NCT04740086

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

"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2021-02-05
• Last updated: 2021-02-05

Locations

1 site across 1 country: Spain