Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT05516394
Status:
RECRUITING
Last Update Posted:
2022-08-25
First Post:
2022-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Polish Registry of Minimally Invasive Liver Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '90 days', 'description': 'Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system'}], 'secondaryOutcomes': [{'measure': 'Patient survival', 'timeFrame': '5 years'}, {'measure': 'Postoperative hospital stay', 'timeFrame': '1 year'}, {'measure': 'Number of patients scheduled for reoperation after laparoscopic liver resection', 'timeFrame': '30 days'}, {'measure': 'Number of patients readmitted to hospital after discharge', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic liver resection', 'short-term results', 'long-term results'], 'conditions': ['Liver Tumor']}, 'referencesModule': {'references': [{'pmid': '37816169', 'type': 'DERIVED', 'citation': 'Holowko W, Serednicki W, Bartkowiak M, Wysocki M, Domurat M, Mielko J, Pierscinski S, Hogendorf P, Masior L, Kalinowski P, Wierdak M, Fraczek M, Tarasik A, Wroblewski T, Budzynski A, Pedziwiatr M, Grat M. Early adoption of laparoscopic liver surgery in Poland: a national retrospective cohort study. Int J Surg. 2024 Jan 1;110(1):361-371. doi: 10.1097/JS9.0000000000000840.'}]}, 'descriptionModule': {'briefSummary': 'After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Successively more countries follow laparoscopic liver pioneers and apply laparoscopic liver surgery for everyday practice.\n\nPrimary aim of the study is to assess the evolution and diffusion of minimally invasive liver surgery in Poland. Secondly, it will allow to assess the actual short- and long-term results of laparoscopic liver resections and compare it to the international benchmark values.\n\nThe National Polish Registry of Minimally Invasive Liver Surgery will include data about all cases of laparoscopic liver resections performed in Poland since the first case in 2010. All surgical departments, where laparoscopic liverresection is regularly performed, will be invited. Data of demography, previous medical history, preoperative assessment, intraoperative and postoperative period, histopathological findings and long-term follow-up will be included in the registry.\n\nThis study will be the first national report about diffusion of minimally invasive surgery in Poland.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent laparoscopic liver resection in Poland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* underwent laparoscopic liver resection'}, 'identificationModule': {'nctId': 'NCT05516394', 'acronym': 'PL-MILS', 'briefTitle': 'National Polish Registry of Minimally Invasive Liver Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'National Polish Registry of Minimally Invasive Liver Surgery', 'orgStudyIdInfo': {'id': 'AKBE/71/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic liver resection', 'type': 'PROCEDURE', 'description': 'Liver tumors are resected with minimally invasive approach, laparoscopically.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Wacław Hołówko', 'role': 'CONTACT', 'email': 'waclaw.holowko@wum.edu.pl', 'phone': '0048667667044'}], 'facility': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Wacław Hołówko', 'role': 'CONTACT', 'email': 'waclaw.holowko@wum.edu.pl', 'phone': '0048667667044'}], 'overallOfficials': [{'name': 'Wacław Hołówko', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jagiellonian University', 'class': 'OTHER'}, {'name': 'Ludwik Rydygier Memorial Hospital, Cracow, Poland', 'class': 'UNKNOWN'}, {'name': 'Regional Oncology Center, Białystok, Poland', 'class': 'UNKNOWN'}, {'name': 'Medical University of Lublin', 'class': 'OTHER'}, {'name': 'Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland', 'class': 'UNKNOWN'}, {'name': 'Medical University of Łódź', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wacław Hołówko', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}