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

Cairo University (CU)

Status

Completed

Conditions

Bladder Cancer

Laparoscopy

Treatments

Procedure: Laparoscopic-assisted radical cystectomy

Procedure: Open radical cystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04838873

SO1901-31004

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.