Clinical trial NCT04740086: "Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"
Official title: "Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Fistula
Keywords: cryptoglandular anal fistula
calcium alginate
sealant
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with a single complex cryptoglandular perianal fistula

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Informed Consent Form not signed or withdrawn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

Primary outcomes:
measure: Incidence of patients treated following the protocol during the surgery
timeFrame: During the surgery
measure: Incidence of adverse events at 1 month
timeFrame: At 1 month
measure: Incidence of adverse events at 3 months
timeFrame: At 3 months
measure: Incidence of adverse events at 6 months
timeFrame: At 6 months
measure: Incidence of adverse events at 12 months
timeFrame: At 12 months
Secondary outcomes:
measure: Ecographic curation at 12 months
timeFrame: At 12 months
measure: Clinical curation at 1 month
timeFrame: At 1 month
measure: Clinical curation at 3 months
timeFrame: At 3 months
measure: Clinical curation at 6 months
timeFrame: At 6 months
measure: Clinical curation at 12 months
timeFrame: At 12 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Sandra Dios Barbeito
Study officials:
References:
citation: de la Portilla F, Dios-Barbeito S, Maestre-Sanchez MV, Vazquez-Monchul JM, Garcia-Cabrera AM, Ramallo I, Reyes-Diaz ML. Feasibility and safety of calcium alginate hydrogel sealant for the treatment of cryptoglandular fistula-in-ano: phase I/IIa clinical trial. Colorectal Dis. 2021 Jun;23(6):1499-1506. doi: 10.1111/codi.15608. Epub 2021 Mar 20.