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

Completed

• Conditions: Obesity; Liver Cancer; Liver Metastases
• Interventions: Procedure: Minimally invasive liver resection

• Registration Number: NCT05475054
• Lead Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-22
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9963

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally invasive liver resection	Minimally invasive liver resection	Non-obese or obese patients that underwent a minimally invasive liver resection for all indications

Primary Outcome Measures

Name	Time	Method
Major complications	30 days postoperatively	Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Poliambulanza Istituto Ospedaliero; 🇮🇹 Brescia, Italy