Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-30 @ 10:04 AM
Study NCT ID:
NCT05574751
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2022-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-19', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]', 'timeFrame': '7 days after the end of the operation', 'description': 'NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)'}, {'measure': 'Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)', 'timeFrame': '7 days after the end of the operation', 'description': 'NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)'}], 'secondaryOutcomes': [{'measure': 'Mean and Standard deviation of Operative duration (minutes) (mean±SD)', 'timeFrame': '2 minutes after the end of the operation', 'description': 'Time from skin incision till skin closure'}, {'measure': 'Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)', 'timeFrame': '24 hours after the end of the operation', 'description': 'Time from hospital admission till discharge'}, {'measure': 'Number of participants and Rate of Intraoperative complications', 'timeFrame': '2 minutes after the end of the operation', 'description': 'Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury.'}, {'measure': 'Number of participants and Rate of Postoperative complications', 'timeFrame': '1 year after the end of the operation', 'description': 'Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inguinal hernia', 'Mesh fixation', 'Titanium tacker'], 'conditions': ['Inguinal Hernia Unilateral']}, 'descriptionModule': {'briefSummary': 'Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation.\n\nObjective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use.\n\nPatients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 21 years\n* American Society of Anesthesiologists (ASA) physical status ≤ II\n* Patients with body mass index (BMI) of 25 to 35 kg/m²\n* Unilateral inguinal hernia\n\nExclusion Criteria:\n\n* Age \\< 21 years\n* ASA physical status \\> II\n* Patients with body mass index (BMI) \\> 35 kg/m²\n* Pregnant women\n* Bilateral inguinal hernia\n* Large inguinoscrotal hernia\n* Incarcerated hernia\n* Recurrent hernia\n* Strangulated hernia\n* Prostatic diseases\n* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases\n* Dysrhythmia\n* Hypertension\n* Ischemic heart disease\n* Hyperthyroidism\n* Liver or Renal impairment\n* Alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT05574751', 'briefTitle': 'Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Damanhour Teaching Hospital'}, 'officialTitle': 'Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use', 'orgStudyIdInfo': {'id': 'DTH: 22002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Titanium tacker group (n=30)', 'description': 'Group A', 'interventionNames': ['Other: Titanium tacker']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polypropylene group (n=30)', 'description': 'Group B', 'interventionNames': ['Other: Polypropylene 0']}], 'interventions': [{'name': 'Titanium tacker', 'type': 'OTHER', 'description': 'Mesh fixation with Titanium tacker', 'armGroupLabels': ['Titanium tacker group (n=30)']}, {'name': 'Polypropylene 0', 'type': 'OTHER', 'description': 'Mesh was sutured and fixed with polypropylene 0', 'armGroupLabels': ['Polypropylene group (n=30)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'state': 'El-Beheira', 'country': 'Egypt', 'facility': 'Damanhour Teaching Hospital', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'overallOfficials': [{'name': 'Ahmed M Shaat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damanhour Teaching Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour Teaching Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}