"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"

NCT ID: NCT04740086

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-11-30

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.

Conditions

Anal Fistula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Calcium alginate hydrogel

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.

Intervention Type: PROCEDURE

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• Informed Consent Form not signed or withdrawn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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sandra Dios Barbeito

Seville, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33655675 (View on PubMed)

Other Identifiers

HAS15

Identifier Type: -

Identifier Source: org_study_id