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

Primary Purpose

Peristomal Infection Rate, Postinterventional Bleeding, Postinterventional Mortality Rate

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pull-PEG with Gastropexy
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peristomal Infection Rate focused on measuring Pull-PEG, Pull-PEG with gastropexy, Peristomal infection rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinikum der J. W. Goethe-Universität

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard pull-PEG

Pull-PEG with gastropexy

Arm Description

Standard pull-PEG In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2020
Last Updated
July 12, 2023
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04476498
Brief Title
Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy
Official Title
Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peristomal Infection Rate, Postinterventional Bleeding, Postinterventional Mortality Rate
Keywords
Pull-PEG, Pull-PEG with gastropexy, Peristomal infection rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
Masking
Participant
Masking Description
The participants don't know which arm they were allocated to.
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard pull-PEG
Arm Type
No Intervention
Arm Description
Standard pull-PEG In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer.
Arm Title
Pull-PEG with gastropexy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pull-PEG with Gastropexy
Intervention Description
Additionally to a conventional pull-PEG a gastropexy will be performed.
Primary Outcome Measure Information:
Title
Peristomal infection rate
Description
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
Title
Postinterventional bleeding
Description
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
Title
Postinterventional occurrence of fistulas
Description
Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireen Friedrich-Rust, Professor
Organizational Affiliation
Universitätsklinikum Frankfurt
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum der J. W. Goethe-Universität
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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