Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

Completed

• Conditions: Postoperative Complications; Liver Neoplasms; Sarcopenia
• Interventions: Procedure: Liver resection

• Registration Number: NCT03630978
• Lead Sponsor: San Camillo Hospital, Rome

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Status Verified: 2019-12
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Last Update Submitted: 2019-12-22
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver resection	Liver resection	-

Primary Outcome Measures

Name	Time	Method
Morbidity	within 90 days after surgery	Patients experiencing medical or surgical complications after surgery

Secondary Outcome Measures

Name	Time	Method
Mortality	within 90 days after surgery	Patients dying after surgery
Readmission rate	within 90 days after discharge	patients readmitted to hospital after discharge

Trial Locations

Locations (1)

San Camillo Hospital; 🇮🇹 Rome, Italy