NCT05957744

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 15, 2023

Last Update Submit

July 15, 2023

Conditions

Colorectal CancerNutrition Related Cancer

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    30 days

Study Arms (2)

Group with colorectal cancer and malnutrition

Procedure: Colorectal surgery

Group with colorectal cancer without malnutrition

Procedure: Colorectal surgery

Interventions

Colorectal surgeryPROCEDURE

Right hemicolectomy, left colectomy, total colectomy, anterior resection

Group with colorectal cancer and malnutritionGroup with colorectal cancer without malnutrition

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with operable carcinoma of the colon or rectum

You may qualify if:

  • Colorectal cancer
  • First operation of this type

You may not qualify if:

  • Urgent surgery
  • Peritoneal carcinomatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"

Belgrade, 11000, Serbia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 24, 2023

Study Start

June 1, 2023

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)