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

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

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.

Study Overview

• Status: Completed
• Conditions: Peristomal Infection Rate; Postinterventional Bleeding; Postinterventional Mortality Rate
• Intervention / Treatment: Procedure: Pull-PEG with Gastropexy

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireen Friedrich-Rust, Professor; Phone Number: 06963015333; Email: mireen.friedrich-rust@kgu.de
• Study Contact Backup: Name: Christiana Graf, MD; Phone Number: 06963015333; Email: christiana.graf@kgu.de

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Klinikum der J. W. Goethe-Universität

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard pull-PEG; 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; 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; Additionally to a conventional pull-PEG a gastropexy will be performed.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Study Chair: Mireen Friedrich-Rust, Professor, Universitätsklinikum Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Pull-PEG; Pull-PEG with gastropexy; Peristomal infection rate
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: JWGUHMED1-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No