The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date August 1, 2022
First Posted Date August 25, 2022
Last Update Posted Date August 25, 2022
Actual Study Start Date July 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2022)		 Postoperative complications [ Time Frame: 90 days ]
Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 24, 2022)
  • Patient survival [ Time Frame: 5 years ]
  • Postoperative hospital stay [ Time Frame: 1 year ]
  • Number of patients scheduled for reoperation after laparoscopic liver resection [ Time Frame: 30 days ]
  • Number of patients readmitted to hospital after discharge [ Time Frame: 30 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Polish Registry of Minimally Invasive Liver Surgery
Official Title National Polish Registry of Minimally Invasive Liver Surgery
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who underwent laparoscopic liver resection in Poland
Condition Liver Tumor
Intervention Procedure: Laparoscopic liver resection
Liver tumors are resected with minimally invasive approach, laparoscopically.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 24, 2022)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age >18 years
  • underwent laparoscopic liver resection
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wacław Hołówko 0048667667044 waclaw.holowko@wum.edu.pl
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT05516394
Other Study ID Numbers AKBE/71/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Wacław Hołówko, Medical University of Warsaw
Original Responsible Party Same as current
Current Study Sponsor Medical University of Warsaw
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Wacław Hołówko Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date August 2022