Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- day-time continence rate
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
day-time continence rate
Time Frame: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the day-time.
night-time continence rate
Time Frame: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the night.
postoperative sexual function
Time Frame: 6 months
The sexual function are evaluated by the International Index of Erectile Function-5 (IIEF-5).
Secondary Outcomes
- perioperative complication rate(3 months)
- recurrence-free survival(1 year)
- estimated blood loss(24 hours)
- operative time(24 hours)
- overall survival(1 year)