"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"

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.

Study Overview

• Status: Completed
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: Calcium alginate hydrogel

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41013
    • Sandra Dios Barbeito

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

20 patients with a single complex cryptoglandular perianal fistula

Description

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• Informed Consent Form not signed or withdrawn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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: sealant; cryptoglandular anal fistula; calcium alginate
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: HAS15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No