"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"
- Conditions
- Anal Fistula
- Registration Number
- NCT04740086
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Signed Informed Consent Form
- Age ≥18 years
- Cryptoglandular PAF treated by Seton placement for at least 3 months, with a single External Fistulous Orifice and Internal Fistulous Orifice
- Informed Consent Form not signed or withdrawn
- Not possible to adhere to follow-up routine
- Another investigational drug in the previous 3 months
- Allergy to alginate
- Grade IV in American Society of Anesthesiologists scale
- Pregnancy
- History of radiotherapy in the perineal area
- Diagnosis or suspicion of Intestinal Blow Disease
- Immunosuppression, active neoplasia at the time of recruitment or in previous year, or positive for human immunodeficiency virus Internal Fistulous Orifice not located during the procedure
- Simple anal fistula (submucosa or low Intersphincteric Perianal Fistula, except association with Faecal Incontinence
- Anal stenosis that prevents exploration
- Undrained collections >2 cm
- Rectovaginal fistulas
- Fistulas of non-cryptoglandular origin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events at 6 months At 6 months Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of adverse events at 12 months At 12 months Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of adverse events at 1 month At 1 month Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of adverse events at 3 months At 3 months Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of patients treated following the protocol during the surgery 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.
- Secondary Outcome Measures
Name Time Method Ecographic curation at 12 months 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.
Clinical curation at 6 months 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
Clinical curation at 1 month 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
Clinical curation at 3 months 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
Clinical curation at 12 months 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
Trial Locations
- Locations (1)
Sandra Dios Barbeito
🇪🇸Seville, Spain