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

Johann Wolfgang Goethe University Hospital

Status: Completed

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

Treatments: Procedure: Pull-PEG with Gastropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT04476498

JWGUHMED1-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Standard pull-PEG

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Procedure: Pull-PEG with Gastropexy