Perianal FistulaNCT01021774
Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery
A study testing Anal fistula treatment in people with Perianal Fistula, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- Anal fistula treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Jun 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with fistula involving > 1/3 of the external anal sphincter
- Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
- Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
- All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up
Who cannot join
- Fistula tract shorter than 2 cm
- Complex fistula tract system (branching of the fistula tract)
- Age < 18 years
- Pregnancy
- HIV-positivity
- Fistula caused by malignancy
Show all 13Show fewer
- Tuberculosis
- Hidrosadenitis suppurativa
- Pilonidal sinus disease
- No internal fistula opening found
- Unable/contra indications to go through MRI scanning
- Crohn´s disease
- Ulcerative proctitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study
The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.
Read the detailed description
Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.
- Conditions
- Perianal Fistula
- Being tested
- Anal fistula treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal fistula treatmentProcedure or surgery
Also called Perianal, Lambeau technique, Anal fistula plug, Fistula
A comparison of collagen plug vs advancement flap surgery
| Study group | Role | What they receive |
|---|---|---|
| Advancement flap surgery | Active comparator | Not described Receives: Procedure: Anal fistula treatment |
| Collagen plug | Active comparator | Not described Receives: Procedure: Anal fistula treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anorectal fistula closing rate
Measured: 1 year
Secondary outcomes (1)
Quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2015
- Study completionJun 2016
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 Perianal 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, University Hospital, Linkoeping, Region Örebro County
- Responsible party
- Principal investigator, Tom Oresland, University Hospital, Akershus
- Investigators
- Tom Oresland, M.D., Ph.D., Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021774
- Sponsor's protocol ID
- S-08493(REK)
- Status last verified
- Nov 2016
- First submitted
- 27 Nov 2009
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bondi J, Avdagic J, Karlbom U, Hallbook O, Kalman D, Saltyte Benth J, Naimy N, Oresland T. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula. Br J Surg. 2017 Aug;104(9):1160-1166. doi: 10.1002/bjs.10549. Epub 2017 May 10.
PubMed 28489253
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study
- ClinicalTrials.gov ID
- NCT01021774
- Acronym / sponsor ID
- S-08493(REK)
- Conditions
- Perianal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, University Hospital, Linkoeping, Region Örebro County
- Study start
- Nov 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Nov 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.
The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.
Detailed description
Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advancement flap surgery | Active comparator | Procedure: Anal fistula treatment |
| Collagen plug | Active comparator | Procedure: Anal fistula treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with fistula involving > 1/3 of the external anal sphincter
- Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
- Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
- All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up
Key exclusion criteria (13 listed)
- Fistula tract shorter than 2 cm
- Complex fistula tract system (branching of the fistula tract)
- Age < 18 years
- Pregnancy
- HIV-positivity
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 |
|---|---|---|
| Anal fistula treatmentAlso: Perianal, Lambeau technique, Anal fistula plug, FistulaA comparison of collagen plug vs advancement flap surgery | Procedure or surgery | Advancement flap surgery, Collagen plug |
Primary outcome
Anorectal fistula closing rate
Time frame: 1 year
1 secondary outcome
Quality of life
Time frame: 1 year
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 29 Nov 2016.
- Derived from this study: PubMed 28489253Bondi J, Avdagic J, Karlbom U, Hallbook O, Kalman D, Saltyte Benth J, Naimy N, Oresland T. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula. Br J Surg. 2017 Aug;104(9):1160-1166. doi: 10.1002/bjs.10549. Epub 2017 May 10.
Related trials for Perianal Fistula
RecruitingPhase 4
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Crohn Disease, Perianal Fistula
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
Not yet recruitingPhase 4
Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
Perianal Abscess, Anal Fistula
Not yet recruiting
FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)
Perianal Fistula
Recruiting
Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton
Cryptoglandular Perianal Fistula
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.
Tom Oresland, M.D., Ph.D. principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anal fistula treatment in people with Perianal Fistula, run by University Hospital, Akershus at 1 site in Norway.
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 13 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 29 Nov 2016. 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 Norway. 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?
Anorectal fistula closing rate (time frame: 1 year). 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 NCT01021774, 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 29 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.