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

Peristomal Infection Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476498
• Other study ID #: JWGUHMED1-013
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: September 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 3, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Peristomal Infection Rate
• Postinterventional Bleeding
• Postinterventional Mortality Rate

Intervention

Procedure:
• Pull-PEG with Gastropexy
Additionally to a conventional pull-PEG a gastropexy will be performed.

Locations

Country	Name	City	State
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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