NCT06016829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

August 23, 2023

Last Update Submit

February 26, 2024

Conditions

Colorectal Cancer

Keywords

colorectal cancernutritional statusbody compositionquality of lifepostoperative complication

Outcome Measures

Primary Outcomes (3)

  • Postoperative complications

    Complications graded by Clavien-Dindo Complication Classification System

    within 30 days after surgery

  • Postoperative quality of life

    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.

    within 45 days after surgery

  • EORTC-QLQ-CR29

    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.

    within 45 days after surgery

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 years and older who have undergone surgical treatment for a diagnosis of colorectal cancer

You may qualify if:

  • Having been diagnosed with colorectal cancer and having surgical treatment planned
  • Being 18 years of age or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Ankara City Hospital Bilkent

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tuba N Yildiz Kopuz

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Mehmet Fisunoglu

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 30, 2023

Study Start

July 25, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

TU(2)