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Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

Primary Purpose

Chronic Anal Fissure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lateral internal sphincterotomy
TENS
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Anal Fissure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    LIS group

    TENS group

    Arm Description

    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 When the knife was felt beneath the intact mucosa, it was withdrawn.

    Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit.

    Outcomes

    Primary Outcome Measures

    number of patients with clinical improvement of symptoms
    Resolution of anal pain after the procedure

    Secondary Outcome Measures

    number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence
    Number of patients with improvement of constipation according to Wexner constipation score
    Anal pain scores on VAS
    Post-procedure patient satisfaction on VAS
    Number of patients with healed anal fissure
    Complete epithelialization of the fissure

    Full Information

    First Posted
    March 9, 2015
    Last Updated
    March 17, 2015
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02395809
    Brief Title
    Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure
    Official Title
    Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Anal Fissure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LIS group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    TENS group
    Arm Type
    Active Comparator
    Arm Description
    Posterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit.
    Intervention Type
    Procedure
    Intervention Name(s)
    lateral internal sphincterotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    TENS
    Primary Outcome Measure Information:
    Title
    number of patients with clinical improvement of symptoms
    Description
    Resolution of anal pain after the procedure
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence
    Time Frame
    one year
    Title
    Number of patients with improvement of constipation according to Wexner constipation score
    Time Frame
    one year
    Title
    Anal pain scores on VAS
    Time Frame
    one month
    Title
    Post-procedure patient satisfaction on VAS
    Time Frame
    one year
    Title
    Number of patients with healed anal fissure
    Description
    Complete epithelialization of the fissure
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26316154
    Citation
    Youssef T, Youssef M, Thabet W, Lotfy A, Shaat R, Abd-Elrazek E, Farid M. Randomized clinical trial of transcutaneous electrical posterior tibial nerve stimulation versus lateral internal sphincterotomy for treatment of chronic anal fissure. Int J Surg. 2015 Oct;22:143-8. doi: 10.1016/j.ijsu.2015.08.033. Epub 2015 Aug 24.
    Results Reference
    derived

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    Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure

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