NCT04838873

Brief Summary

This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 24, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 30, 2021

Last Update Submit

April 8, 2021

Conditions

Bladder CancerLaparoscopy

Outcome Measures

Primary Outcomes (13)

  • Operative time

    OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.

    During surgery

  • Blood loss

    EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.

    During surgery

  • Length of hospital stay

    LOS as measured in days

    Immediate post-operative period.

  • Time to oral intake

    Measured in days

    Immediate post-operative period

  • Conversion rate

    Rate of conversion from laparoscopy to open surgery

    During surgery

  • Re-admission rate.

    Re-hospitalization requirement.

    Intra-operative to sixth months.

  • Opioid requirements.

    Requirement, dose and duration of narcotic analgesia.

    During surgery through first post-operative week.

  • Visceral injury

    Any organ injury encountered during the operation.

    During surgery

  • Urine leak

    Leakage of urine from urinary enteric anastomosis

    Up to 4 weeks

  • Wound dehiscence, infection.

    Wound gaping, evisceration or infection.

    Up to 4 weeks

  • Enteric fistula

    Leakage of intestinal contents due to failure of entero-enteric anastomosis

    Up to 4 weeks

  • Sepsis

    Infection triggering a systematic immune response

    Up to 4 weeks

  • Venous thromboembolism

    DVT or pulmonary embolism

    Up to 2 months

Secondary Outcomes (5)

  • pT stage

    Within 10 days post surgery.

  • Lymph node retrieval

    Within 10 days post surgery.

  • pN stage

    Within 10 days post surgery.

  • Surgical margins

    Within 10 days post surgery

  • Histological grade

    Within 10 days post surgery

Study Arms (2)

Open Radical Cystectomy

ACTIVE COMPARATOR

Standard open radical cystectomy.

Procedure: Open radical cystectomy

Laparoscopic-assisted radical cystectomy.

EXPERIMENTAL

Laparoscopic-assisted radical cystectomy.

Procedure: Laparoscopic-assisted radical cystectomy

Interventions

Open radical cystectomyPROCEDURE

Standard open radical cystectomy and urinary diversion

Open Radical Cystectomy
Laparoscopic-assisted radical cystectomyPROCEDURE

Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion

Laparoscopic-assisted radical cystectomy.

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
  • Patients fit for surgery (ECOG Performance Status 0,1).

You may not qualify if:

  • Patients with medical comorbidities that preclude surgical management or minimally invasive techniques.
  • Patients with advanced hydronephrosis or renal failure.
  • Patients refusing surgery.
  • Patients with urinary bladder cancer invading bladder neck or prostatic urethra.
  • Patients with metastatic urinary bladder cancer.
  • Patients who received prior pelvic radiotherapy.
  • Patients refusing randomization and/or participation in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, 11796, 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

  • Hatem Aboulkassem, M.D., Ph.D.

    National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Surgical Oncology

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 9, 2021

Study Start

January 24, 2019

Primary Completion

July 1, 2019

Study Completion

December 30, 2020

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)