Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: lateral prostate capsule sparing group Patients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation. |
Procedure: lateral prostate capsule sparing or neurovascular bundles sparing
When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
|
| Active Comparator: nerve sparing group Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation. |
Procedure: lateral prostate capsule sparing or neurovascular bundles sparing
When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- perioperative complication rate [3 months]
- operative time [24 hours]
- estimated blood loss [24 hours]
- overall survival [1 year]
- recurrence-free survival [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male patients aged 18 or older.
-
Patients those who are diagnosed with urothelial carcinoma.
-
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.
-
Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
-
Patients those who are able to cooperate and complete the follow-up.
-
Patients those who volunteer to participate in this study and sign the informed consens.
Exclusion Criteria:
-
Patients thsoe who are diagnosed distant metastasis before surgery.
-
Patients those who are diagnosed with other malignancies.
-
Patients those who had received pelvic radiotherapy or major pelvic operation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- First Affiliated Hospital, Sun Yat-Sen University
- Third Affiliated Hospital, Sun Yat-Sen University
- The Seventh Affiliated Hospital of Sun Yat-sen University
Investigators
- Principal Investigator: Jian Huang, MD, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SysMU-RARC2