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

• Conditions: Bladder Cancer
• Interventions: Procedure: pelvic reconstruction

• Registration Number: NCT04958343
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

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 Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-02
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
reconstruction group	pelvic reconstruction	Patients will receive pelvic reconstruction following radical cystectomy during the operation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
operative time	24 hours
overall survival	1 year
perioperative complication rate	3 months
recurrence-free survival	1 year
estimated blood loss	24 hours

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China