Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedAugust 24, 2021
July 1, 2021
2 years
July 9, 2021
August 22, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
perioperative complication rate
3 months
operative time
24 hours
estimated blood loss
24 hours
overall survival
1 year
recurrence-free survival
1 year
Study Arms (2)
nerve sparing group
Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.
non nerve sparing group
Patients will receive standard radical cystectomy (not preserve the neurovascular bundles) during the operation.
Interventions
When resect the bladder and prostate, the neurovascular bundles around the prostate will be preserved.
Eligibility Criteria
Enroll patients who received RARC.
You may qualify if:
- Male patients aged 18 or older.
- Patients those who are diagnosed with urothelial carcinoma.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Huang, MD
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
August 24, 2021
Study Start
October 1, 2021
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
August 24, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share