Bladder Cancer, Laparoscopy
Conditions
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.
Interventions
PROCEDUREOpen radical cystectomy
Standard open radical cystectomy and urinary diversion
PROCEDURELaparoscopic-assisted radical cystectomy
Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous thromboembolism | Up to 2 months | DVT or pulmonary embolism |
| Visceral injury | During surgery | Any organ injury encountered during the operation. |
| Urine leak | Up to 4 weeks | Leakage of urine from urinary enteric anastomosis |
| Wound dehiscence, infection. | Up to 4 weeks | Wound gaping, evisceration or infection. |
| Enteric fistula | Up to 4 weeks | Leakage of intestinal contents due to failure of entero-enteric anastomosis |
| Sepsis | Up to 4 weeks | Infection triggering a systematic immune response |
| Operative time | During surgery | OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion. |
| Blood loss | During surgery | EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs. |
| Length of hospital stay | Immediate post-operative period. | LOS as measured in days |
| Time to oral intake | Immediate post-operative period | Measured in days |
| Conversion rate | During surgery | Rate of conversion from laparoscopy to open surgery |
| Re-admission rate. | Intra-operative to sixth months. | Re-hospitalization requirement. |
| Opioid requirements. | During surgery through first post-operative week. | Requirement, dose and duration of narcotic analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node retrieval | Within 10 days post surgery. | Number of lymph nodes retrieved by open versus laparoscopic approaches. |
| pN stage | Within 10 days post surgery. | Lymph node metastasis (positive or negative), and number of positive nodes if present. |
| Surgical margins | Within 10 days post surgery | Positive margins or negative margins. Location of positive margins (Urethral, ureteric) |
| Histological grade | Within 10 days post surgery | Low grade, intermediate grade or high grade |
| pT stage | Within 10 days post surgery. | Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4) |
Countries
Egypt
Outcome results
None listed