Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Sponsor

University of Alexandria (Other)

Overall Status

Recruiting

CT.gov ID

NCT03806439

Collaborator

(none)

100

Enrollment

Location

12.9

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium Radical Cystectomy	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.

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Actual Study Start Date :

Sep 25, 2021

Anticipated Primary Completion Date :

Sep 24, 2022

Anticipated Study Completion Date :

Oct 24, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Delirium [1 year]
Post-surgical delirium in patients undergoing radical cystectomy.

Secondary Outcome Measures

Mortality [1 year]
Mortality in patients undergoing radical cystectomy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:Adult patients undergoing radical cystectomy. -

Exclusion Criteria: Patient refusal.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Medicine	Alexandria		Egypt	21111

Sponsors and Collaborators

University of Alexandria

Investigators

Principal Investigator: Mohammad Hazem I Ahmad Sabry, MB,ChB MD, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Hazem I. Ahmad Sabry, Lecturer of Anesthesia, University of Alexandria

ClinicalTrials.gov Identifier:

NCT03806439

Other Study ID Numbers:

16/71(8/2/2017)

First Posted:

Jan 16, 2019

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Study Results

No Results Posted as of Sep 28, 2021