Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT00311935
Status:
UNKNOWN
Last Update Posted:
2009-02-03
First Post:
2006-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-02', 'studyFirstSubmitDate': '2006-04-05', 'studyFirstSubmitQcDate': '2006-04-05', 'lastUpdatePostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia recurrence rates at 2 years post surgery.'}], 'secondaryOutcomes': [{'measure': 'Complication rates.'}, {'measure': 'Duration of procedure.'}, {'measure': 'Cost of equipment use.'}, {'measure': 'Rate of conversion to open procedure'}, {'measure': 'Length of hospital stay.'}, {'measure': 'Time to return to work and usual activities.'}, {'measure': 'Pain scores and analgesic use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hernia', 'Inguinal', 'Groin', 'Laparoscopic', 'Open', 'Abdominal wall'], 'conditions': ['Hernia, Inguinal']}, 'descriptionModule': {'briefSummary': 'This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.', 'detailedDescription': 'Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.\n\nPhone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.\n\nPrimary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.\n\nQuality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.\n\nPain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.\n\nCost analysis to include the following parameters: theatre equipment costs, theatre time, drug use, hospital stay, time to return to work, time to return to normal activities.\n\nInterim analysis at 2 years of followup by independent Health and Safety committee. Final analysis at 4 years of followup.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male \\<60yrs with primary inguinal hernia\n\nExclusion Criteria:\n\n* Recurrent hernia\n* Bilateral hernia\n* Non-reducible/obstructed hernia\n* Previous lower abdominal surgery/radiotherapy'}, 'identificationModule': {'nctId': 'NCT00311935', 'briefTitle': 'Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Waitemata District Health Board'}, 'officialTitle': 'Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60', 'orgStudyIdInfo': {'id': 'Hernia repair study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'method of hernia repair', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'facility': 'Waitemata District Health Board', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'centralContacts': [{'name': 'Michael Rodgers, MBCHB, FRACS', 'role': 'CONTACT', 'email': 'michael.rodgers@waitematadhb.govt.nz', 'phone': '+64 9 486 8920', 'phoneExt': '3152'}, {'name': 'Hisham Hammodat, MBCHB, FRACS', 'role': 'CONTACT', 'email': 'hisham.hammodat@waitematadhb.govt.nz', 'phone': '+64 9 486 8920', 'phoneExt': '2459'}], 'overallOfficials': [{'name': 'Michael Rodgers, MBCHB,FRACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Waitemata District Health Board'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Waitemata District Health Board', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tyco Healthcare Group', 'class': 'INDUSTRY'}]}}}