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

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 Overview

• Status: Enrolling by invitation
• Conditions: Bladder Cancer
• Intervention / Treatment: Behavioral: Fast Track Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura Urology & Nephrology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed Mosbah, Prof., Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt; Study Director: Mahmoud Laymon, Lecturer., Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt; Principal Investigator: Ahmed Lashin, Dr., Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Radical Cystectomy; ERAS (Early Recovery After Surgery)
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: UNC , Mansoura

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No