NCT06657599

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

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
Last Updated

October 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 27, 2024

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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)

Location

MeSH Terms

Conditions

MalnutritionEmergence DeliriumAbdominal Neoplasms

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasms

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

Locations