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

NCT ID: NCT05475054

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9963 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-07-22

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer Liver Metastases Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Open liver resection

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

No interventions assigned to this group

Minimally invasive liver resection

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

Minimally invasive liver resection

Intervention Type PROCEDURE

A liver resection performed by minimally invasive (keyhole) surgery

Interventions

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Minimally invasive liver resection

A liver resection performed by minimally invasive (keyhole) surgery

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic liver resection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

The Queen Elizabeth Hospital

OTHER

Sponsor Role collaborator

Umberto I Mauriziano Hospital, Turin, Italy

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway

UNKNOWN

Sponsor Role collaborator

Padua University Hospital, Padua, Italy

UNKNOWN

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role collaborator

University Hospital of Girona Dr. Josep Trueta

NETWORK

Sponsor Role collaborator

Clinica Universidad de Navarra, Pamplona, Spain

UNKNOWN

Sponsor Role collaborator

Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France

UNKNOWN

Sponsor Role collaborator

Groeninge Hospital, Kortrijk, Belgium

UNKNOWN

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom

UNKNOWN

Sponsor Role collaborator

Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy

UNKNOWN

Sponsor Role collaborator

University of Verona, Verona, Italy

UNKNOWN

Sponsor Role collaborator

Virginia Mason Medical Center, Seattle, USA

UNKNOWN

Sponsor Role collaborator

University of California San Francisco, California, USA

UNKNOWN

Sponsor Role collaborator

Moscow Clinical Research Centre, Moscow, Russia

UNKNOWN

Sponsor Role collaborator

Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy

UNKNOWN

Sponsor Role collaborator

Antoine Béclère Hospital, Paris, France

UNKNOWN

Sponsor Role collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role collaborator

University of Modena and Reggio Emilia, Modena, Italy

UNKNOWN

Sponsor Role collaborator

Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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NP5469

Identifier Type: -

Identifier Source: org_study_id

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