Rectal UlcerNCT02334995
The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY
An observational study of Rectal Ulcer, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Ulcer
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solitary rectal ulser
Who may be able to join
- solitary rectal ulcer in rectosigmoidoscopy
- type 1 or 3 dissynergic defecation
- to accept to participate to study and sign informed consent
Who cannot join
- previously applied biofeedback
- serious psychiatric disorder
- previous anorectal surgery
- the presence of active malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Faculty of Medicine
Izmir
Serhat Bor
About this study
Official title: The Biofeedback Therapy in Solitery Rectal Ulser Patients
Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer.
Read the detailed description
dyssynergia treating ulcers caused by treatment with biofeedback
- Conditions
- Rectal Ulcer
- Keywords
- solitery rectal ulcer, biofeedback, dissynergy
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer diameter shrinkage
ulcer diameter measured in rectosigmoidoscopy
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal UlcerStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serhat Bor, Ege University
- Investigators
- Serhat Bor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334995
- Sponsor's protocol ID
- SRUS-BF
- Other IDs
- SRUS-BF
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biofeedback Therapy in Solitery Rectal Ulser Patients
- ClinicalTrials.gov ID
- NCT02334995
- Acronym / sponsor ID
- SRUS-BF
- Conditions
- Rectal Ulcer
- Keywords
- solitery rectal ulcer, biofeedback, dissynergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solitary rectal ulser
Key inclusion criteria (3 listed)
- solitary rectal ulcer in rectosigmoidoscopy
- type 1 or 3 dissynergic defecation
- to accept to participate to study and sign informed consent
Key exclusion criteria (4 listed)
- previously applied biofeedback
- serious psychiatric disorder
- previous anorectal surgery
- the presence of active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ulcer diameter shrinkage
Time frame: 6-8 weeks
ulcer diameter measured in rectosigmoidoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serhat Bor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Ulcer, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serhat Bor (+902323905216, serhatbor@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ulcer diameter shrinkage (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.