The Impact of Sarcopenia, Body Composition and Other Biometric Parameters on the Postoperative Outcomes of Patients Undergoing Liver Resection for Different Indications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Morbidity
Study Overview
Brief Summary
The investigators will investigate the impact of different biometric parameters (Body mass index, sarcopenia, lean muscle mass, hand-grip strength, gait speed, fat composition) on the postoperative outcomes of patients undergoing liver resections.
Major and minor liver resections will be considered as well as open and minimally invasive techniques.
Benign and malignant indications will be included. Patients characteristics and perioperative variables will be considered for analysis.
Short-term outcomes will be evaluated focusing on 90-days morbidity and mortality and readmission rate.
Detailed Description
According to the null hypothesis, no difference in postoperative morbidity between the two groups would be expected. To calculate sample size, a 42% morbidity rate would be expected in sarcopenic patients while a 22% rate would be expected in the non-sarcopenic group. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 224 subjects. Considering a 10% drop-out rate of patients undergoing explorative laparoscopy or laparotomy without parenchymal resection a total of 249 patients will be required for completion of the study
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients undergoing open or laparoscopic liver resection
- •Patients undergoing major or minor liver resection
- •Patients undergoing liver resection for primary or secondary liver malignancies
- •Patients undergoing liver resections for benign diseases (cysts, adenoma, focal nodular hyperplasia, hemangioma) -
Exclusion Criteria
- •Patients undergoing extrahepatic resection
- •Patients undergoing cyst fenestration or biopsies without liver resections
- •Patients with extrahepatic metastases
- •Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -
Outcomes
Primary Outcomes
Morbidity
Time Frame: within 90 days after surgery
Patients experiencing medical or surgical complications after surgery
Secondary Outcomes
- Mortality(within 90 days after surgery)
- Readmission rate(within 90 days after discharge)
Investigators
Giammauro Berardi
Resident in Surgery, Principal Investigator
San Camillo Hospital, Rome