Robot-assisted Function-sparing Cystectomy Followed by Modified Orthotopic Ileal Neobladder (NCT05881642) | Clinical Trial Compass
RecruitingNot Applicable
Robot-assisted Function-sparing Cystectomy Followed by Modified Orthotopic Ileal Neobladder
China20 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range20 Years – 70 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Post-operative urinary function
Timeframe: During each follow-up postoperatively, the assessment is evaluated 36 months postoperatively
Trial details
NCT IDNCT05881642
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology