Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

Not Applicable

Completed

• Conditions: Chronic Anal Fissure
• Interventions: Procedure: TENS; Procedure: lateral internal sphincterotomy

• Registration Number: NCT02395809
• Lead Sponsor: Mansoura University

Brief 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. 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 Timeline

• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Study First Posted: 2015-03-24
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TENS group	TENS	Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit.
LIS group	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.

Primary Outcome Measures

Name	Time	Method
number of patients with clinical improvement of symptoms	one year	Resolution of anal pain after the procedure

Secondary Outcome Measures

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