Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

Study Overview
=================
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.

Official Title
-----------------
Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: lateral prostate capsule sparing or neurovascular bundles sparing


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lateral prostate capsule sparing group<br>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<br>* When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.<br>|
| Active Comparator: nerve sparing group<br>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<br>* When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day-time continence rate | Patients were considered continent when they required 0 or 1 safety pad during the day time | 6 months | 
| night-time continence rate | Patients were considered continent when they required 0 or 1 safety pad during the night. | 6 months | 
| postoperative sexual function | The sexual function are evaluated by the international index of erectile function-5 (IIEF-5). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative complication rate |  | 3 months | 
| operative time |  | 24 hours | 
| estimated blood loss |  | 24 hours | 
| overall survival |  | 1 year | 
| recurrence-free survival |  | 1 year |