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NCT03806439 Clinical Trial

Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Delirium Clinical Trial

Official title:
Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03806439
Other study ID # 16/71(8/2/2017)
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 25, 2024
Est. completion date November 24, 2025

Study information
Verified date December 2023
Source University of Alexandria
Contact Mohammad Hazem I Ahmad Sabry, MB,ChB
Phone 01062718827
Email mohammad_hazem@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

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. Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done. Discussion Results of the study will be discussed compared to other studies.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date November 24, 2025
Est. primary completion date November 24, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:Adult patients undergoing radical cystectomy. - Exclusion Criteria: Patient refusal. -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Radical cystectomy.
Adult patients undergoing radical cystectomy.

Locations
Country Name City State
Egypt Alexandria Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Delirium Post-surgical delirium in patients undergoing radical cystectomy. 1 year
Secondary Mortality Mortality in patients undergoing radical cystectomy. 1 year
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