Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
| Registry | NCT02395809 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: single, treatment |
| Enrollment | 94 (Actual) |
| Sponsor | Mansoura University (Other) |
| Conditions | Chronic Anal Fissure |
| Interventions | lateral internal sphincterotomy, TENS (Procedure) |
| Dates | start 2012-07-01, primary completion 2013-07-01, completion 2013-07-01, first posted 2015-03-24, last updated 2015-03-24 |
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All trials for Chronic Anal Fissure All trials of lateral internal sphincterotomy All trials of TENS
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LIS group | Active comparator | Procedure: lateral internal sphincterotomy | 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 When the knife was felt beneath the intact mucosa, it was withdrawn. |
| TENS group | Active comparator | Procedure: TENS | Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study. Exclusion Criteria: 1. patients younger than 18 years; 2. patients with laterally located or painless fissures; 3. concurrent fistula or significant hemorrhoidal disease; 4. inflammatory bowel disease; 5. Diabetes mellitus; 6. pregnancy; 7. neurological disease; 8. spinal cord lesions, 9. use of cardiac pacemaker. Males and females were considered for inclusion.