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HErnias REparation After Kidney Transplantation Study (HEREKT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730492
Recruitment Status : Completed
First Posted : January 29, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief 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.

Condition or disease
Prosthesis User Renal Transplantation

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
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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant
Actual Study Start Date : November 30, 2020
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Renal Transplantation
Renal Transplantation
Hernias reparation post renal transplantation
Hernias reparation post renal transplantation


Outcome Measures
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Primary Outcome Measures :
  1. disembowelment number in FIG / D [ Time Frame: 1 day ]
    disembowelment number in FIG / D


Secondary Outcome Measures :
  1. type of wall closure technique in the context of a kidney transplant [ Time Frame: 1 day ]
    type of wall closure technique in the context of a kidney transplant


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who have received renal transplantation with post-incisionale hernia
Criteria

Inclusion criteria:

- hernia post renal transplantation

Exclusion criteria:

- underage

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730492


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Fabrizio PANARO, PhD UH MONTPELLIER
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04730492    
Other Study ID Numbers: RECHMPL20_0594
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
renal transplantation
post incision hernia
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical