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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: lateral prostate capsule sparing or neurovascular bundles sparing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. 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.
4. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
5. Patients those who are able to cooperate and complete the follow-up.
6. 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lateral prostate capsule sparing group; Patients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation.	Procedure: lateral prostate capsule sparing or neurovascular bundles sparing; When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
Active Comparator: nerve sparing group; Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.	Procedure: lateral prostate capsule sparing or neurovascular bundles sparing; When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
day-time continence rate	Patients were considered continent when they required 0 or 1 safety pad during the day time	6 months
night-time continence rate	Patients were considered continent when they required 0 or 1 safety pad during the night.	6 months
postoperative sexual function	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	1 year
perioperative complication rate	3 months
operative time	24 hours
estimated blood loss	24 hours
recurrence-free survival	1 year

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: SysMU-RARC2

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