NCT02334995

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

January 7, 2015

Last Update Submit

January 24, 2016

Conditions

Rectal Ulcer

Keywords

solitery rectal ulcerbiofeedbackdissynergy

Outcome Measures

Primary Outcomes (1)

  • ulcer diameter shrinkage

    ulcer diameter measured in rectosigmoidoscopy

    6-8 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with solitary rectal ulser

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Medicine

Izmir, Turkey (Türkiye)

RECRUITING

Study Officials

  • Serhat Bor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serhat Bor

CONTACT

+902323905216serhatbor@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

TU(1)