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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTNS | Experimental | Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS | Device | Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate | Healing of anal fissure from assessement of clinical and/or data from patient form | 3 months after treatment |
| Healing rate | Healing of anal fissure from assessement of clinical and/or data from patient form | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movements | Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment | 3 months after treatment |
| Bowel movements | Changes in frequency of bowel emptying and consistency of bowel contents Before and after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Lindsten, MD | Contact | +4640331000 | martin.lindsten@skane.se | |
| Sara Strandberg | Contact | +4640331000 | sara.strandberg@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Louis B Johnson, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22336789 | Background | Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3. |
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No intention to make individual participant data available to other researchers
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Prospective non-randomized trial
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| 12 months after treatment |
| Adverse effects | Reports of adverse effects (subjective/objective) | 3 months after treatment |
| Adverse effects | Reports of adverse effects (subjective/objective) | 12 months after treatment |
| Smoking | Differences in healing rates between smokers and non-smokers | 3 months after treatment |
| Smoking | Differences in healing rates between smokers and non-smokers | 12 months after treatment |
| D004066 |
| Digestive System Diseases |