NCT07491250

Brief 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. 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.

Trial Health

65
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

March 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

Inguinal hernia repairmesh infectioncomplete mesh removalpartial mesh removal

Outcome Measures

Primary Outcomes (2)

  • Hernia Recurrence Rate

    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

    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

Study Arms (2)

The complete mesh removal group

Procedure: Complete mesh removal

The partial mesh removal group

Procedure: Partial mesh removal

Interventions

Total explantation of the entire prosthetic mesh, including all visible portions and fixation sutures, regardless of the extent of infection.

The complete 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.

The partial mesh removal group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share