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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05673044
Collaborator
(none)
52
1
2
23.5
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: modified Studer ileal neobladder
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Functional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: modified Studer ileal neobladder
orthotopic ileal neobladders
Other Names:
  • modified spiral ileal neobladder
  • Experimental: modified spiral ileal neobladder

    the chimney of the spiral neobladder will be an angled one instead of straight.

    Procedure: modified Studer ileal neobladder
    orthotopic ileal neobladders
    Other Names:
  • modified spiral ileal neobladder
  • Outcome Measures

    Primary Outcome Measures

    1. The assessment of the reservoir capacity [At 3rd month post operative]

      Assessment of reservoir capacity by pouch size in urodynamics

    2. The assessment of the reservoir capacity [At 6th month post operative]

      Assessment of reservoir capacity by pouch size in urodynamics

    3. The assessment of the reservoir capacity [At 12th month post operative]

      Assessment of reservoir capacity by pouch size in urodynamics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuit university Assiut Assuit Egypt 71511

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Diaa Eldin hameed Sayed, PhD, cheif of urological oncology department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdelrahman Atef Ali, Assistant lecturer of Urology Assuit University Hospital, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05673044
    Other Study ID Numbers:
    • Assuituro
    First Posted:
    Jan 5, 2023
    Last Update Posted:
    Jan 5, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 5, 2023