identifiers
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JWGUHMED1-013
Identifier Type: -
Identifier Source: org_study_id
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