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

Johann Wolfgang Goethe University Hospital122 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

122

Conditions

Peristomal Infection Rate Postinterventional Bleeding Postinterventional Mortality Rate

Interventions

Pull-PEG with GastropexyPROCEDURE

Additionally to a conventional pull-PEG a gastropexy will be performed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

Peristomal infection rate

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).

Time frame: 36 months

Postinterventional bleeding

Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters

Time frame: 36 months

Postinterventional occurrence of fistulas

Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters

Time frame: 36 months

Data from ClinicalTrials.gov

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