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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04476498

Enrollment

122

Registered

2020-07-20

Start date

2020-07-15

Completion date

2022-08-03

Last updated

2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peristomal Infection Rate, Postinterventional Bleeding, Postinterventional Mortality Rate

Keywords

Pull-PEG, Pull-PEG with gastropexy, Peristomal infection rate

Brief 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.

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.

Interventions

PROCEDUREPull-PEG with Gastropexy

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

The participants don't know which arm they were allocated to.

Intervention model description

This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Postinterventional bleeding	36 months	Postinterventional bleeding after PEG insertion with and without gastropexy will be observed by clinical bleeding signs and control of laboratory parameters
Postinterventional occurrence of fistulas	36 months	Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters
Peristomal infection rate	36 months	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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026