Anal FistulaSurgisis® AFPNCT00545441
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
A study testing Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) and Flap in people with Anal Fistula, run by Cook Group Incorporated at 6 sites in Germany.
Trial summary
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure. 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?
- Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) and Flap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 6 sitesGermany
- Study dates
- Jun 2008to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Over eighteen years old
- Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
- Pre-placement of seton required for at least 6 weeks prior to surgical treatment
- Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer
Who cannot join
- Recurrent fistula tracts
- J-pouch fistulas
- Superficial fistulas
- Fistulas with active abscess, infection, or acute inflammation
- History of Chron's Disease
- History of Ulcerative Colitis
Show all 11Show fewer
- History of HIV or other immune system disease
- History of collagen disease
- History of radiation to the anorectal region
- Allergies to pig tissue or pig products
- Religious or cultural objection to the use of pig tissue
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Krankenhaus Waldfriede
Berlin
Justus-Liebig-Universitat Giessen
Giessen, Giessen, 35385
End-und Dickdarmzentrum Hannover
Hanover
Enddarmzentrum Mannheim
Mannheim
Caritas-Krankenhaus St. Joseph
Regensburg
St. Joseph Hospital
Wiesbaden
About this study
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
- Conditions
- Anal Fistula
- Being tested
- Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP), Flap
- Keywords
- Anal fistula, fistula in ano, anorectal 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.
Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)Device
Also called Surgisis Biodesign
Surgical placement of the Surgisis AFP is performed under general anesthesia.
FlapDevice
Advancement flap surgery is performed; no anal fistula plug is placed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Surgisis® AFP Receives: Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) |
| 2 | Active comparator | Flap Receives: Device: Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Success
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJun 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated, Cook Ireland, Ltd.
- Responsible party
- Sponsor
- Investigators
- Thilo Schwandner, MD, Principal investigator, Justus-Liebig-Universitat Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545441
- Sponsor's protocol ID
- 07-006
- Acronym
- Surgisis® AFP
- Status last verified
- Dec 2014
- First submitted
- 16 Oct 2007
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
- ClinicalTrials.gov ID
- NCT00545441
- Acronym / sponsor ID
- Surgisis® AFP / 07-006
- Conditions
- Anal Fistula
- Keywords
- Anal fistula, fistula in ano, anorectal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated, Cook Ireland, Ltd.
- Study start
- Jun 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)Surgisis® AFP |
| 2 | Active comparator | Device: FlapFlap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over eighteen years old
- Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
- Pre-placement of seton required for at least 6 weeks prior to surgical treatment
- Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer
Key exclusion criteria (11 listed)
- Recurrent fistula tracts
- J-pouch fistulas
- Superficial fistulas
- Fistulas with active abscess, infection, or acute inflammation
- History of Chron's Disease
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 |
|---|---|---|
| Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)Also: Surgisis BiodesignSurgical placement of the Surgisis AFP is performed under general anesthesia. | Device | 1 |
| FlapAdvancement flap surgery is performed; no anal fistula plug is placed | Device | 2 |
Primary outcome
Healing Success
Time frame: 12 months
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thilo Schwandner, MD principal investigator
Justus-Liebig-Universitat Giessen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) and Flap in people with Anal Fistula, run by Cook Group Incorporated at 6 sites in Germany.
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 4 inclusion and 11 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Healing Success (time frame: 12 months). 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 17 Dec 2014.