Clinical trial NCT06016829: Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer
Official title: The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
nutritional status
body composition
quality of life
postoperative complication
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2023-08-30
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years and older who have undergone surgical treatment for a diagnosis of colorectal cancer

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.

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.

Primary outcomes:
measure: Postoperative complications
timeFrame: within 30 days after surgery
measure: Postoperative quality of life
timeFrame: within 45 days after surgery
measure: EORTC-QLQ-CR29
timeFrame: within 45 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
affiliation: Hacettepe University
name: Tuba N Yildiz Kopuz
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Mehmet Fisunoglu
role: PRINCIPAL_INVESTIGATOR
References: