Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

August 22, 2021 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Enroll patients who received RARC.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
nerve sparing group
Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.
Procedure: nerve sparing
When resect the bladder and prostate, the neurovascular bundles around the prostate will be preserved.
non nerve sparing group
Patients will receive standard radical cystectomy (not preserve the neurovascular bundles) during the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
night-time continence rate
Time Frame: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the night.
6 months
day-time continence rate
Time Frame: 6 months
Patients were considered continent when they required 0 or 1 safety pad during the day-time.
6 months
postoperative sexual function
Time Frame: 6 months
The sexual function are evaluated by the International Index of Erectile Function-5 (IIEF-5).
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1 year
1 year
perioperative complication rate
Time Frame: 3 months
3 months
operative time
Time Frame: 24 hours
24 hours
estimated blood loss
Time Frame: 24 hours
24 hours
recurrence-free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Shantou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

August 22, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SysMU-RARC5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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