Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881642
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-04-25
Brief Title:
Robot-assisted Function-sparing Cystectomy Followed by Modified Orthotopic Ileal Neobladder
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Robot-assisted Cystectomy With Prostate and Seminal-sparing Technique Followed by Modified Orthotopic Ileal Neobladder
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Interventional grouppatients undergoing transurethral resection and enucleation of the prostate first do not open the bladder neck to maintain the integrity of the bladder neck The enucleated prostate capsule and seminal vesicle are preserved under robotic surgery and the urinary catheter is stretched during the operation to avoid implantation and metastasis
Conventional grouppatients undergoing conventional robotic radical cystoprostatectomy All the patients undergoing cystectomy and accept at least 12 months follow up
Followup Each patient was evaluated at 3-month intervals for 1 year at 6- month intervals for 2 to 3 years Renal ultrasound biochemical examination and urine culture were done every 3 to 6 months Pelvic computerized tomography and retro-cystogram were performed 6 months postoperatively and annually thereafter Urodynamic investigation and cystoscopic examination were done annually
Postoperative complications were classified as early 90 days or less and late greater than 90 days Early and late complications were subdivided into those related and not related to the neobladder Major complications were defined as grade III or higher
Daytime and nighttime continence levels were recorded postoperatively at patient interview Continence was defined as complete if the patient was dry without a pad satisfactory if no more than 1 pad was required and poor if the patient used more than 1 pad during the day or night
Conventional grouppatients undergoing conventional robotic radical cystoprostatectomy All the patients undergoing cystectomy and accept at least 12 months follow up
Followup Each patient was evaluated at 3-month intervals for 1 year at 6- month intervals for 2 to 3 years Renal ultrasound biochemical examination and urine culture were done every 3 to 6 months Pelvic computerized tomography and retro-cystogram were performed 6 months postoperatively and annually thereafter Urodynamic investigation and cystoscopic examination were done annually
Postoperative complications were classified as early 90 days or less and late greater than 90 days Early and late complications were subdivided into those related and not related to the neobladder Major complications were defined as grade III or higher
Daytime and nighttime continence levels were recorded postoperatively at patient interview Continence was defined as complete if the patient was dry without a pad satisfactory if no more than 1 pad was required and poor if the patient used more than 1 pad during the day or night
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None