Chronic Anal FissureNCT02395809
Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure
A study testing lateral internal sphincterotomy and TENS in people with Chronic Anal Fissure, run by Mansoura University.
Trial summary
Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are compared with a healing rate over 92%. However, the most serious complication of this procedure is anal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- lateral internal sphincterotomy and TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jul 2013
- Phase
- Interventional
- 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
Who may be able to join
- Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study.
Who cannot join
- patients younger than 18 years;
- patients with laterally located or painless fissures;
- concurrent fistula or significant hemorrhoidal disease;
- inflammatory bowel disease;
- Diabetes mellitus;
- pregnancy;
Show all 9Show fewer
- neurological disease;
- spinal cord lesions,
- use of cardiac pacemaker. Males and females were considered for inclusion.
About this study
Official title: Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are compared with a healing rate over 92%. However, the most serious complication of this procedure is anal incontinence. To overcome these problems, continued efforts are being tried to find less invasive treatments modalities for anal fissure that is as effective as surgical therapy with lower morbidity.
Read the detailed description
Sacral nerve stimulation has been recently tried for management of chronic anal fissure with promising results. However, the technique described is invasive with the need for surgically implantable expensive stimulator electrodes.
The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTN) by transcutaneous electrical nerve stimulation (TENS) and to compare it to the conventional LIS. This non-invasive technique has been proved to be of acceptable results in treatment of fecal incontinence and urinary incontinence.
- Conditions
- Chronic Anal Fissure
- Being tested
- lateral internal sphincterotomy, TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral internal sphincterotomyProcedure or surgery
TENSProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LIS group | Active comparator | Lateral internal shincterotomy: A blade knife (No 11) was inserted between internal and external sphincter. The tip of the blade was angled medially pointing just above the dentate line and IS was divided. When the knife was felt beneath the intact mucosa, it was withdrawn. Receives: Procedure: lateral internal sphincterotomy |
| TENS group | Active comparator | Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit. Receives: Procedure: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with clinical improvement of symptoms
Resolution of anal pain after the procedure
Measured: one year
Secondary outcomes (5)
number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence
Measured: one year
Number of patients with improvement of constipation according to Wexner constipation score
Measured: one year
Anal pain scores on VAS
Measured: one month
Post-procedure patient satisfaction on VAS
Measured: one year
Number of patients with healed anal fissure
Complete epithelialization of the fissure
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Anal FissureStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Youssef Mohamed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395809
- Sponsor's protocol ID
- MFM201215
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Youssef T, Youssef M, Thabet W, Lotfy A, Shaat R, Abd-Elrazek E, Farid M. Randomized clinical trial of transcutaneous electrical posterior tibial nerve stimulation versus lateral internal sphincterotomy for treatment of chronic anal fissure. Int J Surg. 2015 Oct;22:143-8. doi: 10.1016/j.ijsu.2015.08.033. Epub 2015 Aug 24.
PubMed 26316154
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
- ClinicalTrials.gov ID
- NCT02395809
- Acronym / sponsor ID
- MFM201215
- Conditions
- Chronic Anal Fissure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Mar 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.
Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are compared with a healing rate over 92%. However, the most serious complication of this procedure is anal incontinence. To overcome these problems, continued efforts are being tried to find less invasive treatments modalities for anal fissure that is as effective as surgical therapy with lower morbidity.
Detailed description
Sacral nerve stimulation has been recently tried for management of chronic anal fissure with promising results. However, the technique described is invasive with the need for surgically implantable expensive stimulator electrodes.
The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTN) by transcutaneous electrical nerve stimulation (TENS) and to compare it to the conventional LIS. This non-invasive technique has been proved to be of acceptable results in treatment of fecal incontinence and urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIS group | Active comparator | Procedure: lateral internal sphincterotomyLateral internal shincterotomy: A blade knife (No 11) was inserted between internal and external sphincter. The tip of the blade was angled medially pointing just above the dentate line and IS was divided. When the knife was felt beneath the intact mucosa, it was withdrawn. |
| TENS group | Active comparator | Procedure: TENSPosterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study.
Key exclusion criteria (9 listed)
- patients younger than 18 years;
- patients with laterally located or painless fissures;
- concurrent fistula or significant hemorrhoidal disease;
- inflammatory bowel disease;
- Diabetes mellitus;
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 internal sphincterotomy | Procedure or surgery | LIS group |
| TENS | Procedure or surgery | TENS group |
Primary outcome
number of patients with clinical improvement of symptoms
Time frame: one year
Resolution of anal pain after the procedure
5 secondary outcomes
number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence
Time frame: one year
Number of patients with improvement of constipation according to Wexner constipation score
Time frame: one year
Anal pain scores on VAS
Time frame: one month
Post-procedure patient satisfaction on VAS
Time frame: one year
Number of patients with healed anal fissure
Time frame: one month
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 24 Mar 2015.
- Derived from this study: PubMed 26316154Youssef T, Youssef M, Thabet W, Lotfy A, Shaat R, Abd-Elrazek E, Farid M. Randomized clinical trial of transcutaneous electrical posterior tibial nerve stimulation versus lateral internal sphincterotomy for treatment of chronic anal fissure. Int J Surg. 2015 Oct;22:143-8. doi: 10.1016/j.ijsu.2015.08.033. Epub 2015 Aug 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing lateral internal sphincterotomy and TENS in people with Chronic Anal Fissure, run by Mansoura University.
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 9 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
number of patients with clinical improvement of symptoms (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395809, which also lists 1 linked publication.
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 24 Mar 2015.