- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481994
Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery (Value-Based As)
Study Overview
Status
Conditions
Detailed Description
The study is particularly focused on collecting patients' value-based medical history before and immediately after surgery. Respondents must meet specific inclusion criteria to undergo surgical procedures classified as BUPA D-hemicolectomy, rectal resection, urological surgery (cystectomy or radical nephrectomy), or resection of malignant brain tumors. Patients scheduled for surgical intervention initially underwent an assessment in the anesthesiology clinic, where they were informed about the possibility of participating in the study. Upon signing the informed consent, the collection of their value-based medical history commenced. Following surgery and prior to discharge from the intensive care unit (ICU), a subsequent interview was conducted, during which responses were compared and potential changes in personal attitudes were evaluated [1,2, 3].
The value-based medical history was obtained following a predefined set of questions. The aim of the study is to determine whether collecting value-based medical history reveals patients' level of awareness regarding their illness, their expectations, and any shifts in attitudes after surgery and hospitalization in the ICU at ARIM KNTB Zlín. The findings may indicate further hypotheses related to the collection of value-based medical history.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Zlín, Czechia, 76001
- Tomas Bata regional Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
• Age ≥ 65 years
- Type of procedure: hemicolectomy, rectal amputation, cystectomy, extensive nephrectomy, malignant brain tumor
- ASA classification III
- No sensory impairment (blindness, deafness, deaf-muteness)
- Patients had access to sensory aids (glasses) during assessment
- No legal incapacity
- Consent to participate in the study
- Signed informed consent
- Postoperative hospitalization in the ICU (anticipated during pre-anesthetic examination)
Exclusion Criteria:
• Glasgow Coma Scale ≤ 14
- Somnolence, coma
- Known psychiatric disorder
- Effect of premedication, psychiatric or analgesic-sedative drugs during cognitive function assessment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Understanding of illness
Time Frame: one week before surgery
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one week before surgery
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Identification of a close person
Time Frame: one week before surgery
|
|
one week before surgery
|
|
Patient values and preferences
Time Frame: one week before surgery
|
What is important to you in life?
Besides the surgery, what else do you think about?
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one week before surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ARIM Tomas Bata Hospital Zlin
- Radovan Turek (Other Identifier: ARIM Tomas Bata Hospital Zlin)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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