Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-29 @ 9:23 PM
Study NCT ID:
NCT01141335
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2010-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-20', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-hernioplasty acute pain', 'timeFrame': '24 hours', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}], 'secondaryOutcomes': [{'measure': 'physical function', 'timeFrame': '24 hours', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'postoperative acute discomfort', 'timeFrame': '24 hours', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'wound infection', 'timeFrame': '7 days', 'description': 'to rate the wound infection risk.'}, {'measure': 'postoperative complication', 'timeFrame': 'from 24 hours to 5 years', 'description': 'to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.'}, {'measure': 'recurrence', 'timeFrame': 'from 1 months to 5 years', 'description': 'to measure the recurrence'}, {'measure': 'mesh shrinkage', 'timeFrame': '14 days', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'post-hernioplasty acute pain', 'timeFrame': '72 hours', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty acute pain', 'timeFrame': '7 days', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty acute pain', 'timeFrame': '14 days', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '1 months', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '3 months', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '6 months', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '1 year', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '2 years', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '3 years', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '4 years', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'post-hernioplasty chronic pain', 'timeFrame': '5 years', 'description': 'to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups'}, {'measure': 'physical function', 'timeFrame': '72 hours', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '7 days', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '14 days', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '1 months', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '3 months', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '6 months', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '1 year', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '2 years', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '3 years', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '4 years', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'physical function', 'timeFrame': '5 years', 'description': 'to measure the physical function score from the SF-36 questionnaire'}, {'measure': 'postoperative acute discomfort', 'timeFrame': '72 hours', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative acute discomfort', 'timeFrame': '14 days', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '1 months', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '3 months', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '6 months', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '1 year', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '2 years', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '3 years', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '4 years', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative chronic discomfort', 'timeFrame': '5 years', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'postoperative acute and chronic discomfort', 'timeFrame': '7 days', 'description': 'to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).'}, {'measure': 'wound infection', 'timeFrame': '14 days', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '1 months', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '3 months', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '6 months', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '1 year', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '2 years', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '3 years', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '4 years', 'description': 'to rate the wound infection risk.'}, {'measure': 'wound infection', 'timeFrame': '5 years', 'description': 'to rate the wound infection risk.'}, {'measure': 'mesh shrinkage', 'timeFrame': '1 months', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '3 months', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '6 months', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '1 years', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '2 years', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '3 years', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '4 years', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}, {'measure': 'mesh shrinkage', 'timeFrame': '5 years', 'description': 'to measure the effectiveness shrinkage of the two different mesh using Ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['shrinkage', 'postoperative pain and discomfort'], 'conditions': ['Physical Function', 'Pain', 'Hernia', 'Wound Infection', 'Postoperative Complication', 'Recurrence']}, 'descriptionModule': {'briefSummary': "To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\>18 \\<65 years of age\n* Diagnosis of Unilateral inguinal hernia\n* Able to provide written consent\n* BMI \\< 35\n* ASA I-II patients\n* Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty\n* Informed consent\n\nExclusion Criteria:\n\n* Recurrent hernias\n* Incarcerated hernia\n* BMI \\> 35\n* ASA III-IV patients\n* Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)\n* Hypersensitivity to any drug in study\n* Patients with an intra-operative findings of different pathology will be excluded from the study"}, 'identificationModule': {'nctId': 'NCT01141335', 'briefTitle': 'Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': "Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial", 'orgStudyIdInfo': {'id': 'DS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTFE mesh', 'description': 'A Lichtenstein tension-free hernioplasty is performed using PTFE mesh', 'interventionNames': ['Device: Infinit® PTFE mesh (WL Gore)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'polypropylene mesh', 'description': 'A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh', 'interventionNames': ['Device: polypropylene mesh']}], 'interventions': [{'name': 'polypropylene mesh', 'type': 'DEVICE', 'description': 'A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.', 'armGroupLabels': ['polypropylene mesh']}, {'name': 'Infinit® PTFE mesh (WL Gore)', 'type': 'DEVICE', 'description': 'A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.', 'armGroupLabels': ['PTFE mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00189', 'city': 'Rome', 'state': 'Italy', 'country': 'Italy', 'facility': "UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Luigi Masoni, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': "Azienda Ospedaliera Sant'Andrea, Rome, Italy"}, {'name': 'Francesco Saverio Mari, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Azienda Ospedaliera Sant'Andrea, Rome, Italy"}, {'name': 'Antonio Brescia, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Azienda Ospedaliera Sant'Andrea, Rome, Italy"}, {'name': 'Giuseppe R Nigri, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Azienda Ospedaliera Sant'Andrea, Rome, Italy"}, {'name': 'Francesco Favi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Azienda Ospedaliera Sant'Andrea, Rome, Italy"}, {'name': 'Andrea Milillo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Azienda Ospedaliera Sant'Andrea, Rome, Italy"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Francesco Saverio Mari', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}