Fistula in AnoNCT04660903
Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation
A study testing Autologous fat cell transplantation in people with Fistula in Ano and Transsphincteric Anal Fistula, run by Konstantinos Tsimogiannis at 1 site in Sweden.
Trial summary
This is a prospective interventional study on the treatment of transsphincteric fistula in ano. After abdominal or thigh liposuction, fat was injected around the fistula tract that was then transected percutaneously with a sharp cannula and fat injected between and around the cut parts. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fistula in Ano, Transsphincteric Anal Fistula
- What is being tested?
- Autologous fat cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2020to 28 Feb 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Verified perianal or rectovaginal fistula
- Healthy individuals that can be accepted for an elective operation with total anesthesia.
- Signed consent
Who cannot join
- Patients under the age of 18 or over the age of 75 years
- Another disease that can affect the perianal are or the procedure
- Patients that are not able to understand and sign the consent themselves.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective interventional study on the treatment of transsphincteric fistula in ano. After abdominal or thigh liposuction, fat was injected around the fistula tract that was then transected percutaneously with a sharp cannula and fat injected between and around the cut parts. The internal opening was closed with a suture. Minimum follow up of 12 months is planed
Read the detailed description
The study is intended to be carried out at the Department of Surgery of Uppsala University Hospital, as a single-center study. All (consecutive) otherwise healthy patients between the ages of 18-70 who have been diagnosed with perianal fistula where attempts to close the fistula is considered appropriate are asked to participate. This is done by the examining physician at their visit at the outpatient clinic. These are either patients who already have a relieving seton or those who need to be revised and treated with a seton before final closure.
They receive written information about the study plan and have time to think about it. If they choose to participate in the study, they are planed for a visit to one of the surgeons involved in the study and here get another opportunity to ask questions and then also sign an informed consent. This step can be adjusted as telephone contact due to the Covid-19 pandemic. Thereafter, they are included in the study.
The participants are operated on only by the surgeons involved, all of whom have undergone practical training in how fat cell transplantation is carried out according to the standardized Coleman method.
The procedure itself then takes place as a day surgery operation at the Samariter Hemmet ( part of the Surgical Department, Uppsala University Hospital ) operating department and either as a one- or two-step procedure, depending on whether they have a relieving seton or not. The seton has to be placed sometime before the definitive fatty tissue procedure so that there is no sign of inflammation/infection.
A 3- and 12-months follow up visit is then arranged. In these visits, the patients are examined for evaluation of the result, possible residual fistulas, and complications. Wexner score and VAS scale are filed in and saved in their patient files.
- Conditions
- Fistula in Ano, Transsphincteric Anal Fistula
- Being tested
- Autologous fat cell transplantation
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat cell transplantationProcedure or surgery
Up to 75 ml of fatty tissue mixture fluid
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | One arm study - the intervention arm is the only actual Receives: Procedure: Autologous fat cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing of fistula in ano
No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic
Measured: 3 months after index operation
Clinical healing of fistula in ano
No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic
Measured: 12 months after index operation
Postoperative complication
Possible complications linked to index operation
Measured: 3 months after index operation
Postoperative complication
Possible complications linked to index operation
Measured: 12 months after index operation
Secondary outcomes (7)
Functional effects
Incontinence or constipation after index operation that will be assessed with Wexner score ( On a scale of 0-20, with 0 = perfect continence and 20 = complete incontinence ).
Measured: 3 months after index operation
Functional effects
Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis
Measured: 3 months after index operation
Functional effects
Incontinence or constipation after index operation that will be assessed with Wexner score ( On a scale of 0-20, with 0 = perfect continence and 20 = complete incontinence )
Measured: 12 months after index operation
Functional effects
Studied with a calendar with stool frequency and consistency, filled by patients for descriptive analysis
Measured: 12 months after index operation
Injected fat quantity
The quantity of fat cell mixture injected per patient
Measured: During index operation
Visual Analog Pain Scale score
Pain or discomfort after the treatment, using Visual analog scale, for the first 3 weeks of the postoperative period. The scale ranges from 0 8 no pain ) to 10 ( maximum possible pain )
Measured: 3 months after index operation
Visual Analog Pain Scale score
Pain or discomfort after the treatment, using Visual analog scale, for the first 3 weeks of the postoperative period. The scale ranges from 0 8 no pain ) to 10 ( maximum possible pain )
Measured: 12 months after index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Oct 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Why it stopped: Severe adverse reaction on patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fistula in AnoStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konstantinos Tsimogiannis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Konstantinos Tsimogiannis, Uppsala University Hospital
- Investigators
- Wilhelm Graf, Professor, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660903
- Sponsor's protocol ID
- Fettcell studie
- Status last verified
- Jun 2022
- First submitted
- 22 Nov 2020
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by the ethical committee and data legislations. If this is required, completion of the Ethical decision is needed
Publications
Choi S, Ryoo SB, Park KJ, Kim DS, Song KH, Kim KH, Chung SS, Shin EJ, Cho YB, Oh ST, Kang WK, Kim MH. Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn's disease: a phase II clinical trial for safety and efficacy. Tech Coloproctol. 2017 May;21(5):345-353. doi: 10.1007/s10151-017-1630-z. Epub 2017 May 31.
PubMed 28567691Norderval S, Lundby L, Hougaard H, Buntzen S, Weum S, de Weerd L. Efficacy of autologous fat graft injection in the treatment of anovaginal fistulas. Tech Coloproctol. 2018 Jan;22(1):45-51. doi: 10.1007/s10151-017-1739-0. Epub 2017 Dec 28.
PubMed 29285682Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.
PubMed 22706128Dozois EJ, Lightner AL, Mathis KL, Chua HK, Kelley SR, Fletcher JG, Dietz AB, Friton JJ, Butler GW, Faubion WA. Early Results of a Phase I Trial Using an Adipose-Derived Mesenchymal Stem Cell-Coated Fistula Plug for the Treatment of Transsphincteric Cryptoglandular Fistulas. Dis Colon Rectum. 2019 May;62(5):615-622. doi: 10.1097/DCR.0000000000001333.
PubMed 30664554Pu LLQ, Coleman SR, Cui X, Ferguson REH Jr, Vasconez HC. Autologous fat grafts harvested and refined by the Coleman technique: a comparative study. Plast Reconstr Surg. 2008 Sep;122(3):932-937. doi: 10.1097/PRS.0b013e3181811ff0.
PubMed 18766062Borowski DW, Gill TS, Agarwal AK, Tabaqchali MA, Garg DK, Bhaskar P. Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique. Surg Innov. 2015 Dec;22(6):593-600. doi: 10.1177/1553350615572656. Epub 2015 Feb 20.
PubMed 25710946
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation
- ClinicalTrials.gov ID
- NCT04660903
- Acronym / sponsor ID
- Fettcell studie
- Conditions
- Fistula in Ano, Transsphincteric Anal Fistula
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Severe adverse reaction on patient
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Konstantinos TsimogiannisUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 9 Dec 2020 (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.
This is a prospective interventional study on the treatment of transsphincteric fistula in ano. After abdominal or thigh liposuction, fat was injected around the fistula tract that was then transected percutaneously with a sharp cannula and fat injected between and around the cut parts. The internal opening was closed with a suture. Minimum follow up of 12 months is planed
Detailed description
The study is intended to be carried out at the Department of Surgery of Uppsala University Hospital, as a single-center study. All (consecutive) otherwise healthy patients between the ages of 18-70 who have been diagnosed with perianal fistula where attempts to close the fistula is considered appropriate are asked to participate. This is done by the examining physician at their visit at the outpatient clinic. These are either patients who already have a relieving seton or those who need to be revised and treated with a seton before final closure.
They receive written information about the study plan and have time to think about it. If they choose to participate in the study, they are planed for a visit to one of the surgeons involved in the study and here get another opportunity to ask questions and then also sign an informed consent. This step can be adjusted as telephone contact due to the Covid-19 pandemic. Thereafter, they are included in the study.
The participants are operated on only by the surgeons involved, all of whom have undergone practical training in how fat cell transplantation is carried out according to the standardized Coleman method.
The procedure itself then takes place as a day surgery operation at the Samariter Hemmet ( part of the Surgical Department, Uppsala University Hospital ) operating department and either as a one- or two-step procedure, depending on whether they have a relieving seton or not. The seton has to be placed sometime before the definitive fatty tissue procedure so that there is no sign of inflammation/infection.
A 3- and 12-months follow up visit is then arranged. In these visits, the patients are examined for evaluation of the result, possible residual fistulas, and complications. Wexner score and VAS scale are filed in and saved in their patient files.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Autologous fat cell transplantationOne arm study - the intervention arm is the only actual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Verified perianal or rectovaginal fistula
- Healthy individuals that can be accepted for an elective operation with total anesthesia.
- Signed consent
Key exclusion criteria (3 listed)
- Patients under the age of 18 or over the age of 75 years
- Another disease that can affect the perianal are or the procedure
- Patients that are not able to understand and sign the consent themselves.
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 |
|---|---|---|
| Autologous fat cell transplantationUp to 75 ml of fatty tissue mixture fluid | Procedure or surgery | Intervention |
Primary outcome
Clinical healing of fistula in ano
Time frame: 3 months after index operation
No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic
Clinical healing of fistula in ano
Time frame: 12 months after index operation
No fistula opening and no fistula related symptoms on clinical examination and with anal ultrasound at the outpatient clinic
Postoperative complication
Time frame: 3 months after index operation
Possible complications linked to index operation
Postoperative complication
Time frame: 12 months after index operation
Possible complications linked to index operation
7 secondary outcomes
Functional effects
Time frame: 3 months after index operation
Functional effects
Time frame: 3 months after index operation
Functional effects
Time frame: 12 months after index operation
Functional effects
Time frame: 12 months after index operation
Injected fat quantity
Time frame: During index operation
Visual Analog Pain Scale score
Time frame: 3 months after index operation
Visual Analog Pain Scale score
Time frame: 12 months after index operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 28567691Choi S, Ryoo SB, Park KJ, Kim DS, Song KH, Kim KH, Chung SS, Shin EJ, Cho YB, Oh ST, Kang WK, Kim MH. Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn's disease: a phase II clinical trial for safety and efficacy. Tech Coloproctol. 2017 May;21(5):345-353. doi: 10.1007/s10151-017-1630-z. Epub 2017 May 31.
- Background: PubMed 29285682Norderval S, Lundby L, Hougaard H, Buntzen S, Weum S, de Weerd L. Efficacy of autologous fat graft injection in the treatment of anovaginal fistulas. Tech Coloproctol. 2018 Jan;22(1):45-51. doi: 10.1007/s10151-017-1739-0. Epub 2017 Dec 28.
- Background: PubMed 22706128Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.
- Background: PubMed 30664554Dozois EJ, Lightner AL, Mathis KL, Chua HK, Kelley SR, Fletcher JG, Dietz AB, Friton JJ, Butler GW, Faubion WA. Early Results of a Phase I Trial Using an Adipose-Derived Mesenchymal Stem Cell-Coated Fistula Plug for the Treatment of Transsphincteric Cryptoglandular Fistulas. Dis Colon Rectum. 2019 May;62(5):615-622. doi: 10.1097/DCR.0000000000001333.
- Background: PubMed 18766062Pu LLQ, Coleman SR, Cui X, Ferguson REH Jr, Vasconez HC. Autologous fat grafts harvested and refined by the Coleman technique: a comparative study. Plast Reconstr Surg. 2008 Sep;122(3):932-937. doi: 10.1097/PRS.0b013e3181811ff0.
- Background: PubMed 25710946Borowski DW, Gill TS, Agarwal AK, Tabaqchali MA, Garg DK, Bhaskar P. Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique. Surg Innov. 2015 Dec;22(6):593-600. doi: 10.1177/1553350615572656. Epub 2015 Feb 20.
- Individual participant dataSharing planned: No. Not allowed by the ethical committee and data legislations. If this is required, completion of the Ethical decision is needed
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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.
Wilhelm Graf, Professor study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous fat cell transplantation in people with Fistula in Ano and Transsphincteric Anal Fistula, run by Konstantinos Tsimogiannis at 1 site in Sweden.
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 3 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: paused, as of the sponsor's last update on 13 Jun 2022. 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 Sweden. 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?
Results are not available in the source record.
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?
Clinical healing of fistula in ano (time frame: 3 months after index operation). The study lists 4 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 NCT04660903, which also lists 6 linked publications.
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 13 Jun 2022.