Chronic Anal Fissure
Conditions
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.
Interventions
PROCEDURElateral internal sphincterotomy
PROCEDURETENS
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with clinical improvement of symptoms | one year | Resolution of anal pain after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Complete epithelialization of the fissure |
Outcome results
None listed