- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491250
Mesh Infection After Hernioplasty: Complete vs Partial Removal - Retrospective Study on Outcomes and Pathogen Analysis
A Retrospective Study: Complete vs Partial Mesh Removal for Mesh Infection After Hernioplasty - Clinical Outcomes and Pathogen Analysis
Background: Mesh infection after tension-free inguinal hernia repair (IHR) is rare and challenging. When conservative treatment fails, surgery is often required. This study compared clinical outcomes of complete versus partial mesh removal in affected patients.
Materials and Methods: We retrospectively analyzed patients who underwent surgery for mesh infection after IHR in our hospital between January 2016 and December 2025. Baseline data, perioperative indicators, postoperative complications, and microbiological results were compared between the complete and partial removal groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We conducted a single-center, retrospective case series analysis. We included patients who developed mesh infection after tension-free IHR and underwent surgical treatment at our center between January 2016 and December 2025. Patients with mesh infection after incisional, parastomal, or umbilical hernia repair were excluded. We also excluded patients who improved with conservative treatment and did not undergo surgery.
We collected the following data: demographic characteristics, comorbidities, laboratory and imaging results, characteristics of the primary hernia surgery, infection characteristics, intraoperative data, and postoperative outcomes. All data were entered into a standardized database. Follow-up was conducted through outpatient visits and telephone interviews. The last follow-up was on October 30, 2025.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiaoyu Peng, MD
- Phone Number: +8619121706827
- Email: 23211280025@m.fudan.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who underwent tension-free inguinal hernioplasty with mesh placement.
- Patients diagnosed with mesh infection requiring surgical re-intervention.
- Patients who underwent complete or partial mesh removal surgery.
- Availability of complete medical records and follow-up data.
Exclusion Criteria:
- Patients with mesh infection managed conservatively (without surgical removal).
- Patients with missing critical data (e.g., intraoperative findings, pathogen results, or follow-up).
- Patients with concomitant procedures that could confound outcomes (e.g., simultaneous other hernia repair).
- Patients lost to follow-up immediately after discharge (no postoperative assessment).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
The complete mesh removal group
|
Total explantation of the entire prosthetic mesh, including all visible portions and fixation sutures, regardless of the extent of infection.
|
|
The partial mesh removal group
|
Excision of only the infected or non-incorporated portion of the mesh, with preservation of the well-incorporated, uninfected segment left in situ.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hernia Recurrence Rate
Time Frame: From date of surgery to December 2025
|
Presence of clinically or radiologically confirmed recurrent inguinal hernia at the site of previous hernioplasty following mesh removal surgery.
|
From date of surgery to December 2025
|
|
Infection Recurrence Rate
Time Frame: From date of surgery to December 2025
|
Recurrence of surgical site infection at the same location after initial surgical treatment for mesh infection, confirmed by clinical signs (e.g., erythema, purulent drainage, sinus tract formation) and/or positive microbiological culture.
|
From date of surgery to December 2025
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HuadongHosptialHernia02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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