Functional Evaluation of Modified Studer and Modified Spi... | NCT05673044

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

NCT05673044

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 5, 2023Actual

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Orthotopic Neobladders

Interventions

modified Studer ileal neobladder

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 15, 2024Estimated

First Submitted Date

Dec 7, 2022

First Submission Date that Met QC Criteria

Jan 4, 2023

First Posted Date

Jan 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2023

Last Update Posted Date

Jan 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrahman Atef Ali, Assistant lecturer of Urology Assuit University Hospital, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
modified Studer ileal neobladder	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.	Procedure: modified Studer ileal neobladder
modified spiral ileal neobladder	Experimental	the chimney of the spiral neobladder will be an angled one instead of straight.	Procedure: modified Studer ileal neobladder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified Studer ileal neobladder	Procedure	orthotopic ileal neobladders	modified Studer ileal neobladder modified spiral ileal neobladder

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Positive prostatic urethral biopsy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdelrahman Atef Ali, master degree	Contact	00201000318832		Abdelrahman_atefuro93@yahoo.com
Diaa A Sayed, PhD	Contact	01203888849		diaa_hameed@hotmail.com

Overall Officials

Name	Affiliation	Role
Diaa Eldin hameed Sayed, PhD	cheif of urological oncology department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assuit university		Asyut	Assuit	71511	Egypt