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Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06016829
Recruitment Status : Completed
First Posted : August 30, 2023
Last Update Posted : February 28, 2024
Sponsor:
Collaborator:
Ankara City Hospital Bilkent
Information provided by (Responsible Party):
Tuba Nur Yildiz Kopuz, Hacettepe University

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: Nutrition Risk Screening 2002 (NRS-2002) Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM) Other: Measurement of body composition with computed tomography (CT) Diagnostic Test: Dietary inflammatory index (DII) Diagnostic Test: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Diagnostic Test: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) Diagnostic Test: Prognostic Nutritional Index (PNI) Diagnostic Test: Neutrophil-Lymphocyte Ratio (NLR)

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.

Study Design
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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.
Actual Study Start Date : July 25, 2021
Actual Primary Completion Date : December 1, 2022
Actual Study Completion Date : December 1, 2022
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Nutrition Risk Screening 2002 (NRS-2002)
    Nutritional status assessment tool
  • Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM)
    Nutritional status assessment tool
  • 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), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)
  • Diagnostic Test: Dietary inflammatory index (DII)
    The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet.
  • Diagnostic Test: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
    Quality of life assessment tool
  • Diagnostic Test: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)
    Quality of life assessment tool
  • Diagnostic Test: Prognostic Nutritional Index (PNI)
    Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count
  • Diagnostic Test: Neutrophil-Lymphocyte Ratio (NLR)
    The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.

Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 years and older who have undergone surgical treatment for a diagnosis of colorectal cancer
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016829


Locations
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Turkey
Hacettepe University
Ankara, Turkey, 06100
Ankara City Hospital Bilkent
Ankara, Turkey, 06800
Sponsors and Collaborators
Hacettepe University
Ankara City Hospital Bilkent
Investigators
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Principal Investigator: Tuba N Yildiz Kopuz Hacettepe University
Principal Investigator: Mehmet Fisunoglu Hacettepe University
More Information
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Responsible Party: Tuba Nur Yildiz Kopuz, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT06016829    
Other Study ID Numbers: GO 21/499
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuba Nur Yildiz Kopuz, Hacettepe University:
colorectal cancer
nutritional status
body composition
quality of life
postoperative complication
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases