Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Sepsis
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Detailed 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.
Investigators
Ahmed Abdelbary Ali
Lecturer of Surgical Oncology
Cairo University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Sepsis
Time Frame: Up to 4 weeks
Infection triggering a systematic immune response
Operative time
Time Frame: During surgery
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Visceral injury
Time Frame: During surgery
Any organ injury encountered during the operation.
Urine leak
Time Frame: Up to 4 weeks
Leakage of urine from urinary enteric anastomosis
Wound dehiscence, infection.
Time Frame: Up to 4 weeks
Wound gaping, evisceration or infection.
Venous thromboembolism
Time Frame: Up to 2 months
DVT or pulmonary embolism
Blood loss
Time Frame: During surgery
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Time to oral intake
Time Frame: Immediate post-operative period
Measured in days
Conversion rate
Time Frame: During surgery
Rate of conversion from laparoscopy to open surgery
Re-admission rate.
Time Frame: Intra-operative to sixth months.
Re-hospitalization requirement.
Opioid requirements.
Time Frame: During surgery through first post-operative week.
Requirement, dose and duration of narcotic analgesia.
Length of hospital stay
Time Frame: Immediate post-operative period.
LOS as measured in days
Enteric fistula
Time Frame: Up to 4 weeks
Leakage of intestinal contents due to failure of entero-enteric anastomosis
Secondary Outcomes
- Lymph node retrieval(Within 10 days post surgery.)
- pN stage(Within 10 days post surgery.)
- pT stage(Within 10 days post surgery.)
- Surgical margins(Within 10 days post surgery)
- Histological grade(Within 10 days post surgery)