Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure
Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
1 other identifier
interventional
94
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedMarch 24, 2015
March 1, 2015
1 year
March 9, 2015
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
number of patients with clinical improvement of symptoms
Resolution of anal pain after the procedure
one year
Secondary Outcomes (5)
number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence
one year
Number of patients with improvement of constipation according to Wexner constipation score
one year
Anal pain scores on VAS
one month
Post-procedure patient satisfaction on VAS
one year
Number of patients with healed anal fissure
one month
Study Arms (2)
LIS group
ACTIVE COMPARATORLateral 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 When the knife was felt beneath the intact mucosa, it was withdrawn.
TENS group
ACTIVE COMPARATORPosterior tibial nerve stimulation by transcutaneous electrical nerve stimulation by through a stimulating TENS unit.
Interventions
Eligibility Criteria
You may qualify if:
- Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26316154DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tamer Youssef
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 24, 2015
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 24, 2015
Record last verified: 2015-03