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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthotopic Neobladders
• Intervention / Treatment: Procedure: modified Studer ileal neobladder

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrahman Atef Ali, master degree; Phone Number: 00201000318832; Email: Abdelrahman_atefuro93@yahoo.com
• Study Contact Backup: Name: Diaa A Sayed, PhD; Phone Number: 01203888849; Email: diaa_hameed@hotmail.com

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, 71511
      • Assuit university
      • Contact: Abdelrahman Atef Ali, M.D; Phone Number: 01000318832; Email: kartel_king007@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The assessment of the reservoir capacity	Assessment of reservoir capacity by pouch size in urodynamics	At 3rd month post operative
The assessment of the reservoir capacity	Assessment of reservoir capacity by pouch size in urodynamics	At 6th month post operative
The assessment of the reservoir capacity	Assessment of reservoir capacity by pouch size in urodynamics	At 12th month post operative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Diaa Eldin hameed Sayed, PhD, cheif of urological oncology department

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 15, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Assuituro

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No