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
About this trial
This is an interventional treatment trial for Chronic Anal Fissure
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.
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 When the knife was felt beneath the intact mucosa, it was withdrawn.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
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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