Colorectal CancerNCT05957744
Nutritional Risk Factors and Colorectal Surgery
An observational study of Colorectal Cancer and Nutrition Related Cancer, run by University Clinic Dr Dragisa Misovic-Dedinje at 1 site in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer, Nutrition Related Cancer
- What is being tested?
- Colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jun 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with operable carcinoma of the colon or rectum
Who may be able to join
- Colorectal cancer
- First operation of this type
Who cannot join
- Urgent surgery
- Peritoneal carcinomatosis
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"
Belgrade, 11000
Marina Boboš, +381641391525, marinamorisan@gmail.com
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Nutrition Related Cancer
- Being tested
- Colorectal surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal surgeryProcedure or surgery
Right hemicolectomy, left colectomy, total colectomy, anterior resection
| Study group | Role | What they receive |
|---|---|---|
| Group with colorectal cancer and malnutrition | Not described Receives: Procedure: Colorectal surgery | |
| Group with colorectal cancer without malnutrition | Not described Receives: Procedure: Colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jun 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinic Dr Dragisa Misovic-Dedinje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Boboš, University Clinic Dr Dragisa Misovic-Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957744
- Sponsor's protocol ID
- /2-2023
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Risk Factors in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05957744
- Acronym / sponsor ID
- /2-2023
- Conditions
- Colorectal Cancer, Nutrition Related Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Clinic Dr Dragisa Misovic-DedinjeUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with colorectal cancer and malnutrition | – | Procedure: Colorectal surgery |
| Group with colorectal cancer without malnutrition | – | Procedure: Colorectal surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable carcinoma of the colon or rectum
Key inclusion criteria (2 listed)
- Colorectal cancer
- First operation of this type
Key exclusion criteria (2 listed)
- Urgent surgery
- Peritoneal carcinomatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal surgeryRight hemicolectomy, left colectomy, total colectomy, anterior resection | Procedure or surgery | Group with colorectal cancer and malnutrition, Group with colorectal cancer without malnutrition |
Primary outcome
Length of stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"
Belgrade, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Nutrition Related Cancer, run by University Clinic Dr Dragisa Misovic-Dedinje at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.