Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

San Camillo Hospital, Rome

Status: Completed

Conditions: Postoperative Complications; Liver Neoplasms; Sarcopenia

Treatments: Procedure: Liver resection

Study type: Observational

Funder types: Other

Identifiers

NCT03630978

2018.01

Details and patient eligibility

About

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.

Full 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

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

251 participants in 1 patient group

Liver resection

Treatment:

Procedure: Liver resection