PainNCT01095900
Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure
An observational study of Pain, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain
- What is being tested?
- conservative lateral internal sphincterotomy and Intra-sphincteric Botulinum-toxin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Start not givento not given
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: This trial included consecutive adult patients presenting with symptomatic chronic anal fissure in which conservative treatment had failed.
Who may be able to join
- The diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor.
Who cannot join
- Anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of General Surgery-Theodore Bilharz Research Institute ,
Cairo
About this study
Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.
Read the detailed description
consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.
- Conditions
- Pain
- Being tested
- conservative lateral internal sphincterotomy, Intra-sphincteric Botulinum-toxin injection
- Keywords
- Pain after treatment, healing of fissure after treatment, continence scores after treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative lateral internal sphincterotomyProcedure or surgery
Intra-sphincteric Botulinum-toxin injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LIS group) | Not described Receives: Procedure: conservative lateral internal sphincterotomy | |
| BT group | Not described Receives: Procedure: Intra-sphincteric Botulinum-toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain relief, healing of fissure, continence scores
Measured: 18 weeks
Secondary outcomes (1)
fissure relapse
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095900
- Sponsor's protocol ID
- TheodorBRI
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure
- ClinicalTrials.gov ID
- NCT01095900
- Acronym / sponsor ID
- TheodorBRI
- Conditions
- Pain
- Keywords
- Pain after treatment, healing of fissure after treatment, continence scores after treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- First posted
- 30 Mar 2010 (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.
Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.
Detailed description
consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIS group) | – | Procedure: conservative lateral internal sphincterotomy |
| BT group | – | Procedure: Intra-sphincteric Botulinum-toxin injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This trial included consecutive adult patients presenting with symptomatic chronic anal fissure in which conservative treatment had failed.
Key inclusion criteria (1 listed)
- The diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor.
Key exclusion criteria (1 listed)
- Anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.
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 |
|---|---|---|
| conservative lateral internal sphincterotomy | Procedure or surgery | LIS group) |
| Intra-sphincteric Botulinum-toxin injection | Procedure or surgery | BT group |
Primary outcome
Postoperative pain relief, healing of fissure, continence scores
Time frame: 18 weeks
1 secondary outcome
fissure relapse
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, run by Theodor Bilharz Research Institute at 1 site in Egypt.
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: finished, as of the sponsor's last update on 30 Mar 2010. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain relief, healing of fissure, continence scores (time frame: 18 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 30 Mar 2010.