Anal FistulaNCT03961984
Long-term Follow-up of Anal Fistula Plug
An observational study of Anal Fistula, run by Region Skane at 1 site in Sweden.
Trial summary
Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Biodesign® anal fistula plug
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteSweden
- Study dates
- May 2006to Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with anal fistulas not treatable with a simple fistulotomy offered to participate.
Who may be able to join
- complex transsphincteric anal fistula
Who cannot join
- ano/rectovaginal fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas
Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.
Read the detailed description
A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.
- Conditions
- Anal Fistula
- Being tested
- Biodesign® anal fistula plug
- Keywords
- anal fistula, fistula-in-ano, surgical plug, collagen plug, complex anal fistula, transsphincteric anal fistula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodesign® anal fistula plugProcedure or surgery
Also called Surgisis anal fistula plug, Collagen plug
Patient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage.
| Study group | Role | What they receive |
|---|---|---|
| Complex anal fistula | Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug. Receives: Procedure: Biodesign® anal fistula plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula recurrence; Technical failure
Plug fallen out
Measured: Week 2
Fistula recurrence; Infection
Surgical site infection
Measured: Week 2
Fistula recurrence; Infection
Surgical site infection
Measured: Month 3
Fistula recurrence; Infection
Surgical site infection
Measured: Month 6-12
Fistula recurrence; Infection
Surgical site infection
Measured: Through study completion, an average of 8 years
Fistula recurrence; New opening
Faeces coming through external opening
Measured: Week 2
Fistula recurrence; New opening
Faeces coming through external opening
Measured: Month 3
Fistula recurrence; New opening
Faeces coming through external opening
Measured: Month 6-12
Fistula recurrence; New opening
Faeces coming through external opening
Measured: Through study completion, an average of 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study startMay 2006
- Primary completionOct 2009
- Study completionOct 2009
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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne Starck, MD, PhD, Study chair, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961984
- Sponsor's protocol ID
- Plug follow-up 2006
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Aho Falt U, Zawadzki A, Starck M, Bohe M, Regner S, Johnson LB. Postoperative three-dimensional endoanal ultrasound findings and relation to anal fistula plug failure. Scand J Gastroenterol. 2023 Jul-Dec;58(10):1200-1206. doi: 10.1080/00365521.2023.2212310. Epub 2023 May 18.
PubMed 37203207
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas
- ClinicalTrials.gov ID
- NCT03961984
- Acronym / sponsor ID
- Plug follow-up 2006
- Conditions
- Anal Fistula
- Keywords
- anal fistula, fistula-in-ano, surgical plug, collagen plug, complex anal fistula, transsphincteric anal fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- May 2006 (actual)
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 May 2019 (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.
Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.
Detailed description
A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex anal fistula | – | Procedure: Biodesign® anal fistula plugPatients with complex transsphincteric anal fistulas were treated with Biodesign® plug. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with anal fistulas not treatable with a simple fistulotomy offered to participate.
Key inclusion criteria (1 listed)
- complex transsphincteric anal fistula
Key exclusion criteria (1 listed)
- ano/rectovaginal fistula
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 |
|---|---|---|
| Biodesign® anal fistula plugAlso: Surgisis anal fistula plug, Collagen plugPatient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage. | Procedure or surgery | Complex anal fistula |
Primary outcome
Fistula recurrence; Technical failure
Time frame: Week 2
Plug fallen out
Fistula recurrence; Infection
Time frame: Week 2
Surgical site infection
Fistula recurrence; Infection
Time frame: Month 3
Surgical site infection
Fistula recurrence; Infection
Time frame: Month 6-12
Surgical site infection
Fistula recurrence; Infection
Time frame: Through study completion, an average of 8 years
Surgical site infection
Fistula recurrence; New opening
Time frame: Week 2
Faeces coming through external opening
Fistula recurrence; New opening
Time frame: Month 3
Faeces coming through external opening
Fistula recurrence; New opening
Time frame: Month 6-12
Faeces coming through external opening
Fistula recurrence; New opening
Time frame: Through study completion, an average of 8 years
Faeces coming through external opening
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 23 May 2019.
- Derived from this study: PubMed 37203207Aho Falt U, Zawadzki A, Starck M, Bohe M, Regner S, Johnson LB. Postoperative three-dimensional endoanal ultrasound findings and relation to anal fistula plug failure. Scand J Gastroenterol. 2023 Jul-Dec;58(10):1200-1206. doi: 10.1080/00365521.2023.2212310. Epub 2023 May 18.
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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.
Marianne Starck, MD, PhD study chair
Region Skane
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 Region Skane 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 1 inclusion and 1 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 23 May 2019. 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?
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?
Fistula recurrence; Technical failure (time frame: Week 2). The study lists 9 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 NCT03961984, 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 23 May 2019.