Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05475054
Acronym
MILSOBES
Enrollment
9963
Registered
2022-07-26
Start date
2020-12-01
Completion date
2022-07-22
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Liver Metastases, Obesity

Keywords

overweight, fatty liver, open liver resection, laparoscopic liver resection, minimally invasive liver resection

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.

Interventions

A liver resection performed by minimally invasive (keyhole) surgery

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
The Queen Elizabeth Hospital
CollaboratorOTHER
Umberto I Mauriziano Hospital, Turin, Italy
CollaboratorUNKNOWN
Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway
CollaboratorUNKNOWN
Padua University Hospital, Padua, Italy
CollaboratorUNKNOWN
IRCCS San Raffaele
CollaboratorOTHER
University Hospital of Girona Dr. Josep Trueta
CollaboratorNETWORK
Clinica Universidad de Navarra, Pamplona, Spain
CollaboratorUNKNOWN
Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France
CollaboratorUNKNOWN
Groeninge Hospital, Kortrijk, Belgium
CollaboratorUNKNOWN
University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
CollaboratorUNKNOWN
Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy
CollaboratorUNKNOWN
University of Verona, Verona, Italy
CollaboratorUNKNOWN
Virginia Mason Medical Center, Seattle, USA
CollaboratorUNKNOWN
University of California San Francisco, California, USA
CollaboratorUNKNOWN
Moscow Clinical Research Centre, Moscow, Russia
CollaboratorUNKNOWN
Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy
CollaboratorUNKNOWN
Antoine Béclère Hospital, Paris, France
CollaboratorUNKNOWN
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
University of Modena and Reggio Emilia
CollaboratorOTHER
Fondazione Poliambulanza Istituto Ospedaliero
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major complications30 days postoperativelySevere complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure

Secondary

MeasureTime frameDescription
Length of hospital stay30 days postoperativelyThe length of hospital stay for the surgical procedure
R0 resection margin30 days postoperativelyProportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed. Proportion of patients in whom a microscopically radical resection was performed
Intraoperative blood lossDuring the surgical procedureIntraoperative blood loss in milliliters
Operative timeDuring the surgical procedureOperative time in minutes
Conversion to open surgeryDuring the surgical procedureIntra-operative conversion to an open or hand-assisted procedure in the minimally invasive group
Respiratory complications30 days postoperativelyAll respiratory complications
Overall complications30 days postoperativelyOverall complications related to the surgical procedure
Post-hepatectomy liver failure30 days postoperativelyOccurrence of post-hepatectomy liver failure (ISGLS definition and classification)
Bile leak30 days postoperativelyOccurrence of bile leak (ISGLS definition and classification)
Ascites30 days postoperativelyOccurrence of ascites
Mortality90 days postoperativelyPostoperative mortality
Red blood cell transfusionDuring the surgical procedureIntraoperative red blood cell transfusion
Wound-related complications30 days postoperativelyAll wound-related complications

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026