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

Primary Purpose

Bladder Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

lateral prostate capsule sparing or neurovascular bundles sparing

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patients aged 18 or older.
Patients those who are diagnosed with urothelial carcinoma.
Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA<2.5ng/ml.
Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
Patients those who are able to cooperate and complete the follow-up.
Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

Patients thsoe who are diagnosed distant metastasis before surgery.
Patients those who are diagnosed with other malignancies.
Patients those who had received pelvic radiotherapy or major pelvic operation.

Sites / Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lateral prostate capsule sparing group

nerve sparing group

Arm Description

Patients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation.

Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.

Outcomes

Primary Outcome Measures

day-time continence rate

Patients were considered continent when they required 0 or 1 safety pad during the day time

night-time continence rate

Patients were considered continent when they required 0 or 1 safety pad during the night.

postoperative sexual function

The sexual function are evaluated by the international index of erectile function-5 (IIEF-5).

Secondary Outcome Measures

perioperative complication rate

operative time

estimated blood loss

overall survival

recurrence-free survival

Full Information

NCT ID

NCT04966949

First Posted

July 9, 2021

Last Updated

July 15, 2021

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, The Seventh Affiliated Hospital of Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04966949

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the 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, The Seventh Affiliated Hospital of Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

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: nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

lateral prostate capsule sparing group

Arm Type

Experimental

Arm Description

Patients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation.

Arm Title

nerve sparing group

Arm Type

Active Comparator

Arm Description

Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.

Intervention Type

Procedure

Intervention Name(s)

lateral prostate capsule sparing or neurovascular bundles sparing

Intervention Description

When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.

Primary Outcome Measure Information:

Title

day-time continence rate

Description

Patients were considered continent when they required 0 or 1 safety pad during the day time

Time Frame

6 months

Title

night-time continence rate

Description

Patients were considered continent when they required 0 or 1 safety pad during the night.

Time Frame

6 months

Title

postoperative sexual function

Description

The sexual function are evaluated by the international index of erectile function-5 (IIEF-5).

Time Frame

6 months

Secondary Outcome Measure Information:

Title

perioperative complication rate

Time Frame

3 months

Title

operative time

Time Frame

24 hours

Title

estimated blood loss

Time Frame

24 hours

Title

overall survival

Time Frame

1 year

Title

recurrence-free survival

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male patients aged 18 or older. Patients those who are diagnosed with urothelial carcinoma. Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA<2.5ng/ml. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder. Patients those who are able to cooperate and complete the follow-up. Patients those who volunteer to participate in this study and sign the informed consens. Exclusion Criteria: Patients thsoe who are diagnosed distant metastasis before surgery. Patients those who are diagnosed with other malignancies. Patients those who had received pelvic radiotherapy or major pelvic operation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kaiwen Li, MD

Phone

+86-15989252628

likw6@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Huang, MD

Phone

+86-20-81332146

huangj8@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Huang, MD

Organizational Affiliation

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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