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

Fondazione Poliambulanza Istituto Ospedaliero

Status: Completed

Conditions: Obesity; Liver Metastases; Liver Cancer

Treatments: Procedure: Minimally invasive liver resection

Study type: Observational

Funder types: Other

Identifiers

NCT05475054

NP5469

Details and patient eligibility

About

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.

Enrollment: 9,963 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years and older
• Patients that have undergone an elective minimally invasive or open liver resection

Exclusion criteria

• Patients that have undergone a hand-assisted or robotic procedure
• Patients with a BMI lower than 18.5

Trial design

9,963 participants in 2 patient groups

Open liver resection

Description:

Non-obese or obese patients that underwent an open liver resection for all indications

Minimally invasive liver resection

Description:

Non-obese or obese patients that underwent a minimally invasive liver resection for all indications

Treatment:

Procedure: Minimally invasive liver resection