DeliriumNCT03806439
Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
An observational study of Delirium and Radical Cystectomy, run by University of Alexandria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Delirium, Radical Cystectomy
- What is being tested?
- Radical cystectomy.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2028to 24 Nov 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing radical cystectomy.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammad Hazem I Sabry contact
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.
Read the 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.
- Conditions
- Delirium, Radical Cystectomy
- Being tested
- Radical cystectomy.
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical cystectomy.Other
Adult patients undergoing radical cystectomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radical cystectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Post-surgical delirium in patients undergoing radical cystectomy.
Measured: 1 year
Secondary outcomes (1)
Mortality
Mortality in patients undergoing radical cystectomy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start25 Nov 2028 (estimated)
- Primary completion24 Nov 2029 (estimated)
- Study completion24 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hazem I. Ahmad Sabry, University of Alexandria
- Investigators
- Mohammad Hazem I Ahmad Sabry, MB,ChB MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806439
- Sponsor's protocol ID
- 16/71(8/2/2017)
- Status last verified
- Mar 2025
- First submitted
- 5 Jan 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raats JW, van Eijsden WA, Crolla RM, Steyerberg EW, van der Laan L. Risk Factors and Outcomes for Postoperative Delirium after Major Surgery in Elderly Patients. PLoS One. 2015 Aug 20;10(8):e0136071. doi: 10.1371/journal.pone.0136071. eCollection 2015.
PubMed 26291459
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-surgical Delirium in Patients Undergoing Radical Cystectomy.
- ClinicalTrials.gov ID
- NCT03806439
- Acronym / sponsor ID
- 16/71(8/2/2017)
- Conditions
- Delirium, Radical Cystectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 25 Nov 2028 (estimated)
- Primary completion
- 24 Nov 2029 (estimated)
- Study completion
- 24 Nov 2029 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radical cystectomy. | – | Other: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing radical cystectomy.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical cystectomy.Adult patients undergoing radical cystectomy. | Other | Patients undergoing radical cystectomy. |
Primary outcome
Delirium
Time frame: 1 year
Post-surgical delirium in patients undergoing radical cystectomy.
1 secondary outcome
Mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 26291459Raats JW, van Eijsden WA, Crolla RM, Steyerberg EW, van der Laan L. Risk Factors and Outcomes for Postoperative Delirium after Major Surgery in Elderly Patients. PLoS One. 2015 Aug 20;10(8):e0136071. doi: 10.1371/journal.pone.0136071. eCollection 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Hazem I Sabry contact
Mohammad Hazem I Ahmad Sabry, MB,ChB MD principal investigator
Alexandria University
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Radical Cystectomy, run by University of Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Hazem I Ahmad Sabry, MB,ChB (01062718827, mohammad_hazem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.