NCT04476498

Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy

Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peristomal Infection Rate
• Postinterventional Bleeding
• Postinterventional Mortality Rate

Interventions

Type	Name	Description
PROCEDURE	Pull-PEG with Gastropexy	Additionally to a conventional pull-PEG a gastropexy will be performed.

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-07-18
• Completion: 2022-08-03
• First posted: 2020-07-20
• Last updated: 2023-07-13

Locations

1 site across 1 country: Germany