Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy

Not Applicable

Recruiting

• Conditions: Radical Cystectomy

• Registration Number: NCT06783855
• Lead Sponsor: Sohag University

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 Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient age >18 years.

• Muscle-invasive bladder carcinoma (MIBC).

• Non-muscle-invasive bladder carcinoma (NMIBC) fulfilling the following criteria:

  1. • (recurrent disease that is unresponsive to other treatments
  2. • high-grade tumors (T1, carcinoma in situ) refractory to intravesical therapy
  3. -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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated	at 1, 3, 6 and 12 months after the procedure will be evaluated	Urinary continence after urethroileal suspension technique

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt