Nutritional Risk Factors and Colorectal Surgery

Sponsor
University Clinic Dr Dragisa Misovic-Dedinje (Other)
Overall Status
Recruiting
CT.gov ID
NCT05957744
Collaborator
(none)
120
1
15
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
  • 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 BoboŇ°, 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:

Study Results

No Results Posted as of Jul 24, 2023