Robot-assisted Function-sparing Cystectomy Followed by Modified Orthotopic Ileal Neobladder

NCT05881642 | Recruiting

• 1 other identifier: 0857-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

With the same tumor control rate as classic radical cystectomy, radical cystectomy with partial preservation of the prostate and seminal vesicle can effectively preserve penile erection and fertility, improve urinary control rate and shorten hospitalization time. In this project, transurethral resection of the prostate was used to remove part of the prostate, which further reduced the trauma of radical cystectomy and better preserved the nerves and urethral sphincter. Rapid intraoperative examination of resected tissue can provide a basis for the selection of surgical options. Robot-assisted radical cystectomy can perform pelvic lymph node dissection more accurately, preserve neurovascular complex more effectively, and improve the control effect of tumor and the protective effect of sexual function and reproductive function. In view of the shortcomings of the internationally accepted orthotopic ileal neobladder, this study improved the operation according to the physiological and anatomical characteristics, restored the orthophoria of the new bladder, maintained the consistency of physiological anatomy, and minimized the bladder pressure.

Conditions

Negative Surgical Margins

Outcome Measures

Primary Outcomes (1)

• Post-operative urinary function

  Assess post-operative urinary function

  During each follow-up postoperatively, the assessment is evaluated 36 months postoperatively

Secondary Outcomes (2)

• bladder cancer specific survival rate

  During each follow-up postoperatively, the assessment is calculated based on the 36 months result postoperatively

• Sexual function

  During each follow-up postoperatively, the assessment is calculated based on the BCI score of 36 months postoperatively

Study Arms (2)

Prostate and seminal-sparing Cystectomy

EXPERIMENTAL

Patients undergoing transurethral resection and enucleation of the prostate before robot-assisted cystectomy

Procedure: Prostate and seminal-sparing Cystectomy

Conventional Radical Cystoprostatectomy

PLACEBO COMPARATOR

Patients undergoing conventional robot-assisted radical cystoprostatectomy

Procedure: Conventional Radical Cystoprostatectomy

Interventions

Prostate and seminal-sparing Cystectomy PROCEDURE

Adopt endoscopic enucleation technology to preserve the prostate capsule and part of the urinary control support structure to help restore urinary control and erectile functions

Prostate and seminal-sparing Cystectomy

Conventional Radical Cystoprostatectomy PROCEDURE

According to the consensus standard program, remove the accessory tissues including the bladder,prostate and seminal vesicles

Conventional Radical Cystoprostatectomy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: only male patient have prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Muscle invasive or recurrent multiple non-muscle invasive bladder cancer patients
• Invasive bladder cancer patients without invasion of the triangle and posterior urethra
• Age \< 70 years old, urethral sphincter function is good
• Male patients with serum prostate specific antigen \< 4ug / L

You may not qualify if:

• Possible recurrence of urethra after cystectomy
• Patients with bladder adenocarcinoma and squamous cell carcinoma should not undergo orthotopic neobladder.
• Patients with renal insufficiency
• Severe liver dysfunction
• Severe intestinal diseases ( Crohn 's disease, short bowel syndrome )
• Preoperative tumor breaks through the bladder and invades the surrounding tissue
• urethral stricture cannot pass through the resectoscope

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union hospital,Tongji medical college, Huazhong university of science and techonology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Margins of Excision

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoping Zhang

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoping Zhang

CONTACT

+86-027-85351625; xzhang@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)