Prosthesis UserHEREKTNCT04730492
HErnias REparation After Kidney Transplantation Study
An observational study of Prosthesis User and Renal Transplantation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis User, Renal Transplantation
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2020to 28 Feb 2021
- Phase
- Observational
- 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
Study population: patients who have received renal transplantation with post-incisionale hernia
Who may be able to join
- hernia post renal transplantation
Who cannot join
- underage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant
Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.
Read the detailed description
In the scientific literature, the percentage of post incisional hernia in kidney transplanted patients is very variable, and not too well-argued, especially in the context of prevention and individuation of risk factors.
The increase of surgical management of hernias reparation in renal transplant patients justifies the start of a mon-centric type study. The investigators will look for risk factors with a retrospective, observational study, by analyzing the type of surgical repair of their post-surgical wall defect.
The analysis of costs/benefits on postoperative, intraoperative, or preoperative prevention will be taken into account.
- Conditions
- Prosthesis User, Renal Transplantation
- Keywords
- renal transplantation, post incision hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal Transplantation | Renal Transplantation | |
| Hernias reparation post renal transplantation | Hernias reparation post renal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disembowelment number in FIG / D
disembowelment number in FIG / D
Measured: 1 day
Secondary outcomes (1)
type of wall closure technique in the context of a kidney transplant
type of wall closure technique in the context of a kidney transplant
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start30 Nov 2020
- Primary completion30 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio PANARO, PhD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730492
- Sponsor's protocol ID
- RECHMPL20_0594
- Acronym
- HEREKT
- Status last verified
- May 2021
- First submitted
- 25 Jan 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant
- ClinicalTrials.gov ID
- NCT04730492
- Acronym / sponsor ID
- HEREKT / RECHMPL20_0594
- Conditions
- Prosthesis User, Renal Transplantation
- Keywords
- renal transplantation, post incision hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 29 Jan 2021 (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.
Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.
Detailed description
In the scientific literature, the percentage of post incisional hernia in kidney transplanted patients is very variable, and not too well-argued, especially in the context of prevention and individuation of risk factors.
The increase of surgical management of hernias reparation in renal transplant patients justifies the start of a mon-centric type study. The investigators will look for risk factors with a retrospective, observational study, by analyzing the type of surgical repair of their post-surgical wall defect.
The analysis of costs/benefits on postoperative, intraoperative, or preoperative prevention will be taken into account.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Transplantation | – | –Renal Transplantation |
| Hernias reparation post renal transplantation | – | –Hernias reparation post renal transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have received renal transplantation with post-incisionale hernia
Key inclusion criteria (1 listed)
- hernia post renal transplantation
Key exclusion criteria (1 listed)
- underage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disembowelment number in FIG / D
Time frame: 1 day
disembowelment number in FIG / D
1 secondary outcome
type of wall closure technique in the context of a kidney transplant
Time frame: 1 day
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 6 May 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Fabrizio PANARO, PhD study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis User and Renal Transplantation, run by University Hospital, Montpellier at 1 site in France.
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 1 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 6 May 2021. 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 France. 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?
disembowelment number in FIG / D (time frame: 1 day). 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 6 May 2021.