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Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.

Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05673044
Enrollment
52
Registered
2023-01-05
Start date
2023-01-01
Completion date
2024-12-15
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthotopic Neobladders

Brief 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. 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.

Interventions

PROCEDUREmodified Studer ileal neobladder

orthotopic ileal neobladders

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with muscle invasive bladder cancer (T2-3N0-1M0). 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

1. Patients with serum creatinine ≥ 1.8 mg/dl. 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.

Design outcomes

Primary

MeasureTime frameDescription
The assessment of the reservoir capacityAt 3rd month post operativeAssessment of reservoir capacity by pouch size in urodynamics

Countries

Egypt

Contacts

Primary ContactAbdelrahman Atef Ali, master degree
Abdelrahman_atefuro93@yahoo.com00201000318832
Backup ContactDiaa A Sayed, PhD
diaa_hameed@hotmail.com01203888849

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026