Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04988958
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004443', 'term': 'Echinococcosis'}], 'ancestors': [{'id': 'D002590', 'term': 'Cestode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 914}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-23', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-23', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of hydatic cyst', 'timeFrame': '2 years', 'description': 'recurrence of hydatid cyst after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hydatid Cyst']}, 'descriptionModule': {'briefSummary': 'The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).', 'detailedDescription': 'The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).\n\nData from all patients with LHC treated in Sahloul Hospital, between January 2000 and December 2019, were retrieved from a retrospective database. To minimize selection bias, propensity score matching (PSM) was performed, based on variables representing patient characteristics and operative risk factors.\n\nRS especially total pericystectomy had fewer postoperative complications and lower recurrence rate compared to CS. RS may be the preferred procedure for LHC if the expertise is available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '914 Patients , who underwent surgical treatment at the Department of General and Digestive Surgery, Sahloul University Hospital Center, Sousse, Tunisia from 1st January 2000 to 31st December 2019 was performed. The diagnosis of LHC was established by clinical history, physical examination and abdominal ultrasonography (USG) in all patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 14 years old.\n* Patients presenting liver hydatid cyst .\n\nExclusion Criteria:\n\n* age less than 14 years old.\n* Patients presenting other localization of hydtic cyst , than the liver.\n* calcified cysts.\n* patients with incomplete medical records.\n* patients who were lost to follow up.'}, 'identificationModule': {'nctId': 'NCT04988958', 'briefTitle': 'Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sousse'}, 'officialTitle': 'Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts: A Propensity Score Matching Analysis', 'orgStudyIdInfo': {'id': 'U23477'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hydatid cyst resection', 'type': 'PROCEDURE', 'description': 'radical resection of hydatic cyst'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sousse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'ammar houssem', 'investigatorAffiliation': 'Université de Sousse'}}}}