Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer

NCT ID: NCT06016829

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-25

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Nutrition Risk Screening 2002 (NRS-2002)

Nutritional status assessment tool

Intervention Type DIAGNOSTIC_TEST

Global Leadership Initiative on Malnutrition (GLIM)

Nutritional status assessment tool

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type OTHER

Dietary inflammatory index (DII)

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

Intervention Type DIAGNOSTIC_TEST

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

Quality of life assessment tool

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Prognostic Nutritional Index (PNI)

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

Intervention Type DIAGNOSTIC_TEST

Neutrophil-Lymphocyte Ratio (NLR)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Tuba Nur Yildiz Kopuz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuba N Yildiz Kopuz

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Mehmet Fisunoglu

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Ankara City Hospital Bilkent

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 21/499

Identifier Type: -

Identifier Source: org_study_id

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