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

August 24, 2022 updated by: Wacław Hołówko, Medical University of Warsaw

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of General, Transplant and Liver Surgery, Medical University of Warsaw
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent laparoscopic liver resection in Poland

Description

Inclusion Criteria:

  • age >18 years
  • underwent laparoscopic liver resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 90 days
Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient survival
Time Frame: 5 years
5 years
Postoperative hospital stay
Time Frame: 1 year
1 year
Number of patients scheduled for reoperation after laparoscopic liver resection
Time Frame: 30 days
30 days
Number of patients readmitted to hospital after discharge
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Jagiellonian University
Medical University of Lublin
Medical University of Łódź
Ludwik Rydygier Memorial Hospital, Cracow, Poland
Regional Oncology Center, Białystok, Poland
Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland

Investigators

  • Principal Investigator: Wacław Hołówko, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (ACTUAL)

August 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKBE/71/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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