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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630978
• Other study ID #: 2018.01
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2019
• Source: San Camillo Hospital, Rome
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Liver Neoplasms
• Postoperative Complications
• Sarcopenia

Intervention

Procedure:
• Liver resection
Major or minor, open or laparoscopic liver resection

Locations

Country	Name	City	State
Italy	San Camillo Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
San Camillo Hospital, Rome

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Harimoto N, Yoshizumi T, Izumi T, Motomura T, Harada N, Itoh S, Ikegami T, Uchiyama H, Soejima Y, Nishie A, Kamishima T, Kusaba R, Shirabe K, Maehara Y. Clinical Outcomes of Living Liver Transplantation According to the Presence of Sarcopenia as Defined b — View Citation

Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.000000 — View Citation

Zhang G, Meng S, Li R, Ye J, Zhao L. Clinical significance of sarcopenia in the treatment of patients with primary hepatic malignancies, a systematic review and meta-analysis. Oncotarget. 2017 Jul 28;8(60):102474-102485. doi: 10.18632/oncotarget.19687. eC — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Patients experiencing medical or surgical complications after surgery	within 90 days after surgery
Secondary	Mortality	Patients dying after surgery	within 90 days after surgery
Secondary	Readmission rate	patients readmitted to hospital after discharge	within 90 days after discharge