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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peristomal Infection Rate, Postinterventional Bleeding, Postinterventional Mortality Rate

Intervention / Treatment
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* Procedure: Pull-PEG with Gastropexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard pull-PEG<br>Standard pull-PEG In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer. | |
| Active Comparator: Pull-PEG with gastropexy<br>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. | Procedure: Pull-PEG with Gastropexy<br>* Additionally to a conventional pull-PEG a gastropexy will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pull-PEG, Pull-PEG with gastropexy, Peristomal infection rate