Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Radical Cystectomy
• Intervention / Treatment: Other: Radical cystectomy.

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mohammad Hazem I Ahmad Sabry, MB,ChB; Phone Number: 01062718827; Email: mohammad_hazem@yahoo.com
• Study Contact Backup: Name: Mohammad Hazem I Sabry

Study Locations

• Egypt
  • Alexandria, Egypt, 21111
    • Alexandria Faculty of Medicine
    • Contact: Mohammad Hazem I Ahmad Sabry, MB,ChB MD; Phone Number: +2034842236; Email: mohammad_hazem@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing radical cystectomy.

Description

Inclusion Criteria:Adult patients undergoing radical cystectomy. -

Exclusion Criteria: Patient refusal.

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Post-surgical delirium in patients undergoing radical cystectomy.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality in patients undergoing radical cystectomy.	1 year

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Mohammad Hazem I Ahmad Sabry, MB,ChB MD, Alexandria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2024
• Primary Completion (Estimated): November 24, 2025
• Study Completion (Estimated): November 24, 2025

Study Registration Dates

• First Submitted: January 5, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 16/71(8/2/2017)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No