Clinical trial NCT05673044: Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
Official title: Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthotopic Neobladders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The assessment of the reservoir capacity
timeFrame: At 3rd month post operative
measure: The assessment of the reservoir capacity
timeFrame: At 6th month post operative
measure: The assessment of the reservoir capacity
timeFrame: At 12th month post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university
state: Assuit
Study officials:
affiliation: cheif of urological oncology department
name: Diaa Eldin hameed Sayed, PhD
role: STUDY_DIRECTOR
References: