Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedJuly 19, 2021
July 1, 2021
2 years
July 9, 2021
July 15, 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)
lateral prostate capsule sparing group
EXPERIMENTALPatients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation.
nerve sparing group
ACTIVE COMPARATORPatients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.
Interventions
When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
Eligibility Criteria
You may qualify if:
- 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.
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
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2021
First Posted
July 19, 2021
Study Start
September 1, 2021
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
July 19, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share