Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
NCT ID: NCT04939194
Last Updated: 2021-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2021-01-15
2023-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radical Cystectomy Versus Tri-Modal Therapy for Treatment of cT2N0M0 Urinary Bladder Transitional Cell Carcinoma
NCT07043790
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
NCT01734798
Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins
NCT05969964
Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial
NCT05146635
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
NCT03148158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. 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.
2. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fast Track Protocol
the 22 items of ERAS (Early Recovery After Surgery) society
Fast Track Protocol
We will apply 22 items of ERAS society
Conventional perioperative care program
standard perioperative care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fast Track Protocol
We will apply 22 items of ERAS society
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Patients who refused fast track protocol
3. Mental illnesses
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Mohammed Lashin
A.M.Lashin
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Mosbah, Prof.
Role: STUDY_CHAIR
Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
Mahmoud Laymon, Lecturer.
Role: STUDY_DIRECTOR
Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
Ahmed Lashin, Dr.
Role: PRINCIPAL_INVESTIGATOR
Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mansoura Urology & Nephrology Center
Al Mansurah, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UNC , Mansoura
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.