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Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

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ClinicalTrials.gov Identifier: NCT03806439
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Mohammad Hazem I. Ahmad Sabry, University of Alexandria

Study Description
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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
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.

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
Actual Study Start Date : September 25, 2021
Estimated Primary Completion Date : September 24, 2022
Estimated Study Completion Date : October 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Delirium [ Time Frame: 1 year ]
    Post-surgical delirium in patients undergoing radical cystectomy.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
    Mortality in patients undergoing radical cystectomy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing radical cystectomy.
Criteria

Inclusion Criteria:Adult patients undergoing radical cystectomy. -

Exclusion Criteria: Patient refusal.

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806439


Contacts
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Contact: Mohammad Hazem I Ahmad Sabry, MB,ChB 01062718827 mohammad_hazem@yahoo.com
Contact: Mohammad Hazem I Sabry

Locations
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Egypt
Alexandria Faculty of Medicine Recruiting
Alexandria, Egypt, 21111
Contact: Mohammad Hazem I Ahmad Sabry, MB,ChB MD    +2034842236    mohammad_hazem@yahoo.com   
Sponsors and Collaborators
University of Alexandria
Investigators
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Principal Investigator: Mohammad Hazem I Ahmad Sabry, MB,ChB MD Alexandria University
More Information
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Additional Information:

Publications of Results:

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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: January 16, 2019    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders