Preoperative Subclinical DVT Screening in Locally Advance... | NCT04502498

Studies
Preoperative Subclinical DVT Screening in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy.

NCT04502498

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Aug 10, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Bladder Cancer Patients Candidate for Radical Cystectomy

Interventions

Lower limb duplex & doppler

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

Aug 2020

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

Oct 1, 2020Estimated

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Oct 1, 2021Estimated

First Submitted Date

Aug 4, 2020

First Submission Date that Met QC Criteria

Aug 4, 2020

First Posted Date

Aug 6, 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

Aug 6, 2020

Last Update Posted Date

Aug 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate for radical cystectomy.

Detailed Description

60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex within 1 week preoperative to radical cystectomy

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
60 patients with local advanced bladder cancer		Local advanced bladder cancer patients candidate for radical cystectomy	Diagnostic Test: Lower limb duplex & doppler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lower limb duplex & doppler	Diagnostic Test	Lower limb duplex and doppler one week before radical cystectomy	60 patients with local advanced bladder cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preoperative subclinical DVT	Asymptomatic patients candidate for radical cystectomy	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any age
Any sex
Muscle invasive bladder cancer local advanced patients candidate for radical cystectomy

Exclusion Criteria:

Unfit patients
any contraindication for surgery
obese
coagulopathy
bedridden

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

Locally advanced Bladder cancer patients candidate for radical cystectomy and with no symptoms of DVT

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D015150	Echocardiography, Doppler

Ancestor Terms

ID	Term
D004452	Echocardiography
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided