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NCT Number: NCT06016829

Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital Bilkent, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Nutrition Risk Screening 2002 (NRS-2002)

Diagnostic Test

Nutritional status assessment tool

Global Leadership Initiative on Malnutrition (GLIM)

Diagnostic Test

Nutritional status assessment tool

Measurement of body composition with computed tomography (CT)

Other

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), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)

Dietary inflammatory index (DII)

Diagnostic Test

The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet.

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

Diagnostic Test

Quality of life assessment tool

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)

Diagnostic Test

Quality of life assessment tool

Prognostic Nutritional Index (PNI)

Diagnostic Test

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

Neutrophil-Lymphocyte Ratio (NLR)

Diagnostic Test

The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.

Primary outcomes

  1. Postoperative complications

    Time frame: within 30 days after surgery

    Complications graded by Clavien-Dindo Complication Classification System

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Ankara City Hospital Bilkent

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2023
Registry last updated
Feb 28, 2024

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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