Malnutrition is a Severe Health Issue for Cancer Patients. This Study Examines How Preoperative Nutritional Status Affects Postoperative Delirium in Patients Undergoing Major Abdominal Surgery for Gynecological and Gastrointestinal Tumors.

October 24, 2024 updated by: Ozlem Sen, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Malnutrition is a Severe Health Issue for Cancer Patients. This Study Examines How Preoperative Nutritional Status Affects Postoperative Delirium in Patients Undergoing Major Abdominal Surgery for Gynecological and Gastrointestinal Tumors. the Study Highlights the Critical Role of Preoperative Malnutrition in Delirium and Recommends That All Patients Scheduled for Major Abdominal Surgery Be Evaluated for Nutritional Status At the Outset.

The World Health Organization (WHO) identifies malnutrition as a significant public health threat. It is a common issue among cancer patients due to various factors. Specific nutrient deficiencies can lead to severe cognitive problems. This study aims to evaluate the impact of preoperative nutritional status on the frequency of postoperative delirium. Additionally, we will compare different parameters that can be used to diagnose preoperative malnutrition.

We included a total of 120 patients aged over 18 years, classified as ASA I-IV, who were undergoing major abdominal surgery for gynecological or gastrointestinal tumors and were expected to remain in the postoperative care unit for more than 24 hours. The patients' preoperative scores, albumin levels, prealbumin levels, and other relevant data were recorded. In the first 24 hours post-surgery, delirium was assessed using the Ramsay Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Ozlem Sen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours.

Description

Inclusion Criteria:

  • ASA I-IV
  • Over 18 years of age
  • Undergoing major abdominal surgery for gynecological and GIS tumor
  • Expected to stay in postoperative care unit for more than 24 hours

Exclusion Criteria:

  • Under age 18.
  • Patients scheduled for emergency surgery, pregnancy, who want to withdraw from postoperative work.
  • Patients with dementia, Alzheimer, psychiatric illness, illiterate people.
  • Patients with speech, vision and hearing problems.
  • Patients with a history of alcoholism.
  • Patients who need postoperative mechanical ventilation support (patients who develop heart or respiratory failure due to COPD, heart failure, pulmonary embolism and similar reasons)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAM-ICU
Time Frame: 24 hours
The confusion assessment method for the intensive care unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hazel06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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