Bakircay University Cigli Training and Research Hospital | NCT04683536

Studies
Bakircay University Cigli Training and Research Hospital

NCT04683536

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Last Update Posted

Dec 24, 2020Actual

Enrollment

106Actual

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Obturator nerve blockade

Countries

Not provided

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 2020Actual

First Submitted Date

Dec 19, 2020

First Submission Date that Met QC Criteria

Dec 19, 2020

First Posted Date

Dec 24, 2020Actual

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

Dec 19, 2020

Last Update Posted Date

Dec 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Ozan HORSANALI, Bakircay University Cigli Training and Research Hospital, Recep Tayyip Erdogan University Training and Research HospitalPrincipal Investigator

Lead Sponsor

Recep Tayyip Erdogan University Training and Research HospitalOTHER

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

The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer

Detailed Description

Patient divided into two group.First group includes patients underwent TUR-BT under only spinal anesthesia and second group includes patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		Patients underwent TUR-BT under spinal anesthesia	Procedure: Obturator nerve blockade
Study group		Patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade	Procedure: Obturator nerve blockade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obturator nerve blockade	Procedure	We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oncological outcomes	Reccurens or progression of tumor was recorded	5 year

Secondary Outcomes

Measure	Description	Time Frame
Complications	Complications during surgery was recorded	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with lateral wall localized non muscle invasive bladder cancer

Exclusion Criteria:

history of previous TUR-BT
diagnosis of non-urothelial carcinoma
coagulopathy
history of allergic reaction to the local anesthtetic agent
presence of muscle-invasive bladder cancer
history of chemotherapy or radiotherapy before TUR-BT
precence of variant histopathology
using bipolar energy for the resection of bladder tumor
presence of concomittant upper urothelial tract urothelial carcinoma
patients with the neuromusculer disease
pregnancy
history of medication effecting immune system

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

Patients diagnosed with lateral wall localized non muscle invasive bladder cancer underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms
D000093284	Non-Muscle Invasive Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided