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NCT Number: NCT03806439

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Radical Cystectomy Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients undergoing radical cystectomy. -

Exclusion criteria

Patient refusal.

-

Treatment and study plan

Radical cystectomy.

Other

Adult patients undergoing radical cystectomy.

Primary outcomes

  1. Delirium

    Time frame: 1 year

    Post-surgical delirium in patients undergoing radical cystectomy.

Secondary outcomes

  1. Mortality

    Time frame: 1 year

    Mortality in patients undergoing radical cystectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Hazem I Ahmad Sabry, MB,ChB

CONTACT

[email protected]

01062718827

Mohammad Hazem I Sabry

CONTACT

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Important dates

Study start
2028
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2019
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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