This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Standard open radical cystectomy and urinary diversion
Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
National Cancer Institute
Cairo, Egypt
Operative time
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Time frame: During surgery
Blood loss
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Time frame: During surgery
Length of hospital stay
LOS as measured in days
Time frame: Immediate post-operative period.
Time to oral intake
Measured in days
Time frame: Immediate post-operative period
Conversion rate
Rate of conversion from laparoscopy to open surgery
Time frame: During surgery
Re-admission rate.
Re-hospitalization requirement.
Time frame: Intra-operative to sixth months.
Opioid requirements.
Requirement, dose and duration of narcotic analgesia.
Time frame: During surgery through first post-operative week.
Visceral injury
Any organ injury encountered during the operation.
Time frame: During surgery
Urine leak
Leakage of urine from urinary enteric anastomosis
Time frame: Up to 4 weeks
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Wound dehiscence, infection.
Wound gaping, evisceration or infection.
Time frame: Up to 4 weeks
Enteric fistula
Leakage of intestinal contents due to failure of entero-enteric anastomosis
Time frame: Up to 4 weeks
Sepsis
Infection triggering a systematic immune response
Time frame: Up to 4 weeks
Venous thromboembolism
DVT or pulmonary embolism
Time frame: Up to 2 months
pT stage
Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)
Time frame: Within 10 days post surgery.
Lymph node retrieval
Number of lymph nodes retrieved by open versus laparoscopic approaches.
Time frame: Within 10 days post surgery.
pN stage
Lymph node metastasis (positive or negative), and number of positive nodes if present.
Time frame: Within 10 days post surgery.
Surgical margins
Positive margins or negative margins. Location of positive margins (Urethral, ureteric)
Time frame: Within 10 days post surgery
Histological grade
Low grade, intermediate grade or high grade
Time frame: Within 10 days post surgery