Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male

Bladder Cancer Clinical Trial

Official title:

Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04958343
• Other study ID #: SysMU-RARC4
• Status: Not yet recruiting
• Start date: July 2, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Kaiwen Li, MD
• Phone: +86-15989252628
• Email: likw6[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• pelvic reconstruction
After radical cystectomy, the pelvic reconstruction including the ligation of dorsal vascular complex and posterior reconstruction will be performed on patients.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	First Affiliated Hospital, Sun Yat-Sen University, The Seventh Affiliated Hospital of Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	day-time and night-time continence rate	Patients were considered continent when they required 0 or 1 safety pad during the day or at night.	6 months
Secondary	perioperative complication rate		3 months
Secondary	operative time		24 hours
Secondary	estimated blood loss		24 hours
Secondary	overall survival		1 year
Secondary	recurrence-free survival		1 year