Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male
Study Details
Study Description
Brief Summary
To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| reconstruction group Patients will receive pelvic reconstruction following radical cystectomy during the operation. |
Procedure: pelvic reconstruction
After radical cystectomy, the pelvic reconstruction including the ligation of dorsal vascular complex and posterior reconstruction will be performed on patients.
|
| non-reconstruction group Patients will not receive pelvic reconstruction following radical cystectomy during the operation. |
Outcome Measures
Primary Outcome Measures
- day-time and night-time continence rate [6 months]
Patients were considered continent when they required 0 or 1 safety pad during the day or at night.
Secondary Outcome Measures
- perioperative complication rate [3 months]
- operative time [24 hours]
- estimated blood loss [24 hours]
- overall survival [1 year]
- recurrence-free survival [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male patients aged 18 or older.
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Patients those who are diagnosed with urothelial carcinoma.
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Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
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Patients those who are able to cooperate and complete the follow-up.
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Patients those who volunteer to participate in this study and sign the informed consens.
Exclusion Criteria:
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Patients thsoe who are diagnosed distant metastasis before surgery.
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Patients those who are diagnosed with other malignancies.
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Patients those who had received pelvic radiotherapy or major pelvic operation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- First Affiliated Hospital, Sun Yat-Sen University
- Third Affiliated Hospital, Sun Yat-Sen University
- The Seventh Affiliated Hospital of Sun Yat-sen University
Investigators
- Principal Investigator: Jian Huang, MD, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SysMU-RARC4