Anal FistulaNCT04740086
"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"
An observational study of Anal Fistula, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Calcium alginate hydrogel
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients with a single complex cryptoglandular perianal fistula
Who may be able to join
- 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
Who cannot join
- Informed Consent Form not signed or withdrawn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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
- Conditions
- Anal Fistula
- Being tested
- Calcium alginate hydrogel
- Keywords
- cryptoglandular anal fistula, calcium alginate, sealant
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium alginate hydrogelProcedure or surgery
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At 12 months
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jan 2016
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740086
- Sponsor's protocol ID
- HAS15
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33655675
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano"
- ClinicalTrials.gov ID
- NCT04740086
- Acronym / sponsor ID
- HAS15
- Conditions
- Anal Fistula
- Keywords
- cryptoglandular anal fistula, calcium alginate, sealant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Jan 2016
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with a single complex cryptoglandular perianal fistula
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium alginate hydrogel1. 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. | Procedure or surgery | – |
Primary outcome
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.
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)
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)
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)
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)
5 secondary outcomes
Ecographic curation at 12 months
Time frame: At 12 months
Clinical curation at 1 month
Time frame: At 1 month
Clinical curation at 3 months
Time frame: At 3 months
Clinical curation at 6 months
Time frame: At 6 months
Clinical curation at 12 months
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 33655675de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients treated following the protocol during the surgery (time frame: During the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.