Nutritional Risk Factors and Colorectal Surgery

Nutritional Risk Factors in Patients With Colorectal Cancer

This observational study aims to learn about the relationship between the nutritional status of patients with colorectal cancer and clinical outcome after colorectal surgery.

The main question[s] it aims to answer are:

• which anthropometric, laboratory and specific parameters best define that patient is at nutritional risk
• will patients that are at nutritional risk stay longer in the hospital after surgery than those who are not at nutritional risk Patients will be preoperatively examined anthropometrically, radiologically and laboratoryally. Postoperatively, the course of their treatment will be monitored, as well as the monitoring of postoperative complications. A group of patients with and without malnutrition will be compared.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Nutrition Related Cancer
• Intervention / Treatment: Procedure: Colorectal surgery

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"
    • Contact: Marina Boboš; Phone Number: +381641391525; Email: marinamorisan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with operable carcinoma of the colon or rectum

Description

Inclusion Criteria:

• Colorectal cancer
• First operation of this type

Exclusion Criteria:

• Urgent surgery
• Peritoneal carcinomatosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group with colorectal cancer and malnutrition	Procedure: Colorectal surgery; Right hemicolectomy, left colectomy, total colectomy, anterior resection
Group with colorectal cancer without malnutrition	Procedure: Colorectal surgery; Right hemicolectomy, left colectomy, total colectomy, anterior resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of stay	30 days

Collaborators and Investigators

• Sponsor: University Clinic Dr Dragisa Misovic-Dedinje

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 15, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: /2-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No