Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT06679504
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2024-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '7 days, 15 days, 1 month, 2 months, and 3 months.', 'description': 'The postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire. The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The higher scores mean better quality of life..'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain assessment', 'timeFrame': '7 days, 15 days, 1 month, 2 months, and 3 months.', 'description': 'VAS; visual analogue scale. for pain assessment. the score ranges from 1-10... higher score denotes more pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.', 'detailedDescription': 'A wide variety of mesh fixation techniques are available for laparoscopic hernia repair. These can be broadly divided into mechanical and nonmechanical methods. Mechanical methods include sutures and tissue penetrating fixation devices like tackers. Nonmechanical techniques include self-gripping meshes and tissue adhesives (glues).\n\nMechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. On the other hand, nonmechanical methods do not have these disadvantages.\n\nFurthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. To the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. Therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients complain of uncomplicated inguinal hernia who are scheduled for laparoscopic TEP hernioplasty', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age group of 18-60 years.\n2. All types of inguinal hernias.\n3. Didn't undergo pervious hernia repair surgery.\n\nExclusion Criteria:\n\n1. Patients who are unfit for general anesthesia or with American Society of Anesthesiologists (ASA) grade 3 and above.\n2. Presence of other groin or abdominal hernias.\n3. Patients with complicated hernias such as irreducibility, obstruction, and incarceration.\n4. Patients with obesity or morbid obesity BMI \\>= 35."}, 'identificationModule': {'nctId': 'NCT06679504', 'briefTitle': 'Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Quality of Life After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation', 'orgStudyIdInfo': {'id': '#4846/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibrin glue group', 'description': 'Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue', 'interventionNames': ['Procedure: Fibrin glue fixation']}, {'label': 'Tack fixation group', 'description': 'Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation', 'interventionNames': ['Procedure: Tack fixation']}], 'interventions': [{'name': 'Fibrin glue fixation', 'type': 'PROCEDURE', 'description': 'Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation', 'armGroupLabels': ['Fibrin glue group']}, {'name': 'Tack fixation', 'type': 'PROCEDURE', 'description': 'Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation', 'armGroupLabels': ['Tack fixation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'Sameh Tolba, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Suez canal University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant and lecturer of Surgery', 'investigatorFullName': 'Waleed Ghareeb', 'investigatorAffiliation': 'Suez Canal University'}}}}