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

Obesity Clinical Trial

— MILSOBES  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475054
• Other study ID #: NP5469
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: July 22, 2022

Study information

• Verified date: February 2023
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9963
• Est. completion date: July 22, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Metastases
• Liver Neoplasms
• Obesity

Intervention

Procedure:
• Minimally invasive liver resection
A liver resection performed by minimally invasive (keyhole) surgery

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia

Sponsors (21)

Lead Sponsor

Collaborator

Fondazione Poliambulanza Istituto Ospedaliero

Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands, Antoine Béclère Hospital, Paris, France, Clinica Universidad de Navarra, Pamplona, Spain, Groeninge Hospital, Kortrijk, Belgium, Hospital Doctor Josep Trueta de Girona, Girona, Catalonia, Spain, Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy, IRCCS San Raffaele Hospital, Milan, Italy, 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, Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, University of California San Francisco, California, USA, University of Modena and Reggio Emilia, Modena, Italy, University of Verona, Verona, Italy, Virginia Mason Medical Center, Seattle, USA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complications	Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure	30 days postoperatively
Secondary	Overall complications	Overall complications related to the surgical procedure	30 days postoperatively
Secondary	Length of hospital stay	The length of hospital stay for the surgical procedure	30 days postoperatively
Secondary	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
Secondary	Intraoperative blood loss	Intraoperative blood loss in milliliters	During the surgical procedure
Secondary	Operative time	Operative time in minutes	During the surgical procedure
Secondary	Conversion to open surgery	Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group	During the surgical procedure
Secondary	Respiratory complications	All respiratory complications	30 days postoperatively
Secondary	Wound-related complications	All wound-related complications	30 days postoperatively
Secondary	Post-hepatectomy liver failure	Occurrence of post-hepatectomy liver failure (ISGLS definition and classification)	30 days postoperatively
Secondary	Bile leak	Occurrence of bile leak (ISGLS definition and classification)	30 days postoperatively
Secondary	Ascites	Occurrence of ascites	30 days postoperatively
Secondary	Mortality	Postoperative mortality	90 days postoperatively
Secondary	Red blood cell transfusion	Intraoperative red blood cell transfusion	During the surgical procedure