Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Overview

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 Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Delirium
    • Time Frame: 1 year
    • Post-surgical delirium in patients undergoing radical cystectomy.

Secondary Measures

  • Mortality
    • Time Frame: 1 year
    • Mortality in patients undergoing radical cystectomy.

Participating in This Clinical Trial

Inclusion Criteria

Adult patients undergoing radical cystectomy. - Exclusion Criteria:

Patient refusal. -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alexandria
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammad Hazem I. Ahmad Sabry, Lecturer of Anesthesia – University of Alexandria
  • Overall Official(s)
    • Mohammad Hazem I Ahmad Sabry, MB,ChB MD, Principal Investigator, Alexandria University
  • Overall Contact(s)
    • Mohammad Hazem I Ahmad Sabry, MB,ChB, 01062718827, mohammad_hazem@yahoo.com

Citations Reporting on Results

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.

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