Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections

NCT05224739 | Enrolling By Invitation

• 1 other identifier: 020.HPB.2021.D
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To validate the Iwate difficulty scoring system and Institut Mutualiste Montsouris (IMM) scoring system (Appendix 2) in both laparoscopic and robotic liver resections

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Iwate scores for laparoscopic and robotic liver resections

  To validate the Iwate difficulty scoring system IMM scoring system in both laparoscopic .and robotic liver resections. The IWATA measures the difficulty index from 0 to 12. The IMM scoring is from code 1 to 11.

  January 1, 2000 to December 31, 2020

Secondary Outcomes (1)

• Propensity scores for robotic and laparoscopic liver resections

  January 1, 2000 to December 31, 2020

Study Arms (1)

Patients who underwent MILR from January 1, 2000 to December 31, 2020

Hospital of patients who underwent MILR from January 1, 2000 to December 31, 2020.

Procedure: Minimally Invasive Liver Resection

Interventions

Minimally Invasive Liver Resection PROCEDURE

laparoscopic and robotic liver resections

Patients who underwent MILR from January 1, 2000 to December 31, 2020

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital of patients who underwent Minimally Invasive Liver Resection from January 1, 2000 to December 31, 2020.

You may qualify if:

• All consecutive patients operated at a single institution during a fixed period
• Most recent operation date allowed (up till December 31, 2020, to allow three months follow-up).
• All minimally invasive hepatectomy approaches can be included, including lap- assisted (hybrid), hand-assisted, robotic-assisted and pure laparoscopy.
• The data of all patients including those that had repeat liver resections, concomitant surgeries (e.g. colectomies, hilar lymph node dissection, enbloc resections) may be included
• Patients with no "liver tumors" such as recurrent pyogenic cholangitis/ gallbladder may be included
• The site of the "lesion/ pathology" will be considered as the tumor site, size will be considered less than 3 cm unless tumor invades the liver.

You may not qualify if:

• Patients \< 18 years of age
• Patients with liver transplant living donor hepatectomies

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Liver Institute of Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Alejandro Mejia, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 4, 2022
• Study Start: July 16, 2021
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)