Clinical trial NCT06783855: Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy
Official title: Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy and Ileal Neobladder: A Prospective Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radical Cystectomy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be conducted on 60 eligible patients The patients will be allocated into 2 groups: group (A) 30 patients will be treated with suspension uretheroileal technique and group (B) 30 patients will be treated without suspension technique act as control.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated
timeFrame: at 1, 3, 6 and 12 months after the procedure will be evaluated
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References: