NCT04939194

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 16, 2021

Last Update Submit

June 24, 2021

Conditions

Bladder Cancer

Keywords

ERAS (Early Recovery After Surgery)Radical Cystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Early postoperative complications rate defined and graded according to Clavien-Dindo system.

    3 months after surgery.

  • Hospital readmission rate.

    3 months after surgery.

Study Arms (2)

Fast Track Protocol

EXPERIMENTAL

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

Behavioral: Fast Track Protocol

Conventional perioperative care program

NO INTERVENTION

standard perioperative care

Interventions

Fast Track ProtocolBEHAVIORAL

We will apply 22 items of ERAS society

Fast Track Protocol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Radical cystectomy performed in an emergency setting
  • Patients who refused fast track protocol
  • Mental illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Urology & Nephrology Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed Mosbah, Prof.

    Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt

    STUDY CHAIR

  • Mahmoud Laymon, Lecturer.

    Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt

    STUDY DIRECTOR

  • Ahmed Lashin, Dr.

    Urology department , Urology and Nephrology Center , Faculty of Medicine, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A.M.Lashin

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 25, 2021

Study Start

January 15, 2021

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)