NCT05516394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

August 1, 2022

Last Update Submit

August 24, 2022

Conditions

Liver Tumor

Keywords

laparoscopic liver resectionshort-term resultslong-term results

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system

    90 days

Secondary Outcomes (4)

  • Patient survival

    5 years

  • Postoperative hospital stay

    1 year

  • Number of patients scheduled for reoperation after laparoscopic liver resection

    30 days

  • Number of patients readmitted to hospital after discharge

    30 days

Interventions

Laparoscopic liver resectionPROCEDURE

Liver tumors are resected with minimally invasive approach, laparoscopically.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent laparoscopic liver resection in Poland

You may qualify if:

  • age \>18 years
  • underwent laparoscopic liver resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Warsaw, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37816169DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Wacław Hołówko

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wacław Hołówko

CONTACT

0048667667044waclaw.holowko@wum.edu.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 25, 2022

Study Start

July 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

PL(1)