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OpenTrials
Completed

NCT Number: NCT03630978

Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

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.

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Key information

Conditions

Liver Neoplasms Adenocarcinoma Atrophy Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Focal Nodular Hyperplasia Liver Diseases Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Camillo Hospital

Rome, 00100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients undergoing extrahepatic resection
  • Patients undergoing cyst fenestration or biopsies without liver resections
  • Patients with extrahepatic metastases
  • Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -

Treatment and study plan

liver resection

Procedure

Major or minor, open or laparoscopic liver resection

Primary outcomes

  1. Morbidity

    Time frame: within 90 days after surgery

    Patients experiencing medical or surgical complications after surgery

Secondary outcomes

  1. Mortality

    Time frame: within 90 days after surgery

    Patients dying after surgery

  2. Readmission rate

    Time frame: within 90 days after discharge

    patients readmitted to hospital after discharge

Sponsors and collaborators

Lead sponsor

San Camillo Hospital, Rome

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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