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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04958343
Enrollment
100
Registered
2021-07-12
Start date
2021-07-02
Completion date
2023-07-01
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

PROCEDUREpelvic reconstruction

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
day-time and night-time continence rate6 monthsPatients were considered continent when they required 0 or 1 safety pad during the day or at night.

Secondary

MeasureTime frame
perioperative complication rate3 months
operative time24 hours
estimated blood loss24 hours
overall survival1 year
recurrence-free survival1 year

Countries

China

Contacts

Primary ContactKaiwen Li, MD
likw6@mail.sysu.edu.cn+86-15989252628
Backup ContactJian Huang, MD
huangj8@mail.sysu.edu.cn+86-20-81332146

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026