Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

March 17, 2015 updated by: Tamer Youssef Mohamed, Mansoura University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with clinical improvement of symptoms
Time Frame: one year
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
Time Frame: one year
one year
Number of patients with improvement of constipation according to Wexner constipation score
Time Frame: one year
one year
Anal pain scores on VAS
Time Frame: one month
one month
Post-procedure patient satisfaction on VAS
Time Frame: one year
one year
Number of patients with healed anal fissure
Time Frame: one month
Complete epithelialization of the fissure
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFM201215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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