Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
NCT ID: NCT05673044
Last Updated: 2023-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2023-01-01
2024-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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modified Studer ileal neobladder
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.
modified Studer ileal neobladder
orthotopic ileal neobladders
modified spiral ileal neobladder
the chimney of the spiral neobladder will be an angled one instead of straight.
modified Studer ileal neobladder
orthotopic ileal neobladders
Interventions
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modified Studer ileal neobladder
orthotopic ileal neobladders
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with T1 high grade bladder cancer with failed intravesical immunotherapy.
3. Bladder neck area including the trigone free from cancerous involvement.
4. Patients accepting the operation who are medically fit.
Exclusion Criteria
2. Patients with intestinal disorders including previous bowel resections, severe diverticulosis or inflammatory bowel disease.
3. Inability to do perform clean intermittent catheterization (CIC) due to physical or mental impairment.
4. Sphincteric deficiency or urethral stricture disease causing voiding dysfunction.
5. Positive prostatic urethral biopsy.
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Abdelrahman Atef Ali
Assistant lecturer of Urology Assuit University Hospital
Principal Investigators
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Diaa Eldin hameed Sayed, PhD
Role: STUDY_DIRECTOR
cheif of urological oncology department
Locations
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Assuit university
Asyut, Assuit, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Assuituro
Identifier Type: -
Identifier Source: org_study_id
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