Radical CystectomyNCT06783855
Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy
A study testing suspension uretheroileal technique and conventional radical cystectomy and ileal neobladder in people with Radical Cystectomy, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radical Cystectomy
- What is being tested?
- suspension uretheroileal technique and conventional radical cystectomy and ileal neobladder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- NMIBC or benign disease.
- Severe hepatic renal dysfunction.
- Urethral involvement with bladder carcinoma.
- Poor overall health status.
- Severe renal dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed m mohamed, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
magdy m amin, professor
About this study
Official title: 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
Read the 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
- Conditions
- Radical Cystectomy
- Being tested
- suspension uretheroileal technique, conventional radical cystectomy and ileal neobladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspension uretheroileal techniqueProcedure or surgery
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
conventional radical cystectomy and ileal neobladderProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| : group (A) 30 patients will be treated with suspension uretheroileal technique | Active comparator | Not described Receives: Procedure: suspension uretheroileal technique |
| group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladder | Active comparator | Not described Receives: Procedure: conventional radical cystectomy and ileal neobladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated
Urinary continence after urethroileal suspension technique
Measured: at 1, 3, 6 and 12 months after the procedure will be evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical CystectomyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdellah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783855
- Sponsor's protocol ID
- soh-med-25-1-1MD
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Uretheroileal Suspension Technique During Open Radical Cystectomy and Ileal Neobladder: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06783855
- Acronym / sponsor ID
- soh-med-25-1-1MD
- Conditions
- Radical Cystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| : 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age >18 years.
- Muscle-invasive bladder carcinoma (MIBC).
- Non-muscle-invasive bladder carcinoma (NMIBC) fulfilling the following criteria:
Key exclusion criteria (5 listed)
- NMIBC or benign disease.
- Severe hepatic renal dysfunction.
- Urethral involvement with bladder carcinoma.
- Poor overall health status.
- Severe renal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suspension uretheroileal techniqueThe 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 | Procedure or surgery | : group (A) 30 patients will be treated with suspension uretheroileal technique |
| conventional radical cystectomy and ileal neobladderAfter 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 | Procedure or surgery | group (B) 30 patients will be treated with conventional radical cystectomy and ileal neobladder |
Primary outcome
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated
Time frame: at 1, 3, 6 and 12 months after the procedure will be evaluated
Urinary continence after urethroileal suspension technique
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ahmed m mohamed, lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suspension uretheroileal technique and conventional radical cystectomy and ileal neobladder in people with Radical Cystectomy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact abdelrahman m abdellah, assistant lecturer (+201014649841, abdelrahman.ahmed1@med.shag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The continence rates at 1, 3, 6 and 12 months after the procedure will be evaluated (time frame: at 1, 3, 6 and 12 months after the procedure will be evaluated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.