Peristomal Infection RateNCT04476498
Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy
A study testing Pull-PEG with Gastropexy in people with Peristomal Infection Rate and Postinterventional Bleeding, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peristomal Infection Rate, Postinterventional Bleeding, Postinterventional Mortality Rate
- What is being tested?
- Pull-PEG with Gastropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2020to 3 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over with an indication for a PEG-insertion
Who cannot join
- ASA-classification >4
- female patients who are pregnant or breast feeding
- existing contraindications for a PEG-implantation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, Hesse, 60590
About this study
Official title: 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.
Read the 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.
- Being tested
- Pull-PEG with Gastropexy
- Keywords
- Pull-PEG, Pull-PEG with gastropexy, Peristomal infection rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pull-PEG with GastropexyProcedure or surgery
Additionally to a conventional pull-PEG a gastropexy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Standard pull-PEG | No intervention | Standard pull-PEG In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer. |
| Pull-PEG with gastropexy | Active comparator | 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. Receives: Procedure: Pull-PEG with Gastropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Jul 2020
- Primary completion18 Jul 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peristomal Infection RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Dultz, Johann Wolfgang Goethe University Hospital
- Investigators
- Mireen Friedrich-Rust, Professor, Study chair, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476498
- Sponsor's protocol ID
- JWGUHMED1-013
- Status last verified
- Sep 2020
- First submitted
- 15 Jul 2020
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy
- ClinicalTrials.gov ID
- NCT04476498
- Acronym / sponsor ID
- JWGUHMED1-013
- Keywords
- Pull-PEG, Pull-PEG with gastropexy, Peristomal infection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Standard pull-PEG | No intervention | –Standard pull-PEG In this group the participants receive a conventional pull-PEG as firstly described by Ponsky and Gauderer. |
| Pull-PEG with gastropexy | Active comparator | Procedure: Pull-PEG with GastropexyPull-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 and over with an indication for a PEG-insertion
Key exclusion criteria (3 listed)
- ASA-classification >4
- female patients who are pregnant or breast feeding
- existing contraindications for a PEG-implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pull-PEG with GastropexyAdditionally to a conventional pull-PEG a gastropexy will be performed. | Procedure or surgery | Pull-PEG with gastropexy |
Primary outcome
Peristomal infection rate
Time frame: 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).
Postinterventional bleeding
Time frame: 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
Time frame: 36 months
Occurence of fistulas after PEG-insertion with and without gastropexy will be detected by clinical signs and laboratory parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireen Friedrich-Rust, Professor study chair
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pull-PEG with Gastropexy in people with Peristomal Infection Rate and Postinterventional Bleeding, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristomal infection rate (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.