Bladder CancerPhase 3NCT04939194
Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
A Phase 3 study testing Fast Track Protocol in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
We will design a randomized controlled single center study in which we will compare 2 groups of patients, 1 with standard perioperative protocols and another one in which we will apply fast track protocols in patients after radical cystectomy and urinary diversion . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Fast Track Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2021to 1 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit
Who cannot join
- Radical cystectomy performed in an emergency setting
- Patients who refused fast track protocol
- Mental illnesses
Trial locations and contacts
1 site in 1 country.
About this study
We will design a randomized controlled single center study in which we will compare 2 groups of patients, 1 with standard perioperative protocols and another one in which we will apply fast track protocols in patients after radical cystectomy and urinary diversion .
Read the detailed description
Study hypothesis:
Fast Track Protocol after Radical Cystectomy reduces the length of hospital stay and the early postoperative complications relative to the traditional perioperative care regimen.
Purpose of the study:
- To evaluate the the perioperative efficacy, safety and benefits of fast track protocol implementation after radical cystectomy and to optimize perioperative patient care for the benefit of "fast-track" surgery.
- To evaluate early complications in patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion.
Study groups:
Group 1: Fast Track group (105 patients). Group 2: Conventional perioperative care group (105 patients).
Study design:
The design of the research will be a prospective randomised, open-label, controlled study on 210 consecutive patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion. All the patients will sign an informed consent. Length of stay, dietary issues, and return of bowel function, readmission rates and complications will be evaluated.
Study setting/location:
The study will be conducted in a single tertiary centre, Urology and Nephrology Centre in Mansoura, Egypt. The study will be carried out on patient with bladder cancer who will be subjected to radical cystectomy and urinary diversion.
Study duration:
The study will last about 2 and half years.
Randomisation:
Randomization will be performed using computer generated, sequentially numbered random tables. Ratio of assignment to groups is 1: 1.
Allocation concealment and blinding:
We are well aware that it is very difficult to properly blind trials comparing surgical treatments. Allocation of patients to treatment groups will be self-evident following randomization and blinding of patient groups and observers will not be possible. So, our trial will be a randomised, open-label, controlled trial.
Type of analysis:
Intention-to-treat analysis is planned in this trial. We will include all patients randomized to the fast track group regardless of their adherence and compliance to the early recovery after surgery (ERAS) items.
- Conditions
- Bladder Cancer
- Being tested
- Fast Track Protocol
- Keywords
- ERAS (Early Recovery After Surgery), Radical Cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Track ProtocolBehavioural
We will apply 22 items of ERAS society
| Study group | Role | What they receive |
|---|---|---|
| Fast Track Protocol | Experimental | the 22 items of ERAS (Early Recovery After Surgery) society Receives: Behavioral: Fast Track Protocol |
| Conventional perioperative care program | No intervention | standard perioperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay.
Mean length of hospital stay defined as days from admission to the hospital, in both groups 1 day before surgery and discharge.
Measured: 3 months after surgery.
Secondary outcomes (2)
Early postoperative complications rate defined and graded according to Clavien-Dindo system.
Rate of early postoperative complications eg: anastomotic leakage, intestinal obstruction, wound infection.
Measured: 3 months after surgery.
Hospital readmission rate.
Measured: 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start15 Jan 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Lashin, Mansoura University
- Investigators
- Ahmed Mosbah, Prof., Study chair, Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, EgyptMahmoud Laymon, Lecturer., Study director, Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, EgyptAhmed Lashin, Dr., Principal investigator, Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939194
- Sponsor's protocol ID
- UNC , Mansoura
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04939194
- Acronym / sponsor ID
- UNC , Mansoura
- Conditions
- Bladder Cancer
- Keywords
- ERAS (Early Recovery After Surgery), Radical Cystectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 25 Jun 2021 (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.
We will design a randomized controlled single center study in which we will compare 2 groups of patients, 1 with standard perioperative protocols and another one in which we will apply fast track protocols in patients after radical cystectomy and urinary diversion .
Detailed description
Study hypothesis:
Fast Track Protocol after Radical Cystectomy reduces the length of hospital stay and the early postoperative complications relative to the traditional perioperative care regimen.
Purpose of the study:
- To evaluate the the perioperative efficacy, safety and benefits of fast track protocol implementation after radical cystectomy and to optimize perioperative patient care for the benefit of "fast-track" surgery.
- To evaluate early complications in patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion.
Study groups:
Group 1: Fast Track group (105 patients). Group 2: Conventional perioperative care group (105 patients).
Study design:
The design of the research will be a prospective randomised, open-label, controlled study on 210 consecutive patients with bladder cancer who will be subjected to radical cystectomy and urinary diversion. All the patients will sign an informed consent. Length of stay, dietary issues, and return of bowel function, readmission rates and complications will be evaluated.
Study setting/location:
The study will be conducted in a single tertiary centre, Urology and Nephrology Centre in Mansoura, Egypt. The study will be carried out on patient with bladder cancer who will be subjected to radical cystectomy and urinary diversion.
Study duration:
The study will last about 2 and half years.
Randomisation:
Randomization will be performed using computer generated, sequentially numbered random tables. Ratio of assignment to groups is 1: 1.
Allocation concealment and blinding:
We are well aware that it is very difficult to properly blind trials comparing surgical treatments. Allocation of patients to treatment groups will be self-evident following randomization and blinding of patient groups and observers will not be possible. So, our trial will be a randomised, open-label, controlled trial.
Type of analysis:
Intention-to-treat analysis is planned in this trial. We will include all patients randomized to the fast track group regardless of their adherence and compliance to the early recovery after surgery (ERAS) items.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast Track Protocol | Experimental | Behavioral: Fast Track Protocolthe 22 items of ERAS (Early Recovery After Surgery) society |
| Conventional perioperative care program | No intervention | –standard perioperative care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit
Key exclusion criteria (3 listed)
- Radical cystectomy performed in an emergency setting
- Patients who refused fast track protocol
- Mental illnesses
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 |
|---|---|---|
| Fast Track ProtocolWe will apply 22 items of ERAS society | Behavioural | Fast Track Protocol |
Primary outcome
Length of hospital stay.
Time frame: 3 months after surgery.
Mean length of hospital stay defined as days from admission to the hospital, in both groups 1 day before surgery and discharge.
2 secondary outcomes
Early postoperative complications rate defined and graded according to Clavien-Dindo system.
Time frame: 3 months after surgery.
Hospital readmission rate.
Time frame: 3 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- 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. This study is not recruiting at the moment.
Ahmed Mosbah, Prof. study chair
Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
Mahmoud Laymon, Lecturer. study director
Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
Ahmed Lashin, Dr. principal investigator
Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fast Track Protocol in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay. (time frame: 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2021.