Clinical trial NCT04939194: Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
Official title: Fast Track Protocol After Radical Cystectomy and Urinary Diversion: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: ERAS (Early Recovery After Surgery)
Radical Cystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay.
timeFrame: 3 months after surgery.
Secondary outcomes:
measure: Early postoperative complications rate defined and graded according to Clavien-Dindo system.
timeFrame: 3 months after surgery.
measure: Hospital readmission rate.
timeFrame: 3 months after surgery.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Urology & Nephrology Center
Study officials:
affiliation: Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
name: Ahmed Mosbah, Prof.
role: STUDY_CHAIR
affiliation: Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
name: Mahmoud Laymon, Lecturer.
role: STUDY_DIRECTOR
affiliation: Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt
name: Ahmed Lashin, Dr.
role: PRINCIPAL_INVESTIGATOR
References: