Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

NCT ID: NCT02395809

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-07-31

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.

Conditions

Chronic Anal Fissure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LIS group

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 When the knife was felt beneath the intact mucosa, it was withdrawn.

Group Type: ACTIVE_COMPARATOR

lateral internal sphincterotomy

Intervention Type: PROCEDURE

TENS group

Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit.

Group Type: ACTIVE_COMPARATOR

TENS

Intervention Type: PROCEDURE

Interventions

lateral internal sphincterotomy

Intervention Type: PROCEDURE

TENS

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Tamer Youssef Mohamed

Tamer Youssef

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 26316154 (View on PubMed)

Other Identifiers

MFM201215

Identifier Type: -

Identifier Source: org_study_id