Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy
ConditionRadical Cystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSohag University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age >18 years.
Muscle-invasive bladder carcinoma (MIBC).
- (recurrent disease that is unresponsive to other treatments
- high-grade tumors (T1, carcinoma in situ) refractory to intravesical therapy
Disqualifiers
NMIBC or benign disease.
Severe hepatic renal dysfunction.
Urethral involvement with bladder carcinoma.
Poor overall health status.
Trial design
Design model
Parallel
Treatments tested in this trial
suspension uretheroileal technique
Procedure/SurgeryThe 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
conventional radical cystectomy and ileal neobladder
Procedure/SurgeryAfter 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: : group (A) 30 patients will be treated with suspension uretheroileal techniqueActive comparator 1 intervention
Group B: group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladderActive comparator 1 intervention
Trial outcomes
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
Time frame
at 1, 3, 6 and 12 months after the procedure will be evaluatedSponsors and contacts
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Source ClinicalTrials.gov