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

Phase 3

• Conditions: Bladder Cancer
• Interventions: Behavioral: Fast Track Protocol

• Registration Number: NCT04939194
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-15
• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25
• Primary Completion: 2023-01-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients undergoing radical cystectomy and urinary diversion surgery including orthotopic neobladder and ileal loop conduit

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Exclusion Criteria

1. Radical cystectomy performed in an emergency setting
2. Patients who refused fast track protocol
3. Mental illnesses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fast Track Protocol	Fast Track Protocol	the 22 items of ERAS (Early Recovery After Surgery) society

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mansoura Urology & Nephrology Center; 🇪🇬 Mansoura, Egypt