Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

Sarcopenia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Liver Neoplasms
• Postoperative Complications
• Sarcopenia

• NCT number: NCT03630978
• Study type: Observational
• Source: San Camillo Hospital, Rome
• Status: Completed
• Start date: July 1, 2018
• Completion date: December 20, 2019