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

  • STATUS
    Recruiting
  • End date
    Jul 15, 2023
  • participants needed
    122
  • sponsor
    Johann Wolfgang Goethe University Hospital
Updated on 25 January 2021

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.

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.

Details
Condition Peristomal Infection Rate, Postinterventional Bleeding, Postinterventional Mortality Rate
Treatment Pull-PEG with Gastropexy
Clinical Study IdentifierNCT04476498
SponsorJohann Wolfgang Goethe University Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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