Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy

NCT06783855 | Recruiting

• 1 other identifier: soh-med-25-1-1MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Radical Cystectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

Procedure: suspension uretheroileal technique

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

ACTIVE COMPARATOR

Procedure: conventional radical cystectomy and ileal neobladder

Interventions

suspension uretheroileal technique PROCEDURE

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

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

conventional radical cystectomy and ileal neobladder PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• NMIBC or benign disease.
• Severe hepatic renal dysfunction.
• Urethral involvement with bladder carcinoma.
• Poor overall health status.
• Severe renal dysfunction.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Central Study Contacts

abdelrahman m abdellah, assistant lecturer

CONTACT

+201014649841; abdelrahman.ahmed1@med.shag.edu.eg

ahmed m mohamed, lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer urology department sohag university hospital

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (1)