Nutritional Risk Factors and Colorectal Surgery | NCT05957744

Studies
Nutritional Risk Factors and Colorectal Surgery

NCT05957744

Sponsor

University Clinic Dr Dragisa Misovic-Dedinje

Status

Unknown status

Last Update Posted

Jul 24, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Nutrition Related Cancer

Interventions

Colorectal surgery

Countries

Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

May 31, 2024Estimated

Completion Date

Aug 31, 2024Estimated

First Submitted Date

Jul 15, 2023

First Submission Date that Met QC Criteria

Jul 15, 2023

First Posted Date

Jul 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2023

Last Update Posted Date

Jul 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marina Boboš, Assistant Professor Dr., University Clinic Dr Dragisa Misovic-DedinjePrincipal Investigator

Lead Sponsor

University Clinic Dr Dragisa Misovic-DedinjeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group with colorectal cancer and malnutrition			Procedure: Colorectal surgery
Group with colorectal cancer without malnutrition			Procedure: Colorectal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colorectal surgery	Procedure	Right hemicolectomy, left colectomy, total colectomy, anterior resection	Group with colorectal cancer and malnutrition Group with colorectal cancer without malnutrition

Measure	Description	Time Frame
Length of stay		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorectal cancer
First operation of this type

Exclusion Criteria:

Urgent surgery
Peritoneal carcinomatosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with operable carcinoma of the colon or rectum

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"	Recruiting	Belgrade		11000	Serbia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided