Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 3:59 AM
Study NCT ID:
NCT01421550
Status:
UNKNOWN
Last Update Posted:
2011-08-23
First Post:
2011-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006554', 'term': 'Hernia, Umbilical'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D001201', 'term': 'Ascites'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D014945', 'term': 'Wound Healing'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-22', 'studyFirstSubmitDate': '2011-08-19', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications', 'timeFrame': '2 years', 'description': 'The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '2 years'}, {'measure': 'Mortality', 'timeFrame': '2 years'}, {'measure': 'Length of hospital stay', 'timeFrame': '3 months'}, {'measure': 'Quality of life', 'timeFrame': '2 years'}, {'measure': 'Cost effectiveness', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['umbilical', 'hernia', 'cirrhosis', 'ascites', 'conservative', 'surgery', 'optimal management'], 'conditions': ['Umbilical Hernia', 'Liver Cirrhosis', 'Ascites']}, 'referencesModule': {'references': [{'pmid': '33237442', 'type': 'DERIVED', 'citation': 'de Goede B, van Rooijen MMJ, van Kempen BJH, Polak WG, de Man RA, Taimr P, Lange JF, Metselaar HJ, Kazemier G. Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial). Langenbecks Arch Surg. 2021 Feb;406(1):219-225. doi: 10.1007/s00423-020-02033-4. Epub 2020 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates.\n\nThe aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Umbilical hernia\n* Liver cirrhosis\n* Ascites (US proven)\n* Age ≥ 18 years\n* Signed Informed consent\n\nExclusion Criteria:\n\n* Recurrent umbilical hernia\n* Midline laparotomy in medical history\n* ASA1 score IV or above\n* Incarcerated hernia related emergency procedures\n* Patent umbilical vein; \\>5mm\n* Expected time to Ltx \\<3 months'}, 'identificationModule': {'nctId': 'NCT01421550', 'acronym': 'CRUCIAL', 'briefTitle': 'Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CRUCIAL trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment', 'description': 'Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.', 'interventionNames': ['Procedure: Conservative treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical repair', 'description': 'Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.', 'interventionNames': ['Procedure: Surgical repair']}], 'interventions': [{'name': 'Conservative treatment', 'type': 'PROCEDURE', 'description': 'Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.', 'armGroupLabels': ['Conservative treatment']}, {'name': 'Surgical repair', 'type': 'PROCEDURE', 'description': 'Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.', 'armGroupLabels': ['Surgical repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015CE', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'B. de Goede, Msc', 'role': 'CONTACT'}, {'name': 'H.H. Eker, MD', 'role': 'CONTACT'}, {'name': 'G. Kazemier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'B. de Goede, Msc', 'role': 'CONTACT', 'email': 'b.degoede@erasmusmc.nl', 'phone': '+31 6280661102'}, {'name': 'H.H. Eker, MD', 'role': 'CONTACT', 'email': 'h.eker@erasmusmc.nl', 'phone': '+31 628925554'}], 'overallOfficials': [{'name': 'G Kazemier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}, {'name': 'J.F. Lange, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. G. Kazemier', 'investigatorFullName': 'hasan eker', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}