Clinical trial NCT04174976: Environmental Risk Factors of Mesh Infection After Abdominal Wall Hernia Repair
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Site Infection
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted for wall hernia repair with mesh between 28/12/2017 and 01/01/2021 (expected number of approximately 300 patients) for which follow-up data will be available during the first post-operative year

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020

Exclusion Criteria:

* Emergency surgery
* Laparoscopic
* Pregnancy
* Adults under legal guardianship

Primary outcomes:
measure: Number of participants with surgical site infection
timeFrame: up to 1 year
Secondary outcomes:
measure: Number of participants with surgery for mesh explantation
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Nancy
country: France
facility: Estelle Vigneron
Study officials:
affiliation: CHU NANCY
name: Estelle Vigneron
role: PRINCIPAL_INVESTIGATOR
References: