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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04939194
• Other study ID #: UNC , Mansoura
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: January 15, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Fast Track Protocol
We will apply 22 items of ERAS society

Locations

Country	Name	City	State
Egypt	Mansoura Urology & Nephrology Center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Hospital readmission rate.		3 months after surgery.