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Glyceryl Trinitrate Ointment vs Posterior Tibial Nerve Stimulation in the Treatment of Anal Fissure

NCT02700438 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-03-07

No results posted yet for this study

Summary

A prospective randomized study was performed. Compliance with the treatment and healing rate of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and subjects undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .

Conditions

Interventions

DRUG

Glyceryl trinitrate ointment

Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.

PROCEDURE

Urgent PC Neuromodulation System®

Subjects underwent one 30-min session of percutaneous posterior tibial nerve stimulation 2 days per week for 8 consecutive weeks in an outpatient clinic, with a Urgent PC Neuromodulation System®. Patients were placed in the supine position without anesthesia. PPTNS was delivered using a needle electrode that was inserted 3-4cm cephalad and 2 cm posterior to the medial malleolus at a 60º angle towards the ankle joint to a depth of approximately 0.5-1cm. Successful placement was confirmed by the presence of electric sensation 5 cm above and below the insertion site or a digital plantar flexion.

Sponsors & Collaborators

  • Hospital General Universitario Elche

    lead OTHER

Principal Investigators

  • Eduardo Barna, MD, PhD · Garcilaso Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700438 on ClinicalTrials.gov