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Study halted due to lower success rates than expected, under evaluation, will potentially resume at a later date.
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The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula
Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser coagulation | Experimental | Treatment of anal fistulae meeting the inclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Coagulation | Procedure | Laser coagulation of anal fistula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing | Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment. | 12 months |
| Incontinence | Presence of fecal incontinence as described by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21845480 | Background | Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16. | |
| 25724967 | Background | Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28. |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D017075 | Laser Coagulation |
| ID | Term |
|---|---|
| D008028 | Light Coagulation |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D053685 | Laser Therapy |
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| 12 months |
| 24119103 | Background | Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440. |
| 24509460 | Background | Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067. |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |
| D013508 | Ophthalmologic Surgical Procedures |