Orthotopic NeobladdersNCT05673044
Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
A study testing modified Studer ileal neobladder in people with Orthotopic Neobladders, run by Assiut University at 1 site in Egypt.
Trial summary
Bladder cancer is the most common malignant neoplasm of the urinary system. Neoadjuvant chemotherapy followed by radical cystectomy (RC) is the standard treatment for Muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthotopic Neobladders
- What is being tested?
- modified Studer ileal neobladder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with muscle invasive bladder cancer (T2-3N0-1M0).
- Patients with T1 high grade bladder cancer with failed intravesical immunotherapy.
- Bladder neck area including the trigone free from cancerous involvement.
- Patients accepting the operation who are medically fit.
Who cannot join
- Patients with serum creatinine ≥ 1.8 mg/dl.
- Patients with intestinal disorders including previous bowel resections, severe diverticulosis or inflammatory bowel disease.
- Inability to do perform clean intermittent catheterization (CIC) due to physical or mental impairment.
- Sphincteric deficiency or urethral stricture disease causing voiding dysfunction.
- Positive prostatic urethral biopsy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit university
Asyut, Assuit, 71511
Abdelrahman Atef Ali, M.D, 01000318832, kartel_king007@yahoo.com
About this study
Bladder cancer is the most common malignant neoplasm of the urinary system. Neoadjuvant chemotherapy followed by radical cystectomy (RC) is the standard treatment for Muscle invasive bladder cancer.
Studer neobladder is one of the commonly used techniques for orthotopic reconstruction, originally utilizing 60-65 cm of the ileum. However, this leads to formation of a flaccid reservoir.
Read more
Nowadays, most techniques use 40-45 cm ileal segment only due to the proven increased reservoir capacity over time. So Moeen et al developed a modified Studer ileal neobladder by using a shorter ileal segment (40 cm only).
Upper urinary tract protection is important in neobladder reconstruction. One of the proposed anti-reflux techniques is using an isoperistaltic limp which was about 20 cm. This segment will be compressed by the elevated intra-abdominal pressure during Valsalva voiding to prevent reflux. However, this length was subjected to multiple reductions in multiple studies. Moeen et al used an 8 cm straight isoperistaltic ileal chimney.
In spiral neobladder the ureters are implanted into the reservoir using a non-refluxing split-cuff nipple technique. It has good functional and urodynamic parameters. Moeen et al added 8 cm as RT sided angled chimney over the neobladder. The ureters were implanted directly in an end to side manner. They assumed that adding this angulation to this short chimney decreases reflux and protect the UUT, without adding time to develop an anti-reflux technique.
- Conditions
- Orthotopic Neobladders
- Being tested
- modified Studer ileal neobladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Studer ileal neobladderProcedure or surgery
Also called modified spiral ileal neobladder
orthotopic ileal neobladders
| Study group | Role | What they receive |
|---|---|---|
| modified Studer ileal neobladder | Experimental | the segment of the iso-peristaltic segment is 8 cm and the total length of the ileum used is 40 cm instead of 60 cm. Receives: Procedure: modified Studer ileal neobladder |
| modified spiral ileal neobladder | Experimental | the chimney of the spiral neobladder will be an angled one instead of straight. Receives: Procedure: modified Studer ileal neobladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of the reservoir capacity
Assessment of reservoir capacity by pouch size in urodynamics
Measured: At 3rd month post operative
The assessment of the reservoir capacity
Assessment of reservoir capacity by pouch size in urodynamics
Measured: At 6th month post operative
The assessment of the reservoir capacity
Assessment of reservoir capacity by pouch size in urodynamics
Measured: At 12th month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthotopic NeobladdersStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Atef Ali, Assiut University
- Investigators
- Diaa Eldin hameed Sayed, PhD, Study director, cheif of urological oncology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673044
- Sponsor's protocol ID
- Assuituro
- Status last verified
- Jan 2023
- First submitted
- 7 Dec 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
- ClinicalTrials.gov ID
- NCT05673044
- Acronym / sponsor ID
- Assuituro
- Conditions
- Orthotopic Neobladders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 5 Jan 2023 (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.
Bladder cancer is the most common malignant neoplasm of the urinary system. Neoadjuvant chemotherapy followed by radical cystectomy (RC) is the standard treatment for Muscle invasive bladder cancer.
Studer neobladder is one of the commonly used techniques for orthotopic reconstruction, originally utilizing 60-65 cm of the ileum. However, this leads to formation of a flaccid reservoir.
Nowadays, most techniques use 40-45 cm ileal segment only due to the proven increased reservoir capacity over time. So Moeen et al developed a modified Studer ileal neobladder by using a shorter ileal segment (40 cm only).
Upper urinary tract protection is important in neobladder reconstruction. One of the proposed anti-reflux techniques is using an isoperistaltic limp which was about 20 cm. This segment will be compressed by the elevated intra-abdominal pressure during Valsalva voiding to prevent reflux. However, this length was subjected to multiple reductions in multiple studies. Moeen et al used an 8 cm straight isoperistaltic ileal chimney.
In spiral neobladder the ureters are implanted into the reservoir using a non-refluxing split-cuff nipple technique. It has good functional and urodynamic parameters. Moeen et al added 8 cm as RT sided angled chimney over the neobladder. The ureters were implanted directly in an end to side manner. They assumed that adding this angulation to this short chimney decreases reflux and protect the UUT, without adding time to develop an anti-reflux technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Studer ileal neobladder | Experimental | Procedure: modified Studer ileal neobladderthe segment of the iso-peristaltic segment is 8 cm and the total length of the ileum used is 40 cm instead of 60 cm. |
| modified spiral ileal neobladder | Experimental | Procedure: modified Studer ileal neobladderthe chimney of the spiral neobladder will be an angled one instead of straight. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with muscle invasive bladder cancer (T2-3N0-1M0).
- Patients with T1 high grade bladder cancer with failed intravesical immunotherapy.
- Bladder neck area including the trigone free from cancerous involvement.
- Patients accepting the operation who are medically fit.
Key exclusion criteria (5 listed)
- Patients with serum creatinine ≥ 1.8 mg/dl.
- Patients with intestinal disorders including previous bowel resections, severe diverticulosis or inflammatory bowel disease.
- Inability to do perform clean intermittent catheterization (CIC) due to physical or mental impairment.
- Sphincteric deficiency or urethral stricture disease causing voiding dysfunction.
- Positive prostatic urethral biopsy.
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 |
|---|---|---|
| modified Studer ileal neobladderAlso: modified spiral ileal neobladderorthotopic ileal neobladders | Procedure or surgery | modified Studer ileal neobladder, modified spiral ileal neobladder |
Primary outcome
The assessment of the reservoir capacity
Time frame: At 3rd month post operative
Assessment of reservoir capacity by pouch size in urodynamics
The assessment of the reservoir capacity
Time frame: At 6th month post operative
Assessment of reservoir capacity by pouch size in urodynamics
The assessment of the reservoir capacity
Time frame: At 12th month post operative
Assessment of reservoir capacity by pouch size in urodynamics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
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. This study is not recruiting at the moment.
Diaa Eldin hameed Sayed, PhD study director
cheif of urological oncology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Studer ileal neobladder in people with Orthotopic Neobladders, run by Assiut 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 4 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: status not confirmed, as of the sponsor's last update on 5 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Atef Ali, master degree (00201000318832, Abdelrahman_atefuro93@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of the reservoir capacity (time frame: At 3rd month post operative). The study lists 3 primary outcomes in all. 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 5 Jan 2023.