Anorectal FistulaNCT01913249
Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula
A study testing LIFT in people with Anorectal Fistula, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anorectal Fistula
- What is being tested?
- LIFT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2013to 17 Apr 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 65 years
- Complex anal fistula defined as
- anterior fistulas in women
- branched fistulas
- fistulas in patients with anal incontinence
- fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division.
Who cannot join
- Crohn's disease in the rectum
- Previous LIFT surgery on same side
- Patient already treated with seton > 3 weeks
- Not able or willing to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.
The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.
- Conditions
- Anorectal Fistula
- Being tested
- LIFT
- Keywords
- Anorectal fistula, LIFT, 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.
LIFTProcedure or surgery
Ligation of intersphincteric fistula tract
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Seton through fistula 6 months prior to LIFT Receives: Procedure: LIFT |
| Control | Active comparator | Seton through fistula 3 weeks prior to LIFT surgery Receives: Procedure: LIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence or non-healing of anal fistula one year after LIFT surgery
Measured: 1 year
Complication
Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
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 posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2018
- Study completion17 Apr 2018
Why it stopped: Unable to get MRI of patients within reasonable time on a local hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913249
- Sponsor's protocol ID
- 2013/581(REK)
- Status last verified
- Sep 2013
- First submitted
- 29 Jul 2013
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01913249
- Acronym / sponsor ID
- 2013/581(REK)
- Conditions
- Anorectal Fistula
- Keywords
- Anorectal fistula, LIFT, Seton
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to get MRI of patients within reasonable time on a local hospital.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 1 Aug 2013 (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 aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: LIFTSeton through fistula 6 months prior to LIFT |
| Control | Active comparator | Procedure: LIFTSeton through fistula 3 weeks prior to LIFT surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 20 and 65 years
- Complex anal fistula defined as
Key exclusion criteria (4 listed)
- Crohn's disease in the rectum
- Previous LIFT surgery on same side
- Patient already treated with seton > 3 weeks
- Not able or willing to sign informed consent
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 |
|---|---|---|
| LIFTLigation of intersphincteric fistula tract | Procedure or surgery | Control, Intervention |
Primary outcome
Recurrence rate
Time frame: 1 year
Recurrence or non-healing of anal fistula one year after LIFT surgery
Complication
Time frame: 1 year
Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT in people with Anorectal Fistula, run by Sykehuset Innlandet HF 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Apr 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Recurrence rate (time frame: 1 year). 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?
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 19 Apr 2018.