Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy

Sohag University

Status: Enrolling

Conditions: Radical Cystectomy

Treatments: Procedure: suspension uretheroileal technique; Procedure: conventional radical cystectomy and ileal neobladder

Study type: Interventional

Funder types: Other

Identifiers

NCT06783855

soh-med-25-1-1MD

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

: group (A) 30 patients will be treated with suspension uretheroileal technique

Active Comparator group

Treatment:

Procedure: suspension uretheroileal technique

group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladder

Active Comparator group

Treatment:

Procedure: conventional radical cystectomy and ileal neobladder