Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center

NCT ID: NCT04838873

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-24

Study Completion Date

2020-12-30

Brief Summary

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

Detailed Description

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The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.

Conditions

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Bladder Cancer Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Radical Cystectomy

Standard open radical cystectomy.

Group Type ACTIVE_COMPARATOR

Open radical cystectomy

Intervention Type PROCEDURE

Standard open radical cystectomy and urinary diversion

Laparoscopic-assisted radical cystectomy.

Laparoscopic-assisted radical cystectomy.

Group Type EXPERIMENTAL

Laparoscopic-assisted radical cystectomy

Intervention Type PROCEDURE

Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion

Interventions

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Open radical cystectomy

Standard open radical cystectomy and urinary diversion

Intervention Type PROCEDURE

Laparoscopic-assisted radical cystectomy

Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelbary Ali

Lecturer of Surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hatem Aboulkassem, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Cairo University

Locations

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National Cancer Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SO1901-31004

Identifier Type: -

Identifier Source: org_study_id

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