NCT05475054

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,963

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

July 22, 2022

Last Update Submit

February 14, 2023

Conditions

Liver CancerLiver MetastasesObesity

Keywords

overweightfatty liveropen liver resectionlaparoscopic liver resectionminimally invasive liver resection

Outcome Measures

Primary Outcomes (1)

  • Major complications

    Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure

    30 days postoperatively

Secondary Outcomes (13)

  • Overall complications

    30 days postoperatively

  • Length of hospital stay

    30 days postoperatively

  • R0 resection margin

    30 days postoperatively

  • Intraoperative blood loss

    During the surgical procedure

  • Operative time

    During the surgical procedure

  • +8 more secondary outcomes

Study Arms (2)

Open liver resection

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

Minimally invasive liver resection

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

Procedure: Minimally invasive liver resection

Interventions

Minimally invasive liver resectionPROCEDURE

A liver resection performed by minimally invasive (keyhole) surgery

Also known as: Laparoscopic liver resection
Minimally invasive liver resection

Eligibility Criteria

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

Adult patients who underwent an elective liver resection at 20 hepatobiliary referral centres between January 2009 and December 2019

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

MeSH Terms

Conditions

Liver NeoplasmsObesityOverweightFatty Liver

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

December 1, 2020

Primary Completion

July 18, 2022

Study Completion

July 22, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

IT(1)