Clinical trial NCT05475054: Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Liver Metastases
Obesity
Keywords: overweight
fatty liver
open liver resection
laparoscopic liver resection
minimally invasive liver resection
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands
name: The Queen Elizabeth Hospital
name: Umberto I Mauriziano Hospital, Turin, Italy
name: Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway
name: Padua University Hospital, Padua, Italy
name: IRCCS San Raffaele
name: Hospital Doctor Josep Trueta de Girona, Girona, Catalonia, Spain
name: Clinica Universidad de Navarra, Pamplona, Spain
name: Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France
name: Groeninge Hospital, Kortrijk, Belgium
name: University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
name: Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy
name: University of Verona, Verona, Italy
name: Virginia Mason Medical Center, Seattle, USA
name: University of California San Francisco, California, USA
name: Moscow Clinical Research Centre, Moscow, Russia
name: Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy
name: Antoine Béclère Hospital, Paris, France
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: University of Modena and Reggio Emilia, Modena, Italy
First posted: 2022-07-26
Enrollment: 9963
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major complications
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Overall complications
timeFrame: 30 days postoperatively
measure: Length of hospital stay
timeFrame: 30 days postoperatively
measure: R0 resection margin
timeFrame: 30 days postoperatively
measure: Intraoperative blood loss
timeFrame: During the surgical procedure
measure: Operative time
timeFrame: During the surgical procedure
measure: Conversion to open surgery
timeFrame: During the surgical procedure
measure: Respiratory complications
timeFrame: 30 days postoperatively
measure: Wound-related complications
timeFrame: 30 days postoperatively
measure: Post-hepatectomy liver failure
timeFrame: 30 days postoperatively
measure: Bile leak
timeFrame: 30 days postoperatively
measure: Ascites
timeFrame: 30 days postoperatively
measure: Mortality
timeFrame: 90 days postoperatively
measure: Red blood cell transfusion
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
Study officials:
References: