An observational study in Anal Fistula, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
Background: Complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence. Biological sealants have emerged as an effective alternative for maintaining the integrity of the anal sphincter. The investigators aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the tract as treatment for complex cryptoglandular fistulas.
Methods: A prospective, single-center, case series of this novel technique was conducted in a level 3 hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6, and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment.
189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.
This study's enrollment of 20 is below the median of 94 across 50 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
20 patients with a single complex cryptoglandular perianal fistula
Exclusion Criteria:
1. The external and internal fistulous orifice and fistulous tract were explored without applying any product, including hydrogen peroxide or povidone-iodine. 2. The seton was removed and FT cannulation was performed using a needle for cleaning with a gauze impregnated with saline. 3. Calcium chloride was applied through the EFO until it exits through the IFO, and then the IFO was obturated. 4. Alginate was applied, and the pressure at the IFO was stopped, until the alginate solution partial exits through the IFO. 5. The IFO was closed with a 3/0 braided resorbable suture. 6. The EFO was removed with an electric scalpel and closed with a 3/0 braided resorbable suture.
Incidence of patients treated following the protocol during the surgery
Feasibility is measured as the ratio between the number of patients who received the injection following all the steps of the protocol and the total number of individuals included in the study.
Time frame: During the surgery
Incidence of adverse events at 1 month
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Time frame: At 1 month
Incidence of adverse events at 3 months
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Time frame: At 3 months
Incidence of adverse events at 6 months
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Time frame: At 6 months
Incidence of adverse events at 12 months
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Time frame: At 12 months
Ecographic curation at 12 months
Closure of the external fistulous orifice that prevented the injection of hydrogen peroxide diluted to 50 percent, in addition to the absence of hyperechogenic collections and images suggesting the existence of pus or air in the tract.
Time frame: At 12 months
Clinical curation at 1 month
Complete cure defined as the absence of suppuration and scarring in the external fistulous orifice; partial cure defined as the absence of suppuration and scarring in the external fistulous orifice without complete re-epithelialization; treatment failure or lack of cure defined as suppuration and/or scarring in the external fistulous orifice
Time frame: At 1 month
Clinical curation at 3 months
Complete cure defined as the absence of suppuration and scarring in the external fistulous orifice; partial cure defined as the absence of suppuration and scarring in the external fistulous orifice without complete re-epithelialization; treatment failure or lack of cure defined as suppuration and/or scarring in the external fistulous orifice
Time frame: At 3 months
Clinical curation at 6 months
Complete cure defined as the absence of suppuration and scarring in the external fistulous orifice; partial cure defined as the absence of suppuration and scarring in the external fistulous orifice without complete re-epithelialization; treatment failure or lack of cure defined as suppuration and/or scarring in the external fistulous orifice
Time frame: At 6 months
Clinical curation at 12 months
Complete cure defined as the absence of suppuration and scarring in the external fistulous orifice; partial cure defined as the absence of suppuration and scarring in the external fistulous orifice without complete re-epithelialization; treatment failure or lack of cure defined as suppuration and/or scarring in the external fistulous orifice
Time frame: At 12 months
Plan to share: No
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla