Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal FissureNCT02020915
Ultrasound Guided Lateral Sphincterotomy: Long Term Results
An observational study of Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure
- What is being tested?
- lateral sphincterotomy and ultrasound guided lateral sphincterotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lateral sphincterotomy for chronic anal fissure
Who may be able to join
- Patients undergoing lateral sphincterotomy for chronic anal fissure
Who cannot join
- Previous diltiazem treatment og botox injections were not performed
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, DK-2650
Michael Sørensen, MD, +4538625457, michael.soerensen.02@regionh.dk
Michael Sørensen, MD
About this study
Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided.
- Being tested
- lateral sphincterotomy, ultrasound guided lateral sphincterotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral sphincterotomyProcedure or surgery
ultrasound guided lateral sphincterotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic anal fissure | Patients are included who had previous treatment with diltiazem or glycerol-nitrate and botox injections Receives: Procedure: lateral sphincterotomy; Procedure: ultrasound guided lateral sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal incontinence
Measured: 5 years or more
Secondary outcomes (1)
Healing of fissure
Measured: 5 years or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startOct 2007
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal FissureStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sørensen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020915
- Sponsor's protocol ID
- Sphincterotomy MSOE
- Status last verified
- Mar 2015
- First submitted
- 19 Dec 2013
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Lateral Sphincterotomy: Long Term Results
- ClinicalTrials.gov ID
- NCT02020915
- Acronym / sponsor ID
- Sphincterotomy MSOE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 25 Dec 2013 (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.
Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic anal fissure | – | Procedure: lateral sphincterotomy, Procedure: ultrasound guided lateral sphincterotomyPatients are included who had previous treatment with diltiazem or glycerol-nitrate and botox injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lateral sphincterotomy for chronic anal fissure
Key inclusion criteria (1 listed)
- Patients undergoing lateral sphincterotomy for chronic anal fissure
Key exclusion criteria (1 listed)
- Previous diltiazem treatment og botox injections were not performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral sphincterotomy | Procedure or surgery | Patients with chronic anal fissure |
| ultrasound guided lateral sphincterotomy | Procedure or surgery | Patients with chronic anal fissure |
Primary outcome
Anal incontinence
Time frame: 5 years or more
1 secondary outcome
Healing of fissure
Time frame: 5 years or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
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.
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 Focus: Anal Incontinence After Lateral Sphincterotomy for Chronic Anal Fissure, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 20 Mar 2015. 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 Denmark. 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 Michael Sørensen, MD (+4538625457, michael.soerensen.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anal incontinence (time frame: 5 years or more). 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 20 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.