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Completed

NCT Number: NCT05475054

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

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.

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Key information

Conditions

Liver Cancer Body Weight Digestive System Diseases Digestive System Neoplasms Fatty Liver Liver Diseases Liver Metastases Liver Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive liver resection

Procedure

A liver resection performed by minimally invasive (keyhole) surgery

Other names: Laparoscopic liver resection

Primary outcomes

  1. Major complications

    Time frame: 30 days postoperatively

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

Secondary outcomes

  1. Overall complications

    Time frame: 30 days postoperatively

    Overall complications related to the surgical procedure

  2. Length of hospital stay

    Time frame: 30 days postoperatively

    The length of hospital stay for the surgical procedure

  3. R0 resection margin

    Time frame: 30 days postoperatively

    Proportion 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

  4. Intraoperative blood loss

    Time frame: During the surgical procedure

    Intraoperative blood loss in milliliters

  5. Operative time

    Time frame: During the surgical procedure

    Operative time in minutes

  6. Conversion to open surgery

    Time frame: During the surgical procedure

    Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group

  7. Respiratory complications

    Time frame: 30 days postoperatively

    All respiratory complications

  8. Wound-related complications

    Time frame: 30 days postoperatively

    All wound-related complications

  9. Post-hepatectomy liver failure

    Time frame: 30 days postoperatively

    Occurrence of post-hepatectomy liver failure (ISGLS definition and classification)

  10. Bile leak

    Time frame: 30 days postoperatively

    Occurrence of bile leak (ISGLS definition and classification)

  11. Ascites

    Time frame: 30 days postoperatively

    Occurrence of ascites

  12. Mortality

    Time frame: 90 days postoperatively

    Postoperative mortality

  13. Red blood cell transfusion

    Time frame: During the surgical procedure

    Intraoperative red blood cell transfusion

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Antoine Béclère Hospital, Paris, France
  • Catholic University of the Sacred Heart
  • Clinica Universidad de Navarra, Universidad de Navarra
  • Groeninge Hospital, Kortrijk, Belgium
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS San Raffaele
  • Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France
  • Moscow Clinical Research Centre, Moscow, Russia
  • Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway
  • Padua University Hospital, Padua, Italy
  • Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy
  • The Queen Elizabeth Hospital
  • Umberto I Mauriziano Hospital, Turin, Italy
  • Universita di Verona
  • University Hospital Southampton NHS Foundation Trust
  • University Hospital of Girona Dr. Josep Trueta
  • University of California, San Francisco
  • University of Modena and Reggio Emilia
  • Virginia Mason Medical Center, Seattle, USA

Registry information

Official study title

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.

Acronym: MILSOBES

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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