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

• Conditions: Bladder Cancer
• Interventions: Procedure: nerve sparing

• Registration Number: NCT05018429
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and nerve 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: non nerve sparing group and nerve sparing group. Patient demographic and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-22
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24
• Study Start: 2021-10-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
4. Patients those who are able to cooperate and complete the follow-up.
5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nerve sparing group	nerve sparing	Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
perioperative complication rate	3 months
recurrence-free survival	1 year
estimated blood loss	24 hours
operative time	24 hours
overall survival	1 year

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China