Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06016829
Collaborator
Ankara City Hospital Bilkent (Other)
120
2
31.2
60
1.9

Study Details

Study Description

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 Phase
  • Diagnostic Test: Nutrition Risk Screening 2002 (NRS-2002)
  • Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM)
  • Diagnostic Test: Patient Generated Subjective Global Assessment (PG-SGA)
  • 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, and waist circumference, hip circumference, mid upper arm circumference, and calf circumference will be measured with a non-stretchable tape measure. 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), the Global Leadership Initiative on Malnutrition (GLIM) and the Patient Generated Subjective Global Assessment (PG-SGA). 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

Study Type:
Observational
Anticipated Enrollment :
120 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 :
Jul 25, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Postoperative complications [within 30 days after surgery]

    Complications graded by Clavien-Dindo Complication Classification System

  2. Postoperative quality of life [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey 06100
2 Ankara City Hospital Bilkent Ankara Turkey 06800

Sponsors and Collaborators

  • Hacettepe University
  • Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Tuba N Yildiz Kopuz, Hacettepe University
  • Principal Investigator: Mehmet Fisunoglu, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tuba Nur Yildiz Kopuz, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT06016829
Other Study ID Numbers:
  • GO 21/499
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
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, Principal Investigator, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023