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Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG.
BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire.
In this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy | Active Comparator | Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife. |
|
| Flamingo Device | Experimental | The Flamingo device is used for treatment of Buried Bumper Syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flamingo Device | Device | Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time for Removal of PEG | Assessed at day 1 (day of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | Assessed at day 1 | |
| Complications | Assessed during follow-up for up to ten days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Ludwigsburg | 71640 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37543062 | Derived | Wannhoff A, Kullmer A, Albers D, Fahndrich M, Ganten T, Wettstein M, Meier B, Schumacher B, Schmidt A, Caca K. Prospective randomized controlled trial comparing a novel and dedicated device with conventional endoscopic techniques for the treatment of buried bumper syndrome (with video). Gastrointest Endosc. 2024 Jan;99(1):23-30.e1. doi: 10.1016/j.gie.2023.07.048. Epub 2023 Aug 3. |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Therapy | Procedure | Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife |
|