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

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What is being tested

modified Studer ileal neobladder

Procedure
Who is being recruted

+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2023
See protocol details

Summary

Principal SponsorAssiut University
Study ContactAbdelrahman Atef Ali, master degreeMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2023

Actual date on which the first participant was enrolled.

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.

Official TitleFunctional Evaluation of Modified Studer and Modified Spiral Orthotopic Ileal Neobladders After Radical Cystectomy.
NCT05673044
Principal SponsorAssiut University
Study ContactAbdelrahman Atef Ali, master degreeMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.

5 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Assuit university

Asyut, EgyptOpen Assuit university in Google Maps
SuspendedOne Study Center