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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.
Pull-percutaneous endoscopic gastrostomy (Pull-PEG) is currently the standard technique for enteral nutrition in patients with swallowing disorders. Fistula and peristomal infection rates are one of the most common early complications which are caused by bacterial transmission through the oropharyngeal passage of the tube and by bacterial translocation out of the stomach into the abdominal wall. Retrospective data have shown that if pull-PEGs are attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and peristomal infection rates can be reduced significantly.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard pull-PEG | No Intervention | Standard pull-PEG In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer. | |
| Pull-PEG with gastropexy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pull-PEG with Gastropexy | Procedure | Additionally to a conventional pull-PEG a gastropexy will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mireen Friedrich-Rust, Professor | Johann Wolfgang Goethe University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der J. W. Goethe-Universität | Frankfurt am Main | Hesse | 60590 | Germany |
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| ID | Term |
|---|---|
| D059485 | Gastropexy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
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The participants don't know which arm they were allocated to.