"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 Details — Status: Completed

Administrative data

• NCT number: NCT04740086
• Other study ID #: HAS15
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Informed Consent Form not signed or withdrawn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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• Calcium alginate hydrogel
The external and internal fistulous orifice and fistulous tract were explored without applying any product, including hydrogen peroxide or povidone-iodine. The seton was removed and FT cannulation was performed using a needle for cleaning with a gauze impregnated with saline. Calcium chloride was applied through the EFO until it exits through the IFO, and then the IFO was obturated. Alginate was applied, and the pressure at the IFO was stopped, until the alginate solution partial exits through the IFO. The IFO was closed with a 3/0 braided resorbable suture. The EFO was removed with an electric scalpel and closed with a 3/0 braided resorbable suture.

Locations

Country	Name	City	State
Spain	Sandra Dios Barbeito	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients treated following the protocol 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.	During the surgery
Primary	Incidence of adverse events at 1 month	Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)	At 1 month
Primary	Incidence of adverse events at 3 months	Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)	At 3 months
Primary	Incidence of adverse events at 6 months	Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)	At 6 months
Primary	Incidence of adverse events at 12 months	Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)	At 12 months
Secondary	Ecographic curation 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.	At 12 months
Secondary	Clinical curation 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	At 1 month
Secondary	Clinical curation 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	At 3 months
Secondary	Clinical curation 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	At 6 months
Secondary	Clinical curation 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	At 12 months