Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium occurs after major abdominal surgery may reach about 15% of the patients.(1) Aim The aim of this study is to determine the incidence of delirium after radical cystectomy surgery and the associated risk factors in Alexandria University hospital. Patients and Methods After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.
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 Nov 2028
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
January 5, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedStudy Start
First participant enrolled
November 25, 2028
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2029
Study Completion
Last participant's last visit for all outcomes
November 24, 2029
April 3, 2025
March 1, 2025
12 months
January 5, 2019
March 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Delirium
Post-surgical delirium in patients undergoing radical cystectomy.
1 year
Secondary Outcomes (1)
Mortality
1 year
Study Arms (1)
Patients undergoing radical cystectomy.
After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.
Interventions
Adult patients undergoing radical cystectomy.
Eligibility Criteria
Adult patients undergoing radical cystectomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Raats JW, van Eijsden WA, Crolla RM, Steyerberg EW, van der Laan L. Risk Factors and Outcomes for Postoperative Delirium after Major Surgery in Elderly Patients. PLoS One. 2015 Aug 20;10(8):e0136071. doi: 10.1371/journal.pone.0136071. eCollection 2015.
PMID: 26291459RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad Hazem I Ahmad Sabry, MB,ChB MD
Alexandria University
Central Study Contacts
Mohammad Hazem I Sabry
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesia
Study Record Dates
First Submitted
January 5, 2019
First Posted
January 16, 2019
Study Start (Estimated)
November 25, 2028
Primary Completion (Estimated)
November 24, 2029
Study Completion (Estimated)
November 24, 2029
Last Updated
April 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share