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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 .
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast Track Protocol | Experimental | the 22 items of ERAS (Early Recovery After Surgery) society |
|
| Conventional perioperative care program | No Intervention | standard perioperative care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast Track Protocol | Behavioral | We will apply 22 items of ERAS society |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative complications rate defined and graded according to Clavien-Dindo system. | Rate of early postoperative complications eg: anastomotic leakage, intestinal obstruction, wound infection. | 3 months after surgery. |
| Hospital readmission rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Mosbah, Prof. | Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt | Study Chair |
| Mahmoud Laymon, Lecturer. | Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt | Study Director |
| Ahmed Lashin, Dr. | Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura Urology & Nephrology Center | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3 months after surgery. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |