Clinical Trials Directory

Trials / Completed

CompletedNCT05475054

Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes

Indications, Trends, and Perioperative Outcomes of Minimally Invasive and Open Liver Surgery in Non-obese and Obese Patients: an International Multicentre Propensity Score Matched Retrospective Cohort Study of 9963 Patients.

Status
Completed
Phase
Study type
Observational
Enrollment
9,963 (actual)
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Despite the worldwide increase of both obesity and use of minimally invasive liver surgery(MILS), evidence regarding the safety and eventual benefits of MILS in obese patients is scarce. The aim of this study is therefore to compare the outcomes of non-obese and obese patients(BMI 18.5-29.9 and BMI≥30, respectively) undergoing MILS and OLS, and to assess trends in MILS use among obese patients. In this retrospective cohort study, patients operated at 20 hospitals in eight countries(2009-2019) will be included and the characteristics and outcomes of non-obese and obese patients will be compared. Thereafter, the outcomes of MILS and OLS were compared in both groups after propensity-score matching(PSM). Changes in the adoption of MILS during the study period will be investigated.

Conditions

Interventions

TypeNameDescription
PROCEDUREMinimally invasive liver resectionA liver resection performed by minimally invasive (keyhole) surgery

Timeline

Start date
2020-12-01
Primary completion
2022-07-18
Completion
2022-07-22
First posted
2022-07-26
Last updated
2023-02-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05475054. Inclusion in this directory is not an endorsement.