Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.

Conditions
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Chronic Anal Fissure

Intervention / Treatment
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* Procedure: lateral internal sphincterotomy
* Procedure: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study. Exclusion Criteria: patients younger than 18 years; patients with laterally located or painless fissures; concurrent fistula or significant hemorrhoidal disease; inflammatory bowel disease; Diabetes mellitus; pregnancy; neurological disease; spinal cord lesions, use of cardiac pacemaker. Males and females were considered for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LIS group<br>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. | Procedure: lateral internal sphincterotomy<br> <br> |
| Active Comparator: TENS group<br>Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit. | Procedure: TENS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with clinical improvement of symptoms | Resolution of anal pain after the procedure | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence |  | one year | 
| Number of patients with improvement of constipation according to Wexner constipation score |  | one year | 
| Anal pain scores on VAS |  | one month | 
| Post-procedure patient satisfaction on VAS |  | one year | 
| Number of patients with healed anal fissure | Complete epithelialization of the fissure | one month |