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UnknownNCT04174976

Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair

Morbidity of Abdominal Wall Hernia Reconstruction With Mesh: Study of Environmental Risk Factors in the Operating Room in the CHRU of Nancy- a Prospective Study

Status
Unknown
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity. Within our digestive surgery department (CHRU de Nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between January 2016 and December 2018. This rate is higher than those usually described in the literature. Several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. The influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied. If the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk. The main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction

Detailed description

It's a prospective, mono-centric study carried out on a cohort of patients followed in the digestive surgery department of the CHRU of Nancy All patients who underwent a wall hernia repair between 28/12/2017 and 28/12/2020 in the digestive and general surgery department of the CHU of Nancy were included. During the operative time, the nurses have to fill a survey with characteristics specific to the intervention and the operating environment. Patients in this study have been followed for at least one year at the Nancy CHRU in order to be aware of the occurence of mesh infection and surgery for mesh explantation.

Conditions

Interventions

TypeNameDescription
PROCEDUREwall hernia repairWall hernia repair with mesh

Timeline

Start date
2017-12-28
Primary completion
2021-01-01
Completion
2022-01-01
First posted
2019-11-22
Last updated
2019-12-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04174976. Inclusion in this directory is not an endorsement.

Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair (NCT04174976) · Clinical Trials Directory