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Completed

NCT Number: NCT04740086

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandra Dios Barbeito

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Informed Consent Form not signed or withdrawn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

Treatment and study plan

Calcium alginate hydrogel

Procedure
  • 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.

Primary outcomes

  1. Incidence of patients treated following the protocol during the surgery

    Time frame: 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.

  2. Incidence of adverse events at 1 month

    Time frame: At 1 month

    Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)

  3. Incidence of adverse events at 3 months

    Time frame: At 3 months

    Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)

  4. Incidence of adverse events at 6 months

    Time frame: At 6 months

    Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)

  5. Incidence of adverse events at 12 months

    Time frame: At 12 months

    Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)

Secondary outcomes

  1. Ecographic curation at 12 months

    Time frame: 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.

  2. Clinical curation at 1 month

    Time frame: 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

  3. Clinical curation at 3 months

    Time frame: 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

  4. Clinical curation at 6 months

    Time frame: 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

  5. Clinical curation at 12 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2021
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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