Bladder Cancer
Conditions
Keywords
ERAS (Early Recovery After Surgery), Radical Cystectomy
Brief 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 .
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: 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.
Interventions
BEHAVIORALFast Track Protocol
We will apply 22 items of ERAS society
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit
Exclusion criteria
1. Radical cystectomy performed in an emergency setting 2. Patients who refused fast track protocol 3. Mental illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative complications rate defined and graded according to Clavien-Dindo system. | 3 months after surgery. | Rate of early postoperative complications eg: anastomotic leakage, intestinal obstruction, wound infection. |
| Hospital readmission rate. | 3 months after surgery. | — |
Countries
Egypt
Outcome results
None listed