Clinical Trial: Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Mansoura University

Current Primary Outcome: number of patients with clinical improvement of symptoms [ Time Frame: one year ]

Resolution of anal pain after the procedure


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: March 9, 2015
Date Started: July 2012
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015