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

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.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Liver Metastases; Liver Cancer
• Intervention / Treatment: Procedure: Minimally invasive liver resection

• Study Type: Observational
• Enrollment (Actual): 9963

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza Istituto Ospedaliero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; A liver resection performed by minimally invasive (keyhole) surgery; Other Names: Laparoscopic liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complications	Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure	30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss in milliliters	During the surgical procedure
Overall complications	Overall complications related to the surgical procedure	30 days postoperatively
Length of hospital stay	The length of hospital stay for the surgical procedure	30 days postoperatively
Operative time	Operative time in minutes	During the surgical procedure
Conversion to open surgery	Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group	During the surgical procedure
Mortality	Postoperative mortality	90 days postoperatively
Red blood cell transfusion	Intraoperative red blood cell transfusion	During the surgical procedure
R0 resection margin	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	30 days postoperatively
Respiratory complications	All respiratory complications	30 days postoperatively
Wound-related complications	All wound-related complications	30 days postoperatively
Post-hepatectomy liver failure	Occurrence of post-hepatectomy liver failure (ISGLS definition and classification)	30 days postoperatively
Bile leak	Occurrence of bile leak (ISGLS definition and classification)	30 days postoperatively
Ascites	Occurrence of ascites	30 days postoperatively

Collaborators and Investigators

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero
• Collaborators: The Queen Elizabeth Hospital; Clinica Universidad de Navarra, Pamplona, Spain; Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands; Umberto I Mauriziano Hospital, Turin, Italy; Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway; Padua University Hospital, Padua, Italy; IRCCS San Raffaele Hospital, Milan, Italy; Hospital Doctor Josep Trueta de Girona, Girona, Catalonia, Spain; Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France; Groeninge Hospital, Kortrijk, Belgium; University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy; University of Verona, Verona, Italy; Virginia Mason Medical Center, Seattle, USA; University of California San Francisco, California, USA; Moscow Clinical Research Centre, Moscow, Russia; Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy; Antoine Béclère Hospital, Paris, France; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; University of Modena and Reggio Emilia, Modena, Italy

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: overweight; fatty liver; laparoscopic liver resection; open liver resection; minimally invasive liver resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Hematinics; Liver Extracts
• Other Study ID Numbers: NP5469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data of this study will be available from the corresponding author, Professor Mohammed Abu Hilal, upon reasonable request. The data are not publicly available since this could compromise the privacy of research participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No