Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 7:28 PM
Study NCT ID:
NCT05934266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-02
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Mesh Fixation With Tissue Adhesive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain assessed by visual numeric scale', 'timeFrame': '6 months', 'description': 'Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.'}, {'measure': 'Postoperative administration of analgesics', 'timeFrame': '6 months', 'description': 'Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements'}], 'secondaryOutcomes': [{'measure': 'Hernia recurrence', 'timeFrame': '6 months', 'description': 'Hernia recurrence rate after mesh fixation with tissue adhesive'}, {'measure': 'Hematoma', 'timeFrame': '1 month', 'description': 'Groin hematoma following hernioplasty with n-hexyl cyanoacrylate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hernioplasty', 'mesh fixation', 'n-hexyl cyanoacrylate', 'groin hernia', 'postoperative pain'], 'conditions': ['Groin Hernia', 'Hernia, Inguinal', 'Postoperative Pain', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.', 'detailedDescription': 'Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain.\n\nThe objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective open inguinal hernioplasty in patients over 18 years old\n\nExclusion Criteria:\n\n* Patient refusal\n* Laparoscopic surgery\n* Reintervention surgery\n* Urgent surgery\n* Cyanoacrylate allergy\n* Administration of intraoperative local anesthetics\n* Comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.'}, 'identificationModule': {'nctId': 'NCT05934266', 'briefTitle': 'Impact of Mesh Fixation With Tissue Adhesive', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario de Móstoles'}, 'officialTitle': 'Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'HUMostoles'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tissue adhesive', 'description': 'Group of 80 patients in which mesh fixation is done using cyanoacrylate glue', 'interventionNames': ['Device: Use of n-hexyl cyanoacrylate for mesh fixation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard suture', 'description': 'Group of 80 patients who undergo hernioplasty with standard suture'}], 'interventions': [{'name': 'Use of n-hexyl cyanoacrylate for mesh fixation', 'type': 'DEVICE', 'description': 'Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair', 'armGroupLabels': ['Tissue adhesive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Móstoles', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario de Móstoles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgeon', 'investigatorFullName': 'Justyna Drewniak Jakubowska', 'investigatorAffiliation': 'Hospital Universitario de Móstoles'}}}}