Bladder Cancer
Conditions
Brief summary
To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.
Detailed description
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.
Interventions
PROCEDURElateral prostate capsule sparing or neurovascular bundles sparing
When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
The Seventh Affiliated Hospital of Sun Yat-sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male patients aged 18 or older. 2. Patients those who are diagnosed with urothelial carcinoma. 3. Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA\<2.5ng/ml. 4. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder. 5. Patients those who are able to cooperate and complete the follow-up. 6. Patients those who volunteer to participate in this study and sign the informed consens.
Exclusion criteria
1. Patients thsoe who are diagnosed distant metastasis before surgery. 2. Patients those who are diagnosed with other malignancies. 3. Patients those who had received pelvic radiotherapy or major pelvic operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| day-time continence rate | 6 months | Patients were considered continent when they required 0 or 1 safety pad during the day time |
| night-time continence rate | 6 months | Patients were considered continent when they required 0 or 1 safety pad during the night. |
| postoperative sexual function | 6 months | The sexual function are evaluated by the international index of erectile function-5 (IIEF-5). |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 1 year |
| perioperative complication rate | 3 months |
| recurrence-free survival | 1 year |
| operative time | 24 hours |
| estimated blood loss | 24 hours |
Countries
China
Contacts
Primary ContactKaiwen Li, MD
Backup ContactJian Huang, MD
Outcome results
None listed