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Clinical Trials/NCT06016829
NCT06016829
Completed
Not Applicable

The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.

Hacettepe University2 sites in 1 country121 target enrollmentJuly 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Hacettepe University
Enrollment
121
Locations
2
Primary Endpoint
Postoperative quality of life
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study was to evaluate the effect of preoperative nutritional status, dietary inflammatory index, and systemic inflammatory response on postoperative outcomes. The study will include 120 colorectal cancer patients who are scheduled for surgical treatment.

Detailed Description

A questionnaire form containing general information, dietary habits, and food consumption records will be applied by the researcher in the preoperative period to the patients who volunteered to participate in the study. Body composition will be taken by bioelectrical impedance analysis method. Hand grip strength will be taken with a digital hand dynamometer. The nutritional status of patients will be assessed using the criteria of the Nutritional Risk Screening 2002 (NRS-2002) and the Global Leadership Initiative on Malnutrition (GLIM). For body composition analysis, computed tomography images, known as the gold standard, will be used in cancer patients. Computed tomography images of the patients will be obtained from hospital records at L3 lumbar vertebra level. The software program ImageJ developed by the US National Institute of Health will be used to calculate the visceral fat area (cm2), subcutaneous fat area (cm2), and skeletal muscle area (cm2) from the recorded images. Preoperative biochemical parameters will be obtained from hospital records. The systemic inflammatory response will be determined by the Prognostic Nutritional Index, Neutrophil Lymphocyte Ratio, and Delta Neutrophil Index. The inflammatory load of the diet will be calculated using the Dietary Inflammatory Index. The quality of life of patients will be assessed using cancer-specific scales developed by the European Organisation for Research and Treatment of Cancer (EORTC) during the preoperative and postoperative periods. These scales are EORTC-QLQ-C30 for general quality of life and EORTC-QLQ-CR29 for colorectal cancer-specific quality of life.

Registry
clinicaltrials.gov
Start Date
July 25, 2021
End Date
December 1, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tuba Nur Yildiz Kopuz

Principal Investigator

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Having been diagnosed with colorectal cancer and having surgical treatment planned
  • Being 18 years of age or older

Exclusion Criteria

  • Having received chemotherapy or radiotherapy
  • Currently undergoing corticosteroid or hormone treatment.
  • Presence of distant metastases.
  • Presence of any malignancy other than colorectal cancer.
  • Presence of autoimmune disease.
  • Presence of ongoing infectious disease.

Outcomes

Primary Outcomes

Postoperative quality of life

Time Frame: within 45 days after surgery

Quality of life will be evaluated by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

EORTC-QLQ-CR29

Time Frame: within 45 days after surgery

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) is a supplementary questionnaire module to be employed in conjunction with the Quality of Life Questionnaire Core 30 (QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problem.

Postoperative complications

Time Frame: within 30 days after surgery

Complications graded by Clavien-Dindo Complication Classification System

Study Sites (2)

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