Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06240858
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2024-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of moderate to severe pain at 3 and 6 months after surgery.', 'timeFrame': '3 and 6 months after surgery.', 'description': 'Visual analogue scale (VAS) was used to score the postoperative pain at 3 and 6 months. The score ranges from 0 (no pain) to 10 (most severe pain).'}], 'secondaryOutcomes': [{'measure': 'Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.', 'timeFrame': '3 and 6 months after surgery.', 'description': 'Recurrence of inguinal hernia after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-gripping mesh', 'Laparoscopy', 'Herniorrhaphy'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.\n\nParticipants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.\n\nResearchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients aged 18 years and older were selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 18 years and older.\n* Patients with a definite diagnosis of unilateral primary inguinal hernia.\n* Patients and their families were informed about the study protocol and agreed to participate in the study.\n\nExclusion Criteria:\n\n* Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.\n* Patients with previous history of lower abdominal surgery.\n* Patients with contraindications to anaesthesia.\n* Patients with contraindications to laparoscopic surgery.\n* Failure to follow up patients as scheduled.\n* Patients with abdominal infections.\n* Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.'}, 'identificationModule': {'nctId': 'NCT06240858', 'briefTitle': 'Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Jilin University'}, 'officialTitle': 'Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair', 'orgStudyIdInfo': {'id': '(2022) Annual Audit No. (175)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAPP group', 'description': 'The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair.', 'interventionNames': ['Procedure: Laparoscopic transabdominal preperitoneal hernia repair.']}, {'type': 'EXPERIMENTAL', 'label': 'Lichtenstein group', 'description': 'The Lichtenstein group underwent Lichtenstein hernia repair.', 'interventionNames': ['Procedure: Lichtenstein hernia repair.']}], 'interventions': [{'name': 'Laparoscopic transabdominal preperitoneal hernia repair.', 'type': 'PROCEDURE', 'description': 'The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.', 'armGroupLabels': ['TAPP group']}, {'name': 'Lichtenstein hernia repair.', 'type': 'PROCEDURE', 'description': 'The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.', 'armGroupLabels': ['Lichtenstein group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130022', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing with other researchers is not planned at this time due to patient privacy concerns.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}