Anal FistulaAdiTiFNCT04790123
Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula
A study testing Injection of autologous freshly collected adipose tissue in people with Anal Fistula, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Injection of autologous freshly collected adipose tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2020to Oct 2024
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Anal fistula with suppuration for more than 6 weeks and less than 1 year, that have not received any previous treatment or at most: curettage and drainage placement
- Complex cryptoglandular anal fistula: medium or high transsphincteric fistula, suprasphincteric fistula and extra sphincter fistula, shown by endoanal ultrasound.
- Low transsphincteric fistulas in patients with fecal incotinence.
- Any cryptoglandular anal fistula with risk factors for anal incontinence: anterior location fistula in women, history of pelvic surgery (hysterectomy, rectal resection), history of pelvic radiotherapy or previous anal surgery
- Draining with Seton placed >2 weeks before surgery and present at the time of treatment
- Disposition and ability to comply with the study protocol
- Signed informed consent
Who cannot join
- Patients diagnosed with inflammatory bowel disease
- Previous history of perianal fistula treated with any surgery different than curettage and seton placement (this include any type of surgery with curative intention, i.e. flap, lift technique, Radiofrequency, laser, stem cells, Filac, etc)
- Presence of Rectovaginal fistula
- Technical impossibility for lipoaspirate (liposuction) technique.
- Presence of perianal collections larger than 2cm
- Presence of several paths from 1 internal hole only
Show all 14Show fewer
- Presence of secondary fistula paths or tracts
- Perianal surgery necessary at the time of planning the fistula treatment, for reasons other than fistula.
- Major surgery needed within 28 days of recruitment
- Immunomodulator treatment or corticotherapy in a previous period of 6 months
- Stoma patients
- Serious medical or psychiatric illness that requires frequent hospitalization.
- Pregnancy, pregnancy plans or breastfeeding in the next 12 months
- Active smokers, or ex-smokers of less than 3 months
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221
Pilar Arcusa, 937365050, parcusa@mutuaterrassa.es
About this study
The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its treatment remains a real challenge due to the limited efficacy of sphincter preservation techniques and the inevitable risk of faecal incontinence in those cases that require surgery. Goals: To evaluate the efficacy and safety of the injection of freshly collected autologous adipose tissue as a minimally invasive, highly reproducible alternative, without risk for the continence of the patient, and of very low cost, in the treatment of complex cryptoglandular anal fistula. Methodology: Prospective multicenter, randomized, double-blinded, parallel-group, placebo-controlled clinical trial. Randomization list for each center to ensure the balance of inter-center allocation. Patients older than 18 years with cryptoglandular anal fistula with suppuration for more than 6 weeks and less than 1 year, who have received at most: curettage and drainage placement will be included. Treatment group: injection of fresh autologous fat into the fistulous tract, after curettage and closure of the internal orifice, and after lipoaspirate fat in the abdomen and centrifugation thereof. Placebo group: curettage and closure of the internal orifice and simulated intervention in the abdomen. Evaluation: protocolized clinical history and fistula complexity score (CFS), subjective perception of its pathology, St.Marks continence score, Quality of life questionnaire (QoLAF), and endoanal 3D ultrasound, at baseline, at one week, and at 3, 6 and 12 months after the intervention. The patients and the evaluator will be blind to the treatment. Patients who cannot end up receiving treatment due to intraoperative incidents or medical decision will be excluded from the study (post randomization exclusion). In each center there will be a blind evaluator to perform the follow-ups and endoanal ultrasound.
- Conditions
- Anal Fistula
- Being tested
- Injection of autologous freshly collected adipose tissue, sham
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous freshly collected adipose tissueProcedure or surgery
injection of fresh autologous fat, previously lipoaspirates from the patient's abdomen and centrifugated, into the fistulous tract, after curettage and closure of the internal opening.
shamProcedure or surgery
curettage and closure of the internal orifice of the anal fistula and simulated intervention in the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Not described Receives: Procedure: sham |
| Experimental group | Experimental | Not described Receives: Procedure: Injection of autologous freshly collected adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete fistula healing
Comparison of the proportion of cases with complete fistula healing within 24 weeks of the intervention, defined as the absence of drainage through the external orifice, its complete reepithelialization and the absence of collections confirmed by endoanal ultrasound.
Measured: 24 weeks
Secondary outcomes (4)
Patient's Quality of life
Improvement in quality of life (measured with the Quality of Life in Patients with Anal Fistula Questionnaire, QoLAF).
Score from 14 to 70, where 14 means "no quality of life alteration" and 70 means "severe quality of life alteration".
Measured: 6 and 12 months after treatment.
Patient's Subjective Perception
Improvement in patient subjective evaluation using a Visual Analogue Scale (VAS).
Score from 0 to 10, where 0 means "no problem" and 10 means "severe problem and alteration of my quality of life".
Measured: 6 and 12 months after treatment.
Fistula severity
Improvement in fistula severity according to the Complexity Fistula score (CFS).
Score from 3 to 15, where 3 means "low complexity" and 15 means "high complexity"
Measured: 6 and 12 months after treatment.
Adverse events
Evaluation of the safety by the incidence of adverse events and serious adverse events.
Measured: 3, 6 and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start14 Oct 2020
- Primary completion14 Nov 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arantxa Muñoz-Duyos, Hospital Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790123
- Sponsor's protocol ID
- P19/035
- Acronym
- AdiTiF
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula
- ClinicalTrials.gov ID
- NCT04790123
- Acronym / sponsor ID
- AdiTiF / P19/035
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 14 Nov 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Mar 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.
The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its treatment remains a real challenge due to the limited efficacy of sphincter preservation techniques and the inevitable risk of faecal incontinence in those cases that require surgery. Goals: To evaluate the efficacy and safety of the injection of freshly collected autologous adipose tissue as a minimally invasive, highly reproducible alternative, without risk for the continence of the patient, and of very low cost, in the treatment of complex cryptoglandular anal fistula. Methodology: Prospective multicenter, randomized, double-blinded, parallel-group, placebo-controlled clinical trial. Randomization list for each center to ensure the balance of inter-center allocation. Patients older than 18 years with cryptoglandular anal fistula with suppuration for more than 6 weeks and less than 1 year, who have received at most: curettage and drainage placement will be included. Treatment group: injection of fresh autologous fat into the fistulous tract, after curettage and closure of the internal orifice, and after lipoaspirate fat in the abdomen and centrifugation thereof. Placebo group: curettage and closure of the internal orifice and simulated intervention in the abdomen. Evaluation: protocolized clinical history and fistula complexity score (CFS), subjective perception of its pathology, St.Marks continence score, Quality of life questionnaire (QoLAF), and endoanal 3D ultrasound, at baseline, at one week, and at 3, 6 and 12 months after the intervention. The patients and the evaluator will be blind to the treatment. Patients who cannot end up receiving treatment due to intraoperative incidents or medical decision will be excluded from the study (post randomization exclusion). In each center there will be a blind evaluator to perform the follow-ups and endoanal ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: sham |
| Experimental group | Experimental | Procedure: Injection of autologous freshly collected adipose tissue |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients over 18 years
- Anal fistula with suppuration for more than 6 weeks and less than 1 year, that have not received any previous treatment or at most: curettage and drainage placement
- Complex cryptoglandular anal fistula: medium or high transsphincteric fistula, suprasphincteric fistula and extra sphincter fistula, shown by endoanal ultrasound.
- Low transsphincteric fistulas in patients with fecal incotinence.
- Any cryptoglandular anal fistula with risk factors for anal incontinence: anterior location fistula in women, history of pelvic surgery (hysterectomy, rectal resection), history of pelvic radiotherapy or previous anal surgery
Key exclusion criteria (14 listed)
- Patients diagnosed with inflammatory bowel disease
- Previous history of perianal fistula treated with any surgery different than curettage and seton placement (this include any type of surgery with curative intention, i.e. flap, lift technique, Radiofrequency, laser, stem cells, Filac, etc)
- Presence of Rectovaginal fistula
- Technical impossibility for lipoaspirate (liposuction) technique.
- Presence of perianal collections larger than 2cm
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 |
|---|---|---|
| Injection of autologous freshly collected adipose tissueinjection of fresh autologous fat, previously lipoaspirates from the patient's abdomen and centrifugated, into the fistulous tract, after curettage and closure of the internal opening. | Procedure or surgery | Experimental group |
| shamcurettage and closure of the internal orifice of the anal fistula and simulated intervention in the abdomen. | Procedure or surgery | Control group |
Primary outcome
Complete fistula healing
Time frame: 24 weeks
Comparison of the proportion of cases with complete fistula healing within 24 weeks of the intervention, defined as the absence of drainage through the external orifice, its complete reepithelialization and the absence of collections confirmed by endoanal ultrasound.
4 secondary outcomes
Patient's Quality of life
Time frame: 6 and 12 months after treatment.
Patient's Subjective Perception
Time frame: 6 and 12 months after treatment.
Fistula severity
Time frame: 6 and 12 months after treatment.
Adverse events
Time frame: 3, 6 and 12 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of autologous freshly collected adipose tissue in people with Anal Fistula, run by Hospital Mutua de Terrassa 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 8 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete fistula healing (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.