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

NCT04740086 | Completed DMC

• 1 other identifier: HAS15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

cryptoglandular anal fistula; calcium alginate; sealant

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Ecographic curation at 12 months

  At 12 months

• Clinical curation at 1 month

  At 1 month

• Clinical curation at 3 months

  At 3 months

• Clinical curation at 6 months

  At 6 months

• Clinical curation at 12 months

  At 12 months

Interventions

Calcium alginate hydrogel PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with a single complex cryptoglandular perianal fistula

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sandra Dios Barbeito

Seville, 41013, Spain

Location

Related Publications (1)

• 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.

  PMID: 33655675 DERIVED

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 5, 2021
• Study Start: January 1, 2016
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)