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

NCT05475054 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9963

Last updated 2023-02-15

No results posted yet for this study

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

PROCEDURE

Minimally invasive liver resection

A liver resection performed by minimally invasive (keyhole) surgery

Sponsors & Collaborators

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

    collaborator OTHER
  • The Queen Elizabeth Hospital

    collaborator OTHER
  • Umberto I Mauriziano Hospital, Turin, Italy

    collaborator UNKNOWN
  • Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway

    collaborator UNKNOWN
  • Padua University Hospital, Padua, Italy

    collaborator UNKNOWN
  • IRCCS San Raffaele

    collaborator OTHER
  • University Hospital of Girona Dr. Josep Trueta

    collaborator NETWORK
  • Clinica Universidad de Navarra, Pamplona, Spain

    collaborator UNKNOWN
  • Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France

    collaborator UNKNOWN
  • Groeninge Hospital, Kortrijk, Belgium

    collaborator UNKNOWN
  • University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom

    collaborator UNKNOWN
  • Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy

    collaborator UNKNOWN
  • University of Verona, Verona, Italy

    collaborator UNKNOWN
  • Virginia Mason Medical Center, Seattle, USA

    collaborator UNKNOWN
  • University of California San Francisco, California, USA

    collaborator UNKNOWN
  • Moscow Clinical Research Centre, Moscow, Russia

    collaborator UNKNOWN
  • Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy

    collaborator UNKNOWN
  • Antoine Béclère Hospital, Paris, France

    collaborator UNKNOWN
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER
  • University of Modena and Reggio Emilia, Modena, Italy

    collaborator UNKNOWN
  • Fondazione Poliambulanza Istituto Ospedaliero

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-07-18
Completion
2022-07-22

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05475054 on ClinicalTrials.gov