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

Not Applicable

Completed

• Conditions: Postinterventional Mortality Rate; Peristomal Infection Rate; Postinterventional Bleeding

• Registration Number: NCT04476498
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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.

Study Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Status Verified: 2020-09
• Primary Completion: 2022-07-18
• Study Completion: 2022-08-03
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peristomal infection rate	36 months	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).
Postinterventional bleeding	36 months	Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters
Postinterventional occurrence of fistulas	36 months	Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters

Trial Locations

Locations (1)

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Hessen, Germany