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National Polish Registry of Minimally Invasive Liver Surgery (PL-MILS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05516394
Recruitment Status : Recruiting
First Posted : August 25, 2022
Last Update Posted : August 25, 2022
Sponsor:
Collaborators:
Jagiellonian University
Ludwik Rydygier Memorial Hospital, Cracow, Poland
Regional Oncology Center, Białystok, Poland
Medical University of Lublin
Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland
Medical University of Łódź
Information provided by (Responsible Party):
Wacław Hołówko, Medical University of Warsaw

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.

Primary 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.

The 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.

This study will be the first national report about diffusion of minimally invasive surgery in Poland.


Condition or disease Intervention/treatment
Liver Tumor Procedure: Laparoscopic liver resection

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: National Polish Registry of Minimally Invasive Liver Surgery
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Intervention Details:
  • Procedure: Laparoscopic liver resection
    Liver tumors are resected with minimally invasive approach, laparoscopically.

Outcome Measures
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Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 90 days ]
    Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system


Secondary Outcome Measures :
  1. Patient survival [ Time Frame: 5 years ]
  2. Postoperative hospital stay [ Time Frame: 1 year ]
  3. Number of patients scheduled for reoperation after laparoscopic liver resection [ Time Frame: 30 days ]
  4. Number of patients readmitted to hospital after discharge [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent laparoscopic liver resection in Poland
Criteria

Inclusion Criteria:

  • age >18 years
  • underwent laparoscopic liver resection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516394


Contacts
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Contact: Wacław Hołówko 0048667667044 waclaw.holowko@wum.edu.pl

Locations
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Poland
Department of General, Transplant and Liver Surgery, Medical University of Warsaw Recruiting
Warsaw, Poland
Contact: Wacław Hołówko    0048667667044    waclaw.holowko@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw
Jagiellonian University
Ludwik Rydygier Memorial Hospital, Cracow, Poland
Regional Oncology Center, Białystok, Poland
Medical University of Lublin
Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland
Medical University of Łódź
Investigators
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Principal Investigator: Wacław Hołówko Medical University of Warsaw
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Wacław Hołówko, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT05516394    
Other Study ID Numbers: AKBE/71/2020
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wacław Hołówko, Medical University of Warsaw:
laparoscopic liver resection
short-term results
long-term results
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases