Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.

Conditions
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Bladder Cancer

Intervention / Treatment
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* Behavioral: Fast Track Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit Exclusion Criteria: Radical cystectomy performed in an emergency setting Patients who refused fast track protocol Mental illnesses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast Track Protocol<br>the 22 items of ERAS (Early Recovery After Surgery) society | Behavioral: Fast Track Protocol<br>* We will apply 22 items of ERAS society<br>|
| No Intervention: Conventional perioperative care program<br>standard perioperative care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 3 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS (Early Recovery After Surgery), Radical Cystectomy