Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-08 @ 4:38 AM
Study NCT ID:
NCT00263250
Status:
COMPLETED
Last Update Posted:
2013-07-01
First Post:
2005-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-08', 'releaseDate': '2016-02-10'}, {'resetDate': '2016-07-25', 'releaseDate': '2016-06-15'}, {'resetDate': '2017-08-03', 'releaseDate': '2017-04-25'}, {'resetDate': '2018-03-30', 'releaseDate': '2017-08-29'}], 'estimatedResultsFirstSubmitDate': '2016-02-10'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 724}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-28', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain limiting usual activities at two years.'}, {'measure': 'Physical function (PCS) at two years.'}], 'secondaryOutcomes': [{'measure': 'Complications'}, {'measure': 'patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.'}, {'measure': 'Cost effectiveness.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia', 'asymptomatic', 'watchful waiting', 'tension-free hernia repair'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '16418463', 'type': 'RESULT', 'citation': 'Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006 Jan 18;295(3):285-92. doi: 10.1001/jama.295.3.285.'}, {'pmid': '31327453', 'type': 'DERIVED', 'citation': 'Schroeder AD, Tubre DJ, Fitzgibbons RJ Jr. Watchful Waiting for Inguinal Hernia. Adv Surg. 2019 Sep;53:293-303. doi: 10.1016/j.yasu.2019.04.014. Epub 2019 May 15. No abstract available.'}, {'pmid': '25293603', 'type': 'DERIVED', 'citation': 'Ramanan B, Maloley BJ, Fitzgibbons RJ Jr. Inguinal hernia: follow or repair? Adv Surg. 2014;48:1-11. doi: 10.1016/j.yasu.2014.05.017.'}, {'pmid': '24022443', 'type': 'DERIVED', 'citation': 'Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.'}, {'pmid': '21239979', 'type': 'DERIVED', 'citation': "Sarosi GA, Wei Y, Gibbs JO, Reda DJ, McCarthy M, Fitzgibbons RJ, Barkun JS. A clinician's guide to patient selection for watchful waiting management of inguinal hernia. Ann Surg. 2011 Mar;253(3):605-10. doi: 10.1097/SLA.0b013e31820b04e9."}], 'seeAlsoLinks': [{'url': 'http://www.facs.org', 'label': 'American College of Surgeons'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter clinical trial to compare pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation, or a standard hernia repair with mesh. We studied the safety of delaying operation.', 'detailedDescription': 'CONTEXT Many men with an inguinal hernia have minimal symptoms. Whether deferring operation is safe and a good option for some patients has not been assessed.\n\nOBJECTIVE To compare pain and the Physical Component Score (PCS) of the SF-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting (WW) or a standard tension-free hernia repair (TFR).\n\nDESIGN, SETTING, AND PATIENTS. Between January, 1999 and December, 2004 we conducted a multicenter trial of 720 men (364 WW, 356 TFR) who were followed for 2-4.5 years. Men were excluded with hernia pain interfering with activities; undetectable hernias; infection; American Society of Anesthesiologists Physical Status \\>3; recent difficulty in reducing the hernia.\n\nINTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for hernia symptoms. Men assigned to operation received TFR, and were followed at 3 and 6 months, and annually.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: men 18 years of age and older with asymptomatic or minimally symptomatic inguinal hernias who give informed consent to be randomized.\n\n\\-\n\nExclusion Criteria:Presence of pain limiting usual activities, difficulty in reducing hernia within last 6 weeks, undetectable hernias, local or systemic infection, ASA physical status \\>3, or participation in another clinical trial.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00263250', 'briefTitle': 'Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men', 'orgStudyIdInfo': {'id': 'R01HS009860', 'link': 'https://reporter.nih.gov/quickSearch/R01HS009860', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'watchful waiting or tension-free hernia repair', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'American College of Surgeons', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Olga Jonasson, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American College of Surgeons'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-10', 'type': 'RELEASE'}, {'date': '2016-03-08', 'type': 'RESET'}, {'date': '2016-06-15', 'type': 'RELEASE'}, {'date': '2016-07-25', 'type': 'RESET'}, {'date': '2017-04-25', 'type': 'RELEASE'}, {'date': '2017-08-03', 'type': 'RESET'}, {'date': '2017-08-29', 'type': 'RELEASE'}, {'date': '2018-03-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Creighton University'}}}}