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

Mansoura University

Status and phase: Unknown; Phase 3

Conditions: Bladder Cancer

Treatments: Behavioral: Fast Track Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04939194

UNC , Mansoura

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Fast Track Protocol

Experimental group

Description:

the 22 items of ERAS (Early Recovery After Surgery) society

Treatment:

Behavioral: Fast Track Protocol

Conventional perioperative care program

No Intervention group

Description:

standard perioperative care