Nutritional Risk Factors and Colorectal Surgery

• Sponsor: University Clinic Dr Dragisa Misovic-Dedinje (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05957744
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Nutrition Related Cancer	Procedure: Colorectal surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Nutritional Risk Factors in Patients With Colorectal Cancer
• Actual Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Aug 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Length of stay [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Colorectal cancer

• First operation of this type

Exclusion Criteria:

• Urgent surgery

• Peritoneal carcinomatosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"	Belgrade		Serbia	11000

Sponsors and Collaborators

• University Clinic Dr Dragisa Misovic-Dedinje

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marina Boboš, Assistant Professor Dr., University Clinic Dr Dragisa Misovic-Dedinje
• ClinicalTrials.gov Identifier: NCT05957744
• Other Study ID Numbers: /2-2023
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Jul 24, 2023