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

Anal Fistula Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04740086
Study type Observational
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact
Status Completed
Phase
Start date January 1, 2016
Completion date November 30, 2019
View Details
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