Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:43 AM
Study NCT ID:
NCT07461558
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D010166', 'term': 'Palliative Care'}], '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'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We will enroll all adult patients with a unilateral symptomatic inguinal hernia who are suitable for a minimally invasive inguinal hernia repair. Once in the operating room and pneumoperitoneum is established, patients identified to have an occult contralateral inguinal hernia will be kept in the study. Those patients consented but without an occult inguinal hernia will be removed from the study at that point and considered screen failures.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day (±15) post-operative quality of life', 'timeFrame': '30 days postoperatively', 'description': 'At 30 days postoperatively, patients will see their operating surgeon and will undergo a physical exam and complete a EuraHS survey as is standard of care. The EuraHS Quality of Life Score, validated for inguinal hernia patients, allows quantification of pain, physical restriction, and cosmetic satisfaction-domains directly affected by surgical intervention.'}], 'secondaryOutcomes': [{'measure': 'Rate of occult hernias that require repair as well as occult hernia related emergencies.', 'timeFrame': '2 years', 'description': 'The researchers will assess the rate of occult hernias that require repair as well as occult hernia related emergencies (incarceration, strangulation or obstruction) in the watchful waiting group over the 2 year follow-up period.'}, {'measure': 'Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years.', 'timeFrame': '2 years', 'description': 'At 1 and 2 years patients will see their operating surgeon and will undergo a physical exam and EuraHS survey as is standard of care.'}, {'measure': 'Difference in rate of wound complications at 30-days (±15) following surgery.', 'timeFrame': '30-days', 'description': 'Wound events are defined as surgical site infection (SSI), surgical site occurrence (SSO) and surgical site occurrence requiring procedural intervention (SSOPI), as defined by the Ventral Hernia Working Group. Wound events will be assessed by physical exam or virtual evaluation at 30 (± 15) days.'}, {'measure': 'Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years.', 'timeFrame': '2 years', 'description': 'We will collect rate of readmissions and the cause for readmission as well as any medical complications and reasons for reoperation.'}, {'measure': 'Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days.', 'timeFrame': '30 days', 'description': 'At the 30-day follow-up appointment, the researchers will collect number and dose of opioids prescribed as well at opioids consumed in the last 30-days.'}, {'measure': 'Evaluate difference in inguinal hernia recurrence at 1and 2 years following surgery.', 'timeFrame': '2 years', 'description': 'Hernia recurrence will be determined using the current consensus score. This includes an algorithm previously described involving evaluation of CT scan, clinical exam, and Ventral Hernia Recurrence Inventory, a validated questionnaire using patient-reported outcomes to determine hernia recurrence after repair.'}, {'measure': 'Evaluate chronic groin pain at 1 and 2 years using the pain domain of the EuraHS score.', 'timeFrame': '2 years', 'description': 'Pain scores from the EuraHS will be collected at 1 and 2 years. These scores will be extrapolated to determine on-going pain suggestive of chronic groin pain.'}, {'measure': 'Perform a formal cost effectiveness analysis utilizing incremental cost effectiveness ratios.', 'timeFrame': '2 years', 'description': "Costs will be compared as continuous variables using a student's t-test. Cost data will be obtained from Northwestern and will include direct costs. Direct costs for the index operation will include operating room supply and time, anesthesia, and pharmacy."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Occult inguinal hernia', 'Asymptomatic inguinal hernia', 'Minimally invasive inguinal hernia repair', 'Transabdominal preperitoneal inguinal hernia repair'], 'conditions': ['Inguinal Hernia Bilateral', 'Inguinal Hernia Unilateral']}, 'referencesModule': {'references': [{'pmid': '37171090', 'type': 'BACKGROUND', 'citation': 'Shukla P, Huang LC, Zhao A, Sharew B, Miller B, Beffa L, Petro CC, Krpata DM, Prabhu AS, Rosen MJ. Determining the Minimum Clinically Important Difference for the European Hernia Society Quality of Life Instrument in Inguinal Hernia Repair Patients. J Am Coll Surg. 2023 Sep 1;237(3):525-532. doi: 10.1097/XCS.0000000000000754. Epub 2023 May 12.'}, {'pmid': '40789772', 'type': 'BACKGROUND', 'citation': 'Lewis SA, Huang LC, Al-Mansour MR. Quality of life outcomes of minimally invasive repair of occult contralateral inguinal hernias: an ACHQC analysis. Surg Endosc. 2025 Oct;39(10):6793-6801. doi: 10.1007/s00464-025-12060-1. Epub 2025 Aug 11.'}, {'pmid': '24022443', 'type': 'BACKGROUND', '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': '16418463', 'type': 'BACKGROUND', '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': '11178762', 'type': 'BACKGROUND', 'citation': 'Thumbe VK, Evans DS. To repair or not to repair incidental defects found on laparoscopic repair of groin hernia: early results of a randomized control trial. Surg Endosc. 2001 Jan;15(1):47-9. doi: 10.1007/s004640000254.'}, {'pmid': '39190257', 'type': 'BACKGROUND', 'citation': 'Remulla D, Al-Mansour MR, Schneider C, Phillips S, Hope WW, Bradley Iii JF, Pierce RA, Arias-Espinosa L, Bernardi K, Holihan JL, Loor M, Liang MK, Miller BT. Research prioritization in hernia surgery: a modified Delphi ACHQC and VHOC expert consensus. Hernia. 2024 Dec;28(6):2217-2222. doi: 10.1007/s10029-024-03139-0. Epub 2024 Aug 27.'}, {'pmid': '33688950', 'type': 'BACKGROUND', 'citation': 'Dhanani NH, Olavarria OA, Wootton S, Petsalis M, Lyons NB, Ko TC, Kao LS, Liang MK. Contralateral exploration and repair of occult inguinal hernias during laparoscopic inguinal hernia repair: systematic review and Markov decision process. BJS Open. 2021 Mar 5;5(2):zraa020. doi: 10.1093/bjsopen/zraa020.'}, {'pmid': '23708722', 'type': 'BACKGROUND', 'citation': 'van den Heuvel B, Beudeker N, van den Broek J, Bogte A, Dwars BJ. The incidence and natural course of occult inguinal hernias during TAPP repair: repair is beneficial. Surg Endosc. 2013 Nov;27(11):4142-6. doi: 10.1007/s00464-013-3008-2. Epub 2013 May 25.'}, {'pmid': '29330835', 'type': 'BACKGROUND', 'citation': 'HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.'}, {'pmid': '14615114', 'type': 'BACKGROUND', 'citation': 'Kingsnorth A, LeBlanc K. Hernias: inguinal and incisional. Lancet. 2003 Nov 8;362(9395):1561-71. doi: 10.1016/S0140-6736(03)14746-0.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare two ways of managing a small, hidden hernia that can sometimes be found during minimally invasive surgery to repair a hernia on one side of the groin. Occasionally while fixing the known hernia, the surgeon discovers a small hernia on the other side that has not caused any symptoms. Surgeons do not agree on the best way to handle these hernias. Some believe it should be repaired right away during the same operation to prevent it from getting bigger or from causing symptoms later, which could require another surgery. Others believe it is better to leave it alone since it is not causing problems and groin hernia surgery carries risks including long-term pain.\n\nThis study will randomly assign patients, if a hidden hernia is found during surgery, to either having it repaired immediately or to have it monitored over time. Patients will be followed up at 30 days, 1 year and 2 years following surgery. The researchers will compare recovery and quality of life between the two groups. For those in the monitoring group, the study will also track whether the hidden hernia causes symptoms or eventually needs surgery. The goal is to determine whether repairing the hidden hernia right away is as safe and effective as watching and waiting, so doctors and patients can make more informed decisions in the future.', 'detailedDescription': 'This is a multicenter randomized controlled trial evaluating two management strategies - watchful waiting versus immediate repair - for occult contralateral inguinal hernias discovered during minimally invasive unilateral inguinal hernia repair. The management of occult inguinal hernias discovered at the time of laparoscopic inguinal hernia repair remains controversial. Many surgeons advocate for immediate repair during the index operation as this prevents reoperation as patients risk hernia progression and developing symptoms in the future. Others refrain from repair given that this occult hernia is asymptomatic and does not justify the risk of complications, including chronic pain, associated with repair. Currently there is no level 1 evidence to guide decision making for immediate repair versus watchful waiting. We plan to conduct at randomized, multi-center, non-inferiority trial to establish if immediate repair is non-inferior to watchful waiting in short term 30-day quality of life. Patients will be randomized intraoperatively once an occult contralateral inguinal hernia is identified. Patients will be followed up at 30-day, 1 and 2 years. In the watchful waiting group, occult hernia-related complications and those requiring repair will be captured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients ≥18 years old\n* Symptomatic unilateral inguinal hernia\n* Occult contralateral hernia identified intraoperatively\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Prior contralateral inguinal hernia repair\n* Symptomatic, bilateral inguinal hernias confirmed on physical exam\n* Contraindications to general anesthesia or surgery\n* Urgent or emergent presentations\n* Adults unable to consent\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT07461558', 'acronym': 'WATCH IT', 'briefTitle': 'Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'WATCH IT TRIAL WAtchful Waiting Versus immediaTe Repair for Occult Contralateral Hernias Found During MIS Inguinal Hernia Repair Trial.', 'orgStudyIdInfo': {'id': 'STU00225342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate occult hernia repair group', 'description': 'Patients who are randomized to immediate occult hernia repair will undergo TAPP hernia repair with mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.', 'interventionNames': ['Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Watchful waiting occult hernia group', 'description': 'Patients randomized to the watchful waiting group will undergo standard transabdominal preperitoneal inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone.', 'interventionNames': ['Procedure: Watchful waiting with supportive care']}], 'interventions': [{'name': 'surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines', 'type': 'PROCEDURE', 'description': 'Patients in the immediate occult hernia repair arm will under TAPP repair with placement of mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.', 'armGroupLabels': ['Immediate occult hernia repair group']}, {'name': 'Watchful waiting with supportive care', 'type': 'PROCEDURE', 'description': 'Patients in the watchful waiting group will undergo standard TAPP inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone. These patients will be followed postoperatively for occult hernia related emergencies including incarceration, strangulation or obstruction.', 'armGroupLabels': ['Watchful waiting occult hernia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Melland-Smith, MD', 'role': 'CONTACT', 'email': 'megan.mellandsmith@nm.org', 'phone': '3129071414'}, {'name': 'Nancy Ly, MD', 'role': 'CONTACT', 'email': 'nancy.ly@nm.org', 'phone': '2624551560'}], 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Megan S Melland-Smith, MD', 'role': 'CONTACT', 'email': 'megan.mellandsmith@nm.org', 'phone': '3129071414'}], 'overallOfficials': [{'name': 'Nancy Ly, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be publicly shared. De-identified data may be available from the study investigators upon reasonable request and with appropriate institutional approvals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Megan Melland-Smith', 'investigatorAffiliation': 'Northwestern University'}}}}