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OpenTrials
Completed

NCT Number: NCT02395809

Transcutaneous Posterior Tibial Nerve Stimulation 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.

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Key information

Conditions

Chronic Anal Fissure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lateral internal sphincterotomy

Procedure

TENS

Procedure

Primary outcomes

  1. number of patients with clinical improvement of symptoms

    Time frame: one year

    Resolution of anal pain after the procedure

Secondary outcomes

  1. number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence

    Time frame: one year

  2. Number of patients with improvement of constipation according to Wexner constipation score

    Time frame: one year

  3. Anal pain scores on VAS

    Time frame: one month

  4. Post-procedure patient satisfaction on VAS

    Time frame: one year

  5. Number of patients with healed anal fissure

    Time frame: one month

    Complete epithelialization of the fissure

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2015
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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