Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:56 AM
Study NCT ID:
NCT07491250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesh Infection After Hernioplasty: Complete vs Partial Removal - Retrospective Study on Outcomes and Pathogen Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia Recurrence Rate', 'timeFrame': 'From date of surgery to December 2025', 'description': 'Presence of clinically or radiologically confirmed recurrent inguinal hernia at the site of previous hernioplasty following mesh removal surgery.'}, {'measure': 'Infection Recurrence Rate', 'timeFrame': 'From date of surgery to December 2025', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inguinal hernia repair', 'mesh infection', 'complete mesh removal', 'partial mesh removal'], 'conditions': ['Inguinal Hernia Repair', 'Mesh Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nMaterials 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.', 'detailedDescription': '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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who underwent tension-free inguinal hernioplasty with mesh placement.\n2. Patients diagnosed with mesh infection requiring surgical re-intervention.\n3. Patients who underwent complete or partial mesh removal surgery.\n4. Availability of complete medical records and follow-up data.\n\nExclusion Criteria:\n\n1. Patients with mesh infection managed conservatively (without surgical removal).\n2. Patients with missing critical data (e.g., intraoperative findings, pathogen results, or follow-up).\n3. Patients with concomitant procedures that could confound outcomes (e.g., simultaneous other hernia repair).\n4. Patients lost to follow-up immediately after discharge (no postoperative assessment).'}, 'identificationModule': {'nctId': 'NCT07491250', 'briefTitle': 'Mesh Infection After Hernioplasty: Complete vs Partial Removal - Retrospective Study on Outcomes and Pathogen Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Retrospective Study: Complete vs Partial Mesh Removal for Mesh Infection After Hernioplasty - Clinical Outcomes and Pathogen Analysis', 'orgStudyIdInfo': {'id': 'HuadongHosptialHernia02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The complete mesh removal group', 'interventionNames': ['Procedure: Complete mesh removal']}, {'label': 'The partial mesh removal group', 'interventionNames': ['Procedure: Partial mesh removal']}], 'interventions': [{'name': 'Complete mesh removal', 'type': 'PROCEDURE', 'description': 'Total explantation of the entire prosthetic mesh, including all visible portions and fixation sutures, regardless of the extent of infection.', 'armGroupLabels': ['The complete mesh removal group']}, {'name': 'Partial mesh removal', 'type': 'PROCEDURE', 'description': 'Excision of only the infected or non-incorporated portion of the mesh, with preservation of the well-incorporated, uninfected segment left in situ.', 'armGroupLabels': ['The partial mesh removal group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaoyu Peng, MD', 'role': 'CONTACT', 'email': '23211280025@m.fudan.edu.cn', 'phone': '+8619121706827'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhijun Bao', 'investigatorAffiliation': 'Fudan University'}}}}