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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02395809
Other study ID # MFM201215
Secondary ID
Status Completed
Phase N/A
First received March 9, 2015
Last updated March 17, 2015
Start date July 2012
Est. completion date July 2013

Study information

Verified date March 2015
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Mansoura Faculty of medicine
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
lateral internal sphincterotomy

TENS


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients with clinical improvement of symptoms Resolution of anal pain after the procedure one year Yes
Secondary number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence one year Yes
Secondary Number of patients with improvement of constipation according to Wexner constipation score one year Yes
Secondary Anal pain scores on VAS one month Yes
Secondary Post-procedure patient satisfaction on VAS one year Yes
Secondary Number of patients with healed anal fissure Complete epithelialization of the fissure one month Yes
See also
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Completed NCT01217515 - Diltiazem Hydrochloride Cream for Anal Fissure Phase 3
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Completed NCT02527109 - The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure Phase 2/Phase 3
Recruiting NCT03920449 - Postero-lateral Internal Sphincterotomy vs Botulinum Toxin Injection in the Treatment of Chronic Anal Fissure N/A
Enrolling by invitation NCT04793347 - Effect of Shock Waves Therapy on Chronic Anal Fissure N/A
Completed NCT04166175 - High Dose Multiple Site Injection of Botox Versus Lateral Sphincterotomy in Chronic Analfissure N/A
Completed NCT01500889 - Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty and Tailored Lateral Internal Sphincterotomy With V-YF in Treatment of Chronic Anal Fissure(CAF) N/A
Completed NCT01132391 - Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure Phase 3
Completed NCT03872765 - Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure N/A
Completed NCT00972907 - An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects Phase 1/Phase 2