Comparative Analysis of Outcome Between Extravesical and... | NCT04676568

Studies
Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula

NCT04676568

Sponsor

Armed Forces Institute of Urology, Rawalpindi

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Vesico Vaginal Fistula

Interventions

Extravesical VVF repair

Countries

Pakistan

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

Jul 1, 2019Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Dec 16, 2020

First Submission Date that Met QC Criteria

Dec 16, 2020

First Posted Date

Dec 21, 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 16, 2020

Last Update Posted Date

Dec 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adnan Ali, Consultant Surgeon, Armed Forces Institute of Urology, RawalpindiPrincipal Investigator

Lead Sponsor

Armed Forces Institute of Urology, RawalpindiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
extravesical VVF repair	Active Comparator		Procedure: Extravesical VVF repair
Transvesical VVF repair	Active Comparator		Procedure: Extravesical VVF repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extravesical VVF repair	Procedure	Both standard transvesical and extravesical approach for VVF repair will be utilised	Transvesical VVF repair extravesical VVF repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
operative time	total time taken for surgery	3 months
complications	bladder spasms, bleeding	3 months
recurrence	patients who have recurrenec of symptoms	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with Vesicovaginal fistula

Exclusion Criteria:

uretrovaginal fistula

Accepts Healthy Volunteers

Sex

Female

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Armed Forces Institute of Urology		Rawalpindi	Punjab Province	46000	Pakistan

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
D014719	Vesicovaginal Fistula

Ancestor Terms

ID	Term
D014624	Vaginal Fistula
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided