Peristomal Infection Rate Clinical Trial
Official title:
Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy
Verified date | September 2020 |
Source | Johann Wolfgang Goethe University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to compare the conventional pull-percutaneous endoscopic gastrostomy (pull-PEG) with a pull-PEG with gastropexy suture regarding the peristomal infection rate.
Status | Completed |
Enrollment | 122 |
Est. completion date | August 3, 2022 |
Est. primary completion date | July 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged 18 and over with an indication for a PEG-insertion Exclusion Criteria: - ASA-classification >4 - female patients who are pregnant or breast feeding - existing contraindications for a PEG-implantation |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum der J. W. Goethe-Universität | Frankfurt am Main | Hessen |
Lead Sponsor | Collaborator |
---|---|
Johann Wolfgang Goethe University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peristomal infection rate | Peristomal infection rate will be compared after conventional pull-PEG and pull-PEG with gastropexy. Peristomal infection is detected classical inflammation parameters (erythema, indulation, exsudate, ulcer and bleeding). | 36 months | |
Primary | Postinterventional bleeding | Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters | 36 months | |
Primary | Postinterventional occurrence of fistulas | Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters | 36 months |