NCT06682091

Brief Summary

Hernia repair is among most frequent surgical interventions. The use of abdominal mesh in hernia repair has become the Gold Standard strategy, reducing the risk of relapse. The mesh infection risk is estimated lower than 1% in simple situations, but can increase up to 20% in complicated patients. Risk factors are well known, but we lack data regarding the therapeutic strategies and outcomes. This study aims to describe the characteristics and management of abdominal mesh infections, and the related outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

10 years

First QC Date

June 7, 2024

Last Update Submit

November 8, 2024

Conditions

Abdominal Infection

Keywords

mesh infectionabdominoplasty

Outcome Measures

Primary Outcomes (1)

  • Treatment failure.

    Clinical failure = persistance of the infection. Time of failure is the time of change of therapeutic strategy.

    Retrospective analysis from initial treatment to any treatment failure within 2010 to 2023

Study Arms (1)

Cohort of patients admitted for an abdominal mesh infection at Hospices Civils de Lyon

No intervention. Retrospective data collection.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects taken in care for abdominal mesh infection in the Hospices Civils de Lyon from 2010 to 2023.

You may qualify if:

  • parietal mesh infection
  • age \> 18

You may not qualify if:

  • Non French speaking patients.
  • Persons under tutorship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2024

First Posted

November 12, 2024

Study Start

January 1, 2013

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)