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The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its treatment remains a real challenge due to the limited efficacy of sphincter preservation techniques and the inevitable risk of faecal incontinence in those cases that require surgery. Goals: To evaluate the efficacy and safety of the injection of freshly collected autologous adipose tissue as a minimally invasive, highly reproducible alternative, without risk for the continence of the patient, and of very low cost, in the treatment of complex cryptoglandular anal fistula. Methodology: Prospective multicenter, randomized, double-blinded, parallel-group, placebo-controlled clinical trial. Randomization list for each center to ensure the balance of inter-center allocation. Patients older than 18 years with cryptoglandular anal fistula with suppuration for more than 6 weeks and less than 1 year, who have received at most: curettage and drainage placement will be included. Treatment group: injection of fresh autologous fat into the fistulous tract, after curettage and closure of the internal orifice, and after lipoaspirate fat in the abdomen and centrifugation thereof. Placebo group: curettage and closure of the internal orifice and simulated intervention in the abdomen. Evaluation: protocolized clinical history and fistula complexity score (CFS), subjective perception of its pathology, St.Marks continence score, Quality of life questionnaire (QoLAF), and endoanal 3D ultrasound, at baseline, at one week, and at 3, 6 and 12 months after the intervention. The patients and the evaluator will be blind to the treatment. Patients who cannot end up receiving treatment due to intraoperative incidents or medical decision will be excluded from the study (post randomization exclusion). In each center there will be a blind evaluator to perform the follow-ups and endoanal ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator |
| |
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of autologous freshly collected adipose tissue | Procedure | injection of fresh autologous fat, previously lipoaspirates from the patient's abdomen and centrifugated, into the fistulous tract, after curettage and closure of the internal opening. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete fistula healing | Comparison of the proportion of cases with complete fistula healing within 24 weeks of the intervention, defined as the absence of drainage through the external orifice, its complete reepithelialization and the absence of collections confirmed by endoanal ultrasound. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Quality of life | Improvement in quality of life (measured with the Quality of Life in Patients with Anal Fistula Questionnaire, QoLAF). Score from 14 to 70, where 14 means "no quality of life alteration" and 70 means "severe quality of life alteration". | 6 and 12 months after treatment. |
| Patient's Subjective Perception |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Mutua Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
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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 |
|---|---|
| C005703 | salicylhydroxamic acid |
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| sham | Procedure | curettage and closure of the internal orifice of the anal fistula and simulated intervention in the abdomen. |
|
Improvement in patient subjective evaluation using a Visual Analogue Scale (VAS). Score from 0 to 10, where 0 means "no problem" and 10 means "severe problem and alteration of my quality of life". |
| 6 and 12 months after treatment. |
| Fistula severity | Improvement in fistula severity according to the Complexity Fistula score (CFS). Score from 3 to 15, where 3 means "low complexity" and 15 means "high complexity" | 6 and 12 months after treatment. |
| Adverse events | Evaluation of the safety by the incidence of adverse events and serious adverse events. | 3, 6 and 12 months after treatment. |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |