Anal FistulaPhase 3NCT00450671
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
A Phase 3 study testing Collagen Plug Placement and Seton placement in people with Anal Fistula, run by University of Southern California at 4 sites in United States.
Trial summary
The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method. 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?
- Collagen Plug Placement and Seton placement
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2007to 9 May 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group
- Patients that are older than 18 years of age and are able to understand and sign consent
- Patients that are suitable candidates for either seton or collagen plug placement
Who cannot join
- Preoperative patient exclusion factors:
- Pregnant patients
- Patients with a tumor-related fistula
- Patients with known allergies to porcine products
- Patients with known Crohn's disease
- Intraoperative patient exclusion factors:
Show all 10Show fewer
- Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery
- Patients with a large diameter fistula (>3mm)
- Patients with a superficial fistula
- Patients with a short fistula (<1 cm in length)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
H.Claude Hudson Comprehensive Health Center
Los Angeles, California, 90007
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC Norris Cancer Center
Los Angeles, California, 90033
USC/University Hospital
Los Angeles, California, 90033
About this study
Official title: Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
Read the detailed description
Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue).
Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method.
The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.
- Conditions
- Anal Fistula
- Being tested
- Collagen Plug Placement, Seton placement
- Keywords
- Fistula-in-ano, Anal fistula, Perirectal fistula, Collagen plug, Surgisis, Seton
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Plug PlacementProcedure or surgery
Seton placementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula healing
Treatment failure
Secondary outcomes (3)
Time to fistula healing
Time to treatment failure
Rates of postoperative fecal continence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startFeb 2007
- Study completion9 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas M Kaiser, MD, Principal investigator, University of Southern California Department of Colorectal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450671
- Sponsor's protocol ID
- Seton vs. Surgisis
- Other IDs
- HS-06-00342
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2007
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zmora O, Neufeld D, Ziv Y, Tulchinsky H, Scott D, Khaikin M, Stepansky A, Rabau M, Koller M. Prospective, multicenter evaluation of highly concentrated fibrin glue in the treatment of complex cryptogenic perianal fistulas. Dis Colon Rectum. 2005 Dec;48(12):2167-72. doi: 10.1007/s10350-005-0199-1.
PubMed 16258708Champagne BJ, O'Connor LM, Ferguson M, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum. 2006 Dec;49(12):1817-21. doi: 10.1007/s10350-006-0755-3.
PubMed 17082891Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. doi: 10.1007/s10350-005-0288-1.
PubMed 16421664
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00450671
- Acronym / sponsor ID
- Seton vs. Surgisis
- Conditions
- Anal Fistula
- Keywords
- Fistula-in-ano, Anal fistula, Perirectal fistula, Collagen plug, Surgisis, Seton
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- 9 May 2013 (actual)
- First posted
- 22 Mar 2007 (estimated)
- 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 purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
Detailed description
Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue).
Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method.
The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group
- Patients that are older than 18 years of age and are able to understand and sign consent
- Patients that are suitable candidates for either seton or collagen plug placement
Key exclusion criteria (10 listed)
- Preoperative patient exclusion factors:
- Intraoperative patient exclusion factors:
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 |
|---|---|---|
| Collagen Plug Placement | Procedure or surgery | – |
| Seton placement | Procedure or surgery | – |
Primary outcome
Fistula healing
Treatment failure
3 secondary outcomes
Time to fistula healing
Time to treatment failure
Rates of postoperative fecal continence
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 17 Mar 2017.
- Background: PubMed 16258708Zmora O, Neufeld D, Ziv Y, Tulchinsky H, Scott D, Khaikin M, Stepansky A, Rabau M, Koller M. Prospective, multicenter evaluation of highly concentrated fibrin glue in the treatment of complex cryptogenic perianal fistulas. Dis Colon Rectum. 2005 Dec;48(12):2167-72. doi: 10.1007/s10350-005-0199-1.
- Background: PubMed 17082891Champagne BJ, O'Connor LM, Ferguson M, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum. 2006 Dec;49(12):1817-21. doi: 10.1007/s10350-006-0755-3.
- Background: PubMed 16421664Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. doi: 10.1007/s10350-005-0288-1.
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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.
Andreas M Kaiser, MD principal investigator
University of Southern California Department of Colorectal Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagen Plug Placement and Seton placement in people with Anal Fistula, run by University of Southern California at 4 sites in United States.
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 10 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 healing. The study lists 2 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 NCT00450671, which also lists 3 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 17 Mar 2017.