Trial reportInternational journal of colorectal disease2025
The novel BioHealx®assisted fistula treatment (BAFT): effective primary fistula healing with continence preservation.
Trial report in International journal of colorectal disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
backgroundThis is the first in human assessment of the BioHealx® assisted fistula treatment (BAFT) procedure for the primary healing rate of non-branching transsphincteric fistula in ano. The BAFT procedure consists of compression apposition closure of the lumen of the fistula tract from the internal opening across the transsphincteric length of the fistula tract with a bioabsorbable implant (BioHealx device) and distal fistulectomy. This medium-term follow-up study assesses the healing and functional outcome at the last follow-up (12-40 months; average 23.4 months) following this procedure.
methodsThe study was a multi-center, prospective, single-arm (non-randomized), non-blinded, clinical study for elective compression closure of non-branching transsphincteric anal fistula of cryptoglandular origin. Participants were recruited from three sites (two hospitals in Budapest, Hungary and one hospital in Szeged, Hungary). The primary outcome was combined fistula and fistulectomy wound healing, and fecal incontinence quality of life scores (FIQL) were a secondary outcome. Fistula healing was assessed independently in cases where the fistulectomy wound had not fully healed.
resultsThirty-two adults, (18-75 years; M- 27 vs F- 5) were included in the study. The 30-day complication rate was 4/32 (12.5%) and was restricted to the fistulectomy wound with no device-related complications. All patients were assessed in person at 12 months, and patients with unhealed fistulectomy wounds were reassessed after 12 months to confirm fistula healing status. The data demonstrated that 27/32 (84.4%) of transsphincteric fistulas were healed with no recurrences. There were 3(9.4%) persistent transsphincteric fistulas and 2 (6.3%) with undocumented fistula healing with healing fistulectomy wound at last follow-up. Assessment of available baseline and last follow-up FIQL scores demonstrated stable or improved scores for 30/31 (96.8%). Surgeon assessment reflected ease of adoption.
conclusionsThis first in human assessment of the BAFT procedure for transsphincteric cryptoglandular fistula in ano demonstrated an 84.4% rate of primary healing without recurrence of transsphincteric fistulas with preservation of fecal continence quality of life in 96.8% of patients. Successful compression apposition closure of the fistula tract lumen within the anal sphincter complex delivered the healing rate by primary intention of the fistula tract without any device-related complications or migration. Surgeon mastery of the procedure is straightforward. These outcome data support both a high rate of initial healing and durability of the BAFT procedure for transsphincteric cryptoglandular fistula in ano that are favorable when compared to LIFT, endoanal flap, cutting seton, or fistulotomy/sphincteroplasty surgical options.
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