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.
1 other identifier
observational
120
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedOctober 26, 2024
August 1, 2024
1.2 years
August 27, 2024
October 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
CAM-ICU
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
Interventions
Patients with ASA I-IV, over 18 years of age, undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours.
Eligibility Criteria
Patients undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ozlem Sen
Ankara, 06000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology and Reanimation Specialist MD.
Study Record Dates
First Submitted
August 27, 2024
First Posted
October 24, 2024
Study Start
June 1, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
October 26, 2024
Record last verified: 2024-08