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Clinical Trial Summary

Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.


Clinical Trial Description

This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons. The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months. If the patients symptoms are unimproved at 3 months alternative treatments will be offered. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04604483
Study type Interventional
Source Region Skane
Contact Martin Lindsten, MD
Phone +4640331000
Email martin.lindsten@skane.se
Status Not yet recruiting
Phase N/A
Start date October 1, 2024
Completion date December 2026

See also
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Completed NCT05837403 - The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure Phase 3
Recruiting NCT02419534 - Pediatrics Anal Fissures Treatment With Polyethylene Glycol Phase 4
Recruiting NCT05590520 - Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure N/A
Withdrawn NCT03105674 - Multi-Drug Analgesia vs. Standard Solution for Anal Surgery Phase 4
Completed NCT05993793 - Use of Fototherapy in the Treatment of Fissure in Ano N/A
Not yet recruiting NCT04887818 - Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure Phase 2/Phase 3
Completed NCT02402543 - Pre-Emptive Analgesia in Ano-Rectal Surgery N/A
Completed NCT05091775 - The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure Phase 1/Phase 2
Unknown status NCT00328900 - Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine N/A
Not yet recruiting NCT04714684 - The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure N/A
Completed NCT03405922 - Perianal Nerval Block in Proctological Interventions Phase 4
Completed NCT00522041 - A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures Phase 3