The Biofeedback Therapy in Solitery Rectal Ulser Patients... | NCT02334995

Studies
The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY

NCT02334995

Sponsor

Ege University

Status

Unknown status

Last Update Posted

Jan 26, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Rectal Ulcer

Interventions

Not provided

Countries

Turkey (Türkiye)

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

ID	Type	Description	Link
SRUS-BF	Registry Identifier	SRUS-BF

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jan 7, 2015

First Submission Date that Met QC Criteria

Jan 7, 2015

First Posted Date

Jan 9, 2015Estimated

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 24, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer.

Detailed Description

dyssynergia treating ulcers caused by treatment with biofeedback

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

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ulcer diameter shrinkage	ulcer diameter measured in rectosigmoidoscopy	6-8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

solitary rectal ulcer in rectosigmoidoscopy
type 1 or 3 dissynergic defecation
to accept to participate to study and sign informed consent

Exclusion Criteria:

previously applied biofeedback
serious psychiatric disorder
previous anorectal surgery
the presence of active malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with solitary rectal ulser

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Serhat Bor	Contact	+902323905216		serhatbor@yahoo.com

Overall Officials

Name	Affiliation	Role
Serhat Bor		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University Faculty of Medicine	Recruiting	Izmir			Turkey (Türkiye)