Fissure in Ano
Conditions
Keywords
Anal fissure, Percutaneous Tibial Nerve Stimulation, PTNS
Brief summary
Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.
Detailed description
This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons. The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months. If the patients symptoms are unimproved at 3 months alternative treatments will be offered.
Interventions
DEVICEPTNS
Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.
Sponsors
Region Skane
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective non-randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Verified anal fissure (Clinical assessement by experienced proctological surgeon) * Full conservative treatment has been given
Exclusion criteria
* Inflammatory bowel disease * Fistula and/or anal abscess * Patients with compromised immunity * Pregnancy * Treatment with anti-coagulants (not aspirin) * Previous irradiation towards pelvic floor * Pacemaker or implanted defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing rate | 3 months after treatment | Healing of anal fissure from assessement of clinical and/or data from patient form |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movements | 3 months after treatment | Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment |
| Adverse effects | 3 months after treatment | Reports of adverse effects (subjective/objective) |
| Smoking | 3 months after treatment | Differences in healing rates between smokers and non-smokers |
Countries
Sweden
Contacts
Primary ContactMartin Lindsten, MD
Backup ContactSara Strandberg
Outcome results
None listed