Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT01421602
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2011-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-25', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal Hernia', 'Self-fixating mesh', 'Progrip', 'Hernia Recurrence', 'Mesh, Surgical', 'Recurrence'], 'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'pmid': '19005611', 'type': 'RESULT', 'citation': 'Chastan P. Tension-free open hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia. 2009 Apr;13(2):137-42. doi: 10.1007/s10029-008-0451-4. Epub 2008 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal repair is feasible in the Philippine setting. It will result in a comparable recurrence rate as published for the traditional Lichtenstein approach.', 'detailedDescription': 'The specific aim of this study is to assess the feasibility of using a self fixating lightweight mesh in open inguinal hernia under both under regional and local anesthesia in the Philippines. The primary endpoint of which is to assess the recurrence rate at 2 years (with an interim analysis 1 year after the procedure). Secondary endpoints would be to gather data with regards to postoperative pain, post operative surgical complications, wound healing complications, operating factors (mesh deployment time, total operating time), hernia factors (type and size of inguinal hernia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Potential study subjects will be patients who are:\n\n18 - 80 years old; Has confirmed with the informed consent; Has a primary inguinal hernia (either unilateral or bilateral) which is reducible and amenable to local or regional hernia repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Informed consent\n* Primary inguinal hernia suitable for open inguinal repair\n* Reducible hernia\n\nExclusion Criteria:\n\n* Incarcerated non reducible hernias\n* Bleeding disorders\n* Patients below 18 (lower age limit) and above 80 (upper age limit) years old\n* Hernia defects of greater than 4 cm'}, 'identificationModule': {'nctId': 'NCT01421602', 'briefTitle': 'A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'De La Salle University Medical Center'}, 'officialTitle': 'A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia', 'orgStudyIdInfo': {'id': 'AKMRC-11-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '4114', 'city': 'Dasmariñas', 'state': 'Cavite', 'country': 'Philippines', 'facility': 'De La Salle University Medical Center', 'geoPoint': {'lat': 14.32944, 'lon': 120.93667}}], 'overallOfficials': [{'name': 'Michael M Lawenko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'De La Salle University Medical Center - Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'De La Salle University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Michael M. Lawenko MD, FPCS', 'investigatorAffiliation': 'De La Salle University Medical Center'}}}}