Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-30 @ 5:05 AM
Study NCT ID:
NCT01727050
Status:
COMPLETED
Last Update Posted:
2012-11-20
First Post:
2012-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-16', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic pain', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Severity of acute pain', 'timeFrame': '1 week'}, {'measure': 'Morbidities', 'timeFrame': '30 day'}, {'measure': 'Recurrence rate', 'timeFrame': '6 month'}, {'measure': 'Quality of life assessment', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hernia']}, 'referencesModule': {'references': [{'pmid': '24045438', 'type': 'DERIVED', 'citation': 'Chan MS, Teoh AY, Chan KW, Tang YC, Ng EK, Leong HT. Randomized double-blinded prospective trial of fibrin sealant spray versus mechanical stapling in laparoscopic total extraperitoneal hernioplasty. Ann Surg. 2014 Mar;259(3):432-7. doi: 10.1097/SLA.0b013e3182a6c513.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for the repair of primary unilateral inguinal hernia. Previous studies showed that patients underwent TEP have less post-operative pain and earlier return to normal activities. However, chronic pain is still a major issue affecting quality of life after TEP with a reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for application of FS laparoscopically is now available which can achieve mesh fixation by using fewer amounts of FS.\n\nIn this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. The treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. Operative procedures and post-operative management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. Any complications related to the mesh and operation will also be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case TEP under general anaesthesia will be considered eligible.\n\nExclusion Criteria:\n\n* Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.'}, 'identificationModule': {'nctId': 'NCT01727050', 'briefTitle': 'Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty', 'orgStudyIdInfo': {'id': 'FSMSLH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical stapling', 'interventionNames': ['Device: Mechanical stapling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fibrin sealant spray', 'interventionNames': ['Device: Fibrin sealant spray']}], 'interventions': [{'name': 'Fibrin sealant spray', 'type': 'DEVICE', 'description': 'Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter', 'armGroupLabels': ['Fibrin sealant spray']}, {'name': 'Mechanical stapling', 'type': 'DEVICE', 'description': 'Fixation of mesh would be performed using mechanical staplers', 'armGroupLabels': ['Mechanical stapling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Surgery, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Assistant Professor', 'investigatorFullName': 'Anthony Teoh', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}