Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy

Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy and Ileal Neobladder: A Prospective Randomized Comparative Study

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

Study Overview

• Status: Recruiting
• Conditions: Radical Cystectomy
• Intervention / Treatment: Procedure: suspension uretheroileal technique; Procedure: conventional radical cystectomy and ileal neobladder

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdelrahman m abdellah, assistant lecturer; Phone Number: +201014649841; Email: abdelrahman.ahmed1@med.shag.edu.eg
• Study Contact Backup: Name: ahmed m mohamed, lecturer

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: : group (A) 30 patients will be treated with suspension uretheroileal technique	Procedure: suspension uretheroileal technique; 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
Active Comparator: group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladder	Procedure: conventional radical cystectomy and ileal neobladder; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated	Urinary continence after urethroileal suspension technique	at 1, 3, 6 and 12 months after the procedure will be evaluated

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: soh-med-25-1-1MD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No