Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma

NCT05631379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-10-17

No results posted yet for this study

Summary

This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.

Conditions

  • Retroperitoneal Sarcoma
  • Body Composition
  • Malnutrition
  • Sarcopenia
  • Sarcopenic Obesity
  • Myosteatosis

Interventions

OTHER

Measurement of body composition with computed tomography (CT)

The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), muscle radiation attenuation (MRA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)

DIAGNOSTIC_TEST

GLIM malnutrition criteria

GLIM criteria (Global Leadership Initiative on Malnutrition) will be applied to assess malnutrition

DIAGNOSTIC_TEST

EWGSOP2 sarcopenia criteria

EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia

DIAGNOSTIC_TEST

ESPEN-EASO criteria for sarcopenic obesity

The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) consensus criteria from 2018 will be applied to assess sarcopenic obesity

DIAGNOSTIC_TEST

Prognostic Nutritional Index (PNI)

Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count

DIAGNOSTIC_TEST

The high-sensitivity modified Glasgow prognostic score

The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) is an inflammation-based score consisted of C-reactive protein level and serum albumin

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Manuel Ramanović, M.D. · Institute of Oncology Ljubljana, Ljubljana

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-02
Primary Completion
2024-04-04
Completion
2024-04-04

Countries

  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631379 on ClinicalTrials.gov