Inguinal Hernia RepairNCT07491250
Mesh Infection After Hernioplasty: Complete vs Partial Removal - Retrospective Study on Outcomes and Pathogen Analysis
An observational study of Inguinal Hernia Repair and Mesh Infection, run by Fudan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia Repair, Mesh Infection
- What is being tested?
- Complete mesh removal and Partial mesh removal
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients who developed mesh infection after tension-free inguinal hernioplasty and subsequently underwent surgical mesh removal (either complete or partial) at our institution. Data were collected retrospectively from medical records, including demographic characteristics, comorbidities, laboratory and imaging results, primary hernia surgery details, infection characteristics, intraoperative data, and postoperative outcomes. Follow-up was conducted through outpatient visits and telephone interviews, with the last follow-up on October 30, 2025.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia Repair, Mesh Infection
- Being tested
- Complete mesh removal, Partial mesh removal
- Keywords
- Inguinal hernia repair, mesh infection, complete mesh removal, partial mesh removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete mesh removalProcedure or surgery
Total explantation of the entire prosthetic mesh, including all visible portions and fixation sutures, regardless of the extent of infection.
Partial mesh removalProcedure or surgery
Excision of only the infected or non-incorporated portion of the mesh, with preservation of the well-incorporated, uninfected segment left in situ.
| Study group | Role | What they receive |
|---|---|---|
| The complete mesh removal group | Not described Receives: Procedure: Complete mesh removal | |
| The partial mesh removal group | Not described Receives: Procedure: Partial mesh removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence Rate
Presence of clinically or radiologically confirmed recurrent inguinal hernia at the site of previous hernioplasty following mesh removal surgery.
Measured: From date of surgery to December 2025
Infection Recurrence Rate
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.
Measured: From date of surgery to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start18 Mar 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491250
- Sponsor's protocol ID
- HuadongHosptialHernia02
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study: Complete vs Partial Mesh Removal for Mesh Infection After Hernioplasty - Clinical Outcomes and Pathogen Analysis
- ClinicalTrials.gov ID
- NCT07491250
- Acronym / sponsor ID
- HuadongHosptialHernia02
- Conditions
- Inguinal Hernia Repair, Mesh Infection
- Keywords
- Inguinal hernia repair, mesh infection, complete mesh removal, partial mesh removal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The complete mesh removal group | – | Procedure: Complete mesh removal |
| The partial mesh removal group | – | Procedure: Partial mesh removal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who developed mesh infection after tension-free inguinal hernioplasty and subsequently underwent surgical mesh removal (either complete or partial) at our institution. Data were collected retrospectively from medical records, including demographic characteristics, comorbidities, laboratory and imaging results, primary hernia surgery details, infection characteristics, intraoperative data, and postoperative outcomes. Follow-up was conducted through outpatient visits and telephone interviews, with the last follow-up on October 30, 2025.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete mesh removalTotal explantation of the entire prosthetic mesh, including all visible portions and fixation sutures, regardless of the extent of infection. | Procedure or surgery | The complete mesh removal group |
| Partial mesh removalExcision of only the infected or non-incorporated portion of the mesh, with preservation of the well-incorporated, uninfected segment left in situ. | Procedure or surgery | The partial mesh removal group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia Repair and Mesh Infection, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Peng, MD (+8619121706827, 23211280025@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence Rate (time frame: From date of surgery to December 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.