Anal FistulasPhase 3NCT00929630
Seton or Glue for Trans-sphincteric Anal Fistulas
A Phase 3 study testing transsphincteric Seton positioning, glue (Tissucol) treatment and Fistula closing with biological glue in people with Anal Fistulas, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
Trial summary
Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fistulas
- What is being tested?
- transsphincteric Seton positioning, glue (Tissucol) treatment and Fistula closing with biological glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Jun 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments
Who cannot join
- Crohn's disease
- anal abscesses
- complex fistulas (horse-shoe type or multiple secondary tracts)
- immunosuppression
- diabetes,
- anal fissures
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- pregnancy
- anti-coagulant treatments,
- any allergic reaction to the bioglue components.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept of Emergency and Organ transplantation - University of Bari
Bari, 70124
About this study
Official title: Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial
Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. Furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.In the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the American FDA approved the use and marketing of a human fibrin glue in 1998.
Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%.
Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.
Read the detailed description
Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature are lacking. We will run a prospective randomised trial comparing commercial fibrin glue treatment with classical seton treatment, taking into account the healing rate, hospital stay, healing time, faecal incontinence and postoperative pain.
Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up.
Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the two groups
- Conditions
- Anal Fistulas
- Being tested
- transsphincteric Seton positioning, glue (Tissucol) treatment, Fistula closing with biological glue, Seton positioning into the fistula tract
- Keywords
- fibrin glue, transsphincteric anal fistulas, seton, incontinence, prospective randomised trial
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transsphincteric Seton positioningProcedure or surgery
Also called seton treatment of the fistula
A cutting seton is applied into the fistula tract
glue (Tissucol) treatmentProcedure or surgery
Also called fibrin glue treatment of perianal fistulas
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
Fistula closing with biological glueProcedure or surgery
Also called fibrin glue treatment of perianal fistulas
After cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it
Seton positioning into the fistula tractProcedure or surgery
Also called loose seton, cutting seton for anal fistulas
Under spinal anesthesia a Seton is positioned into the fistula tract.
| Study group | Role | What they receive |
|---|---|---|
| glue (Tissucol ) treatment | Experimental | patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before Receives: Procedure: glue (Tissucol) treatment; Procedure: Fistula closing with biological glue |
| Seton treatment | Active comparator | patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before Receives: Procedure: transsphincteric Seton positioning; Procedure: Seton positioning into the fistula tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula healing (absence of any discharge from the external fistula opening and complete healing of the external fistulas opening after at least 1 year of follow-up). The analysis of the population is not intention to treat.
Measured: 12 months
Secondary outcomes (1)
Fecal continence and in-hospital stay
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 posted29 Jun 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2007
- Study completionJun 2007
Why it stopped: Evident advantages of one treatment (seton) over the other (Tissucol Glue)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulasStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Investigators
- Donato F Altomare, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929630
- Sponsor's protocol ID
- SICCR 10/2006
- Status last verified
- Sep 2009
- First submitted
- 30 Mar 2009
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00929630
- Acronym / sponsor ID
- SICCR 10/2006
- Conditions
- Anal Fistulas
- Keywords
- fibrin glue, transsphincteric anal fistulas, seton, incontinence, prospective randomised trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evident advantages of one treatment (seton) over the other (Tissucol Glue)
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Study start
- Jan 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 29 Jun 2009 (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.
Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. Furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.In the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the American FDA approved the use and marketing of a human fibrin glue in 1998.
Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%.
Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.
Detailed description
Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature are lacking. We will run a prospective randomised trial comparing commercial fibrin glue treatment with classical seton treatment, taking into account the healing rate, hospital stay, healing time, faecal incontinence and postoperative pain.
Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up.
Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glue (Tissucol ) treatment | Experimental | Procedure: glue (Tissucol) treatment, Procedure: Fistula closing with biological gluepatients with transsphincteric anal fistulas of cryptoglandular origin never operated on before |
| Seton treatment | Active comparator | Procedure: transsphincteric Seton positioning, Procedure: Seton positioning into the fistula tractpatients with transsphincteric anal fistulas of cryptoglandular origin never operated on before |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments
Key exclusion criteria (9 listed)
- Crohn's disease
- anal abscesses
- complex fistulas (horse-shoe type or multiple secondary tracts)
- immunosuppression
- diabetes,
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 |
|---|---|---|
| transsphincteric Seton positioningAlso: seton treatment of the fistulaA cutting seton is applied into the fistula tract | Procedure or surgery | Seton treatment |
| glue (Tissucol) treatmentAlso: fibrin glue treatment of perianal fistulasAfter preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract | Procedure or surgery | glue (Tissucol ) treatment |
| Fistula closing with biological glueAlso: fibrin glue treatment of perianal fistulasAfter cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it | Procedure or surgery | glue (Tissucol ) treatment |
| Seton positioning into the fistula tractAlso: loose seton, cutting seton for anal fistulasUnder spinal anesthesia a Seton is positioned into the fistula tract. | Procedure or surgery | Seton treatment |
Primary outcome
Fistula healing (absence of any discharge from the external fistula opening and complete healing of the external fistulas opening after at least 1 year of follow-up). The analysis of the population is not intention to treat.
Time frame: 12 months
1 secondary outcome
Fecal continence and in-hospital stay
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Evident advantages of one treatment (seton) over the other (Tissucol Glue)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
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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.
Donato F Altomare, MD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transsphincteric Seton positioning, glue (Tissucol) treatment and Fistula closing with biological glue in people with Anal Fistulas, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
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 9 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: stopped early, as of the sponsor's last update on 16 Sep 2009. 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 Italy. 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 was stopped early (reason given: Evident advantages of one treatment (seton) over the other (Tissucol Glue)). 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?
Fistula healing (absence of any discharge from the external fistula opening and complete healing of the external fistulas opening after at least 1 year of follow-up). The analysis of the population is not intention to treat. (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 16 Sep 2009.