Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy and Ileal Neobladder: A Prospective Randomized Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sohag University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated
Study Overview
Brief Summary
The suspension technique is reported as the puboprostatic ligaments that attach the prostate to the symphysis pubis. After the ligating the complex, including both the dorsal vein complex and the puboprostatic ligaments, this complex was sharply divided anteriorly from the prostate with a safe distance (1-2 mm), and the urethra is defined and divided. After removing the prostate, the ileal pouch is reconstructed by completely everting the mucosa and sutured outward with a running 4-0 absorbable suture around the edge. The neck of the neobladder was narrowed to ≈1 cm, for convenient passage of a 20 F catheter. Anastomotic sutures of 3-0 absorbable polyglactin were placed at the 1, 3, 5, 6, 7, 9, 11 and 12 o'clock positions
Detailed Description
The suspension technique is reported as the puboprostatic ligaments that attach the prostate to the symphysis pubis. After the ligating the complex, including both the dorsal vein complex and the puboprostatic ligaments, this complex was sharply divided anteriorly from the prostate with a safe distance (1-2 mm), and the urethra is defined and divided. After removing the prostate, the ileal pouch is reconstructed by completely everting the mucosa and sutured outward with a running 4-0 absorbable suture around the edge. The neck of the neobladder was narrowed to ≈1 cm, for convenient passage of a 20 F catheter. Anastomotic sutures of 3-0 absorbable polyglactin were placed at the 1, 3, 5, 6, 7, 9, 11 and 12 o'clock positions through the full thickness of the urethra, including the mucosa and muscularis of the neobladder neck, ensuring mucosa-to-mucosa anastomosis. The sutures at the 1 and 11 o'clock positions were anchored to the ligated complex including both the dorsal vein complex and the puboprostatic ligaments, to suspend the poucho-urethral anastomosis (suspension technique). The difference between the suspension and no-suspension techniques is only the placing of two sutures into the ligated complex
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient age >18 years.
- •Muscle-invasive bladder carcinoma (MIBC).
- •Non-muscle-invasive bladder carcinoma (NMIBC) fulfilling the following criteria:
- •(recurrent disease that is unresponsive to other treatments
- •high-grade tumors (T1, carcinoma in situ) refractory to intravesical therapy
- •Multifocal or recurrent high-grade tumors despite intravesical therapy and the tumor progression from NMIBC to MIBC).
Exclusion Criteria
- •NMIBC or benign disease.
- •Severe hepatic renal dysfunction.
- •Urethral involvement with bladder carcinoma.
- •Poor overall health status.
- •Severe renal dysfunction.
Arms & Interventions
: group (A) 30 patients will be treated with suspension uretheroileal technique
Intervention: suspension uretheroileal technique (Procedure)
group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladder
Intervention: conventional radical cystectomy and ileal neobladder (Procedure)
Outcomes
Primary Outcomes
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated
Time Frame: at 1, 3, 6 and 12 months after the procedure will be evaluated
Urinary continence after urethroileal suspension technique
Secondary Outcomes
No secondary outcomes reported
Investigators
Abdelrahman Mohamed Abdellah
assistant lecturer urology department sohag university hospital
Sohag University