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NCT03806439 | NOT YET RECRUITING | Delirium


Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
Sponsor:

University of Alexandria

Information provided by (Responsible Party):

Mohammad Hazem I. Ahmad Sabry

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

Delirium

Radical Cystectomy

Intervention/treatment

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
Estimated Enrollment : 100 participants
Official Title : Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
Actual Study Start Date : 2028-11-25
Estimated Primary Completion Date : 2029-11-24
Estimated Study Completion Date : 2029-11-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria:Adult patients undergoing radical cystectomy. -Exclusion Criteria: Patient refusal.
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  • Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

    Location Details

    NCT03806439


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