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

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05475054
• Collaborator: Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (Other), The Queen Elizabeth Hospital (Other), Umberto I Mauriziano Hospital, Turin, Italy (Other), Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway (Other), Padua University Hospital, Padua, Italy (Other), IRCCS San Raffaele Hospital, Milan, Italy (Other), Hospital Doctor Josep Trueta de Girona, Girona, Catalonia, Spain (Other), Clinica Universidad de Navarra, Pamplona, Spain (Other), Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France (Other), Groeninge Hospital, Kortrijk, Belgium (Other), University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom (Other), Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy (Other), University of Verona, Verona, Italy (Other), Virginia Mason Medical Center, Seattle, USA (Other), University of California San Francisco, California, USA (Other), Moscow Clinical Research Centre, Moscow, Russia (Other), Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy (Other), Antoine Béclère Hospital, Paris, France (Other), IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (Other), University of Modena and Reggio Emilia, Modena, Italy (Other)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 509

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer; Liver Metastases; Obesity	Procedure: Minimally invasive liver resection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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.
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: Jul 18, 2022
• Anticipated Study Completion Date: Jul 22, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Major complications [30 days postoperatively]

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

Secondary Outcome Measures

1. Overall complications [30 days postoperatively]

   Overall complications related to the surgical procedure

2. Length of hospital stay [30 days postoperatively]

   The length of hospital stay for the surgical procedure

3. R0 resection margin [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 [During the surgical procedure]

   Intraoperative blood loss in milliliters

5. Operative time [During the surgical procedure]

   Operative time in minutes

6. Conversion to open surgery [During the surgical procedure]

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

7. Respiratory complications [30 days postoperatively]

   All respiratory complications

8. Wound-related complications [30 days postoperatively]

   All wound-related complications

9. Post-hepatectomy liver failure [30 days postoperatively]

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

10. Bile leak [30 days postoperatively]

    Occurrence of bile leak (ISGLS definition and classification)

11. Ascites [30 days postoperatively]

    Occurrence of ascites

12. Mortality [90 days postoperatively]

    Postoperative mortality

13. Red blood cell transfusion [During the surgical procedure]

    Intraoperative red blood cell transfusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Poliambulanza Istituto Ospedaliero	Brescia		Italy	25124

Sponsors and Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero
• Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands
• The Queen Elizabeth Hospital
• 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
• Clinica Universidad de Navarra, Pamplona, 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Poliambulanza Istituto Ospedaliero
• ClinicalTrials.gov Identifier: NCT05475054
• Other Study ID Numbers: NP5469
• First Posted: Jul 26, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero: overweight; fatty liver; open liver resection; laparoscopic liver resection; minimally invasive liver resection
• Additional relevant MeSH terms: Liver Neoplasms; Liver Extracts

Study Results

No Results Posted as of Jul 26, 2022