Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Sponsor
University of Alexandria
Study ID
NCT03806439
Status
Not Yet Recruiting

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Conditions

  • Delirium
  • Radical Cystectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Radical cystectomy. — OTHER
    Adult patients undergoing radical cystectomy.

Study Details

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.

Key Dates

First listed
Jan 16, 2019
Start date
Nov 25, 2028
Status verified
Mar 2025
Primary completion
Nov 24, 2029
Completion
Nov 24, 2029

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Delirium [ Time Frame: 1 year ]

Central Contacts

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