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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Radical Cystectomy | Active Comparator | Standard open radical cystectomy. |
|
| Laparoscopic-assisted radical cystectomy. | Experimental | Laparoscopic-assisted radical cystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open radical cystectomy | Procedure | Standard open radical cystectomy and urinary diversion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion. | During surgery |
| Blood loss | EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs. | During surgery |
| Length of hospital stay | LOS as measured in days | Immediate post-operative period. |
| Time to oral intake | Measured in days | Immediate post-operative period |
| Conversion rate | Rate of conversion from laparoscopy to open surgery | During surgery |
| Re-admission rate. | Re-hospitalization requirement. | Intra-operative to sixth months. |
| Opioid requirements. | Requirement, dose and duration of narcotic analgesia. | During surgery through first post-operative week. |
| Visceral injury | Any organ injury encountered during the operation. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| pT stage | Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4) | Within 10 days post surgery. |
| Lymph node retrieval | Number of lymph nodes retrieved by open versus laparoscopic approaches. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hatem Aboulkassem, M.D., Ph.D. | National Cancer Institute, Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | 11796 | Egypt |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Laparoscopic-assisted radical cystectomy | Procedure | Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion |
|
| Urine leak | Leakage of urine from urinary enteric anastomosis | Up to 4 weeks |
| Wound dehiscence, infection. | Wound gaping, evisceration or infection. | Up to 4 weeks |
| Enteric fistula | Leakage of intestinal contents due to failure of entero-enteric anastomosis | Up to 4 weeks |
| Sepsis | Infection triggering a systematic immune response | Up to 4 weeks |
| Venous thromboembolism | DVT or pulmonary embolism | Up to 2 months |
| Within 10 days post surgery. |
| pN stage | Lymph node metastasis (positive or negative), and number of positive nodes if present. | Within 10 days post surgery. |
| Surgical margins | Positive margins or negative margins. Location of positive margins (Urethral, ureteric) | Within 10 days post surgery |
| Histological grade | Low grade, intermediate grade or high grade | Within 10 days post surgery |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |