The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY

Rectal Ulcer Clinical Trial

Official title:

The Biofeedback Therapy in Solitery Rectal Ulser Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334995
• Other study ID #: SRUS-BF
• Secondary ID: SRUS-BF
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 24, 2016
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2016
• Source: Ege University
• Contact: Serhat Bor
• Phone: +902323905216
• Email: serhatbor[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Description:

dyssynergia treating ulcers caused by treatment with biofeedback

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Ulcer

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ulcer diameter shrinkage	ulcer diameter measured in rectosigmoidoscopy	6-8 weeks	Yes