Anal FistulaAFPERAFNCT01931371
Anal Fistula Plug Versus Endorectal Advancement Flap
A study testing Anal Fistula Plug and Endorectal Advancement Flap in people with Anal Fistula, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Anal Fistula Plug and Endorectal Advancement Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Oct 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years of age or more)
- Single anal fistula
- Surgically treated with anal fistula plug or endorectal advancement flap
Who cannot join
- Children or adolescents
- Pregnancy
- Patients treated with setons alone
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.
Read the detailed description
A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.
- Conditions
- Anal Fistula
- Being tested
- Anal Fistula Plug, Endorectal Advancement Flap
- Keywords
- fistula in ano, anal fistula, recurrence, costs
- Medical subject headings
- Rectal Fistula, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal Fistula PlugProcedure or surgery
Also called Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
Endorectal Advancement FlapProcedure or surgery
Also called Advancement Mucosa Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
| Study group | Role | What they receive |
|---|---|---|
| Recurrent anal fistula | Active comparator | Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap Receives: Procedure: Anal Fistula Plug; Procedure: Endorectal Advancement Flap |
| No recurrence of anal fistula | Active comparator | Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap Receives: Procedure: Anal Fistula Plug; Procedure: Endorectal Advancement Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal fistula recurrence rate
Measured: One year
Secondary outcomes (5)
Cost
In-hospital costs. Typically 1 to 3 days of hospitalization
Measured: 3 days
Complication rate
Classified according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 3 days
Length of hospital stay
Typically 1 to 3 days of hospitalization.
Measured: 3 days
Independent factors predicting fistula recurrence
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
Measured: One year
Independent factors predicting higher costs
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMay 2007
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 ZurichThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver M Fisher, MD, Principal investigator, University of ZurichAntonio Nocito, MD, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931371
- Sponsor's protocol ID
- AFPERAF
- Other IDs
- KEK-ZH-Nr. 2013-XYZ
- Acronym
- AFPERAF
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6.
PubMed 19733880Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
- ClinicalTrials.gov ID
- NCT01931371
- Acronym / sponsor ID
- AFPERAF / AFPERAF
- Conditions
- Anal Fistula
- Keywords
- fistula in ano, anal fistula, recurrence, costs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 29 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 purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.
Detailed description
A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent anal fistula | Active comparator | Procedure: Anal Fistula Plug, Procedure: Endorectal Advancement FlapPatients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap |
| No recurrence of anal fistula | Active comparator | Procedure: Anal Fistula Plug, Procedure: Endorectal Advancement FlapPatients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18 years of age or more)
- Single anal fistula
- Surgically treated with anal fistula plug or endorectal advancement flap
Key exclusion criteria (3 listed)
- Children or adolescents
- Pregnancy
- Patients treated with setons alone
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 PlugAlso: Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug | Procedure or surgery | No recurrence of anal fistula, Recurrent anal fistula |
| Endorectal Advancement FlapAlso: Advancement Mucosa FlapSurgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap | Procedure or surgery | No recurrence of anal fistula, Recurrent anal fistula |
Primary outcome
Anal fistula recurrence rate
Time frame: One year
5 secondary outcomes
Cost
Time frame: 3 days
Complication rate
Time frame: 3 days
Length of hospital stay
Time frame: 3 days
Independent factors predicting fistula recurrence
Time frame: One year
Independent factors predicting higher costs
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
- Background: PubMed 19733880Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6.
- Background: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
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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.
Oliver M Fisher, MD principal investigator
University of Zurich
Antonio Nocito, MD study chair
University of Zurich
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 Plug and Endorectal Advancement Flap in people with Anal Fistula, run by University of Zurich at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 2013. 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 Switzerland. 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?
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?
Anal fistula recurrence rate (time frame: One 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 NCT01931371, which also lists 2 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 29 Aug 2013.