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Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

The Impact of Sarcopenia, Body Composition and Other Biometric Parameters on the Postoperative Outcomes of Patients Undergoing Liver Resection for Different Indications

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03630978
Enrollment
251
Registered
2018-08-15
Start date
2018-07-01
Completion date
2019-12-20
Last updated
2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Neoplasms, Postoperative Complications, Sarcopenia

Keywords

hepatocellular carcinoma, colorectal liver metastases, non-colorectal liver metastases, focal nodular hyperplasia, liver hemangioma, liver cysts, surgical morbidity, surgical mortality, sarcopenia

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

Interventions

PROCEDURELiver resection

Major or minor, open or laparoscopic liver resection

Sponsors

San Camillo Hospital, Rome
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Patients undergoing open or laparoscopic liver resection 2. Patients undergoing major or minor liver resection 3. Patients undergoing liver resection for primary or secondary liver malignancies 4. Patients undergoing liver resections for benign diseases (cysts, adenoma, focal nodular hyperplasia, hemangioma) -

Exclusion criteria

1. Patients undergoing extrahepatic resection 2. Patients undergoing cyst fenestration or biopsies without liver resections 3. Patients with extrahepatic metastases 4. Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -

Design outcomes

Primary

MeasureTime frameDescription
Morbiditywithin 90 days after surgeryPatients experiencing medical or surgical complications after surgery

Secondary

MeasureTime frameDescription
Mortalitywithin 90 days after surgeryPatients dying after surgery
Readmission ratewithin 90 days after dischargepatients readmitted to hospital after discharge

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026