Anal FistulaVAAFTNCT02585167
Endoscopic Treatment of Complex Anal Fistulas
A study testing operation and VAAFT in people with Anal Fistula, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure. 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?
- operation and VAAFT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complex transsphincteric anal fistulas >18 yrs old.
Who cannot join
- Crohns fistulas
- Signs of suppuration or/and branching.
- Malignancy within 5 yrs.
- Previous radiotherapy of the abdomen and pelvis.
- Current Immune- suppressive treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study
This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.
Read the detailed description
The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.
- Conditions
- Anal Fistula
- Being tested
- operation, VAAFT
- Keywords
- VAAFT, anal fistula, sphincter reconstruction
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operationProcedure or surgery
Also called Fistulectomy and primary sphincter reconstruction
the fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage.
VAAFTDevice
Karl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage.
| Study group | Role | What they receive |
|---|---|---|
| Operation | Active comparator | the fistula will be excised after dividing the sphincter and primary reconstruction
. Receives: Procedure: operation |
| VAAFT | Experimental | the fistula tract will be visualized by scope, closing the internal opening with absorbable sutures. Receives: Device: VAAFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of perianal fistula
A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
Measured: 6 months
Secondary outcomes (3)
changes in quality of life score
A comparison on changes in quality of life, using The Short Form (36) Health Survey in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
Measured: baseline and 6 months
changes in fecal incontinence score
A comparison on changes in Wexner score in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
Measured: baseline and 6 months
changes in manometric study
A comparison on changes in manometric study(including maximum resting pressure, maximum squeeze pressure) in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionMay 2021
- Study completionMay 2021
Why it stopped: The significantly higher recurrence rate in the intervention group led to a serious ethical consideration of a premature closing of the study which was decided due to safety and benefit concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)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 DenmarkThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Karam Matlub Sørensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585167
- Sponsor's protocol ID
- S-20150053
- Acronym
- VAAFT
- Status last verified
- May 2021
- First submitted
- 20 Oct 2015
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barwood N, Clarke G, Levitt S, Levitt M. Fistula-in-ano: a prospective study of 107 patients. Aust N Z J Surg. 1997 Feb-Mar;67(2-3):98-102. doi: 10.1111/j.1445-2197.1997.tb01911.x.
PubMed 9068549Nicholls J. Anal fistula. Colorectal Dis. 2012 May;14(5):535. doi: 10.1111/j.1463-1318.2012.03025.x. No abstract available.
PubMed 22469475Lundby L, Hagen K, Christensen P, Buntzen S, Thorlacius-Ussing O, Andersen J, Krupa M, Qvist N. Treatment of non-IBD anal fistula. Dan Med J. 2015 May;62(5):C5088.
PubMed 26050835Steele SR, Kumar R, Feingold DL, Rafferty JL, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of perianal abscess and fistula-in-ano. Dis Colon Rectum. 2011 Dec;54(12):1465-74. doi: 10.1097/DCR.0b013e31823122b3. No abstract available.
PubMed 22067173Hvas CL, Dahlerup JF, Jacobsen BA, Ljungmann K, Qvist N, Staun M, Tottrup A. Diagnosis and treatment of fistulising Crohn's disease. Dan Med Bull. 2011 Oct;58(10):C4338.
PubMed 21975159Nicholls RJ. Fistula in ano: an overview. Acta Chir Iugosl. 2012;59(2):9-13. doi: 10.2298/aci1202009n.
PubMed 23373352Christiansen J, Moesgaard FA. [Treatment of anal fistulas]. Ugeskr Laeger. 2002 Sep 23;164(39):4519-21. No abstract available. Danish.
PubMed 12380393Bokhari S, Lindsey I. Incontinence following sphincter division for treatment of anal fistula. Colorectal Dis. 2010 Jul;12(7 Online):e135-9. doi: 10.1111/j.1463-1318.2009.01872.x. Epub 2009 Apr 10.
PubMed 19486093Ratto C, Litta F, Parello A, Zaccone G, Donisi L, De Simone V. Fistulotomy with end-to-end primary sphincteroplasty for anal fistula: results from a prospective study. Dis Colon Rectum. 2013 Feb;56(2):226-33. doi: 10.1097/DCR.0b013e31827aab72.
PubMed 23303152Roig JV, Garcia-Armengol J, Jordan JC, Moro D, Garcia-Granero E, Alos R. Fistulectomy and sphincteric reconstruction for complex cryptoglandular fistulas. Colorectal Dis. 2010 Jul;12(7 Online):e145-52. doi: 10.1111/j.1463-1318.2009.02002.x. Epub 2009 Jul 9.
PubMed 19604292Perez F, Arroyo A, Serrano P, Sanchez A, Candela F, Perez MT, Calpena R. Randomized clinical and manometric study of advancement flap versus fistulotomy with sphincter reconstruction in the management of complex fistula-in-ano. Am J Surg. 2006 Jul;192(1):34-40. doi: 10.1016/j.amjsurg.2006.01.028.
PubMed 16769272Roig, Garcia-Armengol, Jordan, Alos, Solana. Immediate reconstruction of the anal sphincter after fistulectomy in the management of complex anal fistulas. Colorectal Dis. 1999 May;1(3):137-40. doi: 10.1046/j.1463-1318.1999.00021.x.
PubMed 23577759Jivapaisarnpong P. Core out fistulectomy, anal sphincter reconstruction and primary repair of internal opening in the treatment of complex anal fistula. J Med Assoc Thai. 2009 May;92(5):638-42.
PubMed 19459524Tobisch A, Stelzner S, Hellmich G, Jackisch T, Witzigmann H. Total fistulectomy with simple closure of the internal opening in the management of complex cryptoglandular fistulas: long-term results and functional outcome. Dis Colon Rectum. 2012 Jul;55(7):750-5. doi: 10.1097/DCR.0b013e3182569b29.
PubMed 22706126Meinero P, Mori L. Video-assisted anal fistula treatment (VAAFT): a novel sphincter-saving procedure for treating complex anal fistulas. Tech Coloproctol. 2011 Dec;15(4):417-22. doi: 10.1007/s10151-011-0769-2. Epub 2011 Oct 15.
PubMed 22002535
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02585167
- Acronym / sponsor ID
- VAAFT / S-20150053
- Conditions
- Anal Fistula
- Keywords
- VAAFT, anal fistula, sphincter reconstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The significantly higher recurrence rate in the intervention group led to a serious ethical consideration of a premature closing of the study which was decided due to safety and benefit concerns
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 23 Oct 2015 (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.
This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.
Detailed description
The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operation | Active comparator | Procedure: operationthe fistula will be excised after dividing the sphincter and primary reconstruction . |
| VAAFT | Experimental | Device: VAAFTthe fistula tract will be visualized by scope, closing the internal opening with absorbable sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with complex transsphincteric anal fistulas >18 yrs old.
Key exclusion criteria (5 listed)
- Crohns fistulas
- Signs of suppuration or/and branching.
- Malignancy within 5 yrs.
- Previous radiotherapy of the abdomen and pelvis.
- Current Immune- suppressive treatment.
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 |
|---|---|---|
| operationAlso: Fistulectomy and primary sphincter reconstructionthe fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage. | Procedure or surgery | Operation |
| VAAFTKarl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage. | Device | VAAFT |
Primary outcome
The recurrence rate of perianal fistula
Time frame: 6 months
A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
3 secondary outcomes
changes in quality of life score
Time frame: baseline and 6 months
changes in fecal incontinence score
Time frame: baseline and 6 months
changes in manometric study
Time frame: baseline and 6 months
Results and safety
The study was stopped early (reason given: The significantly higher recurrence rate in the intervention group led to a serious ethical consideration of a premature closing of the study which was decided due to safety and benefit concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Background: PubMed 9068549Barwood N, Clarke G, Levitt S, Levitt M. Fistula-in-ano: a prospective study of 107 patients. Aust N Z J Surg. 1997 Feb-Mar;67(2-3):98-102. doi: 10.1111/j.1445-2197.1997.tb01911.x.
- Background: PubMed 22469475Nicholls J. Anal fistula. Colorectal Dis. 2012 May;14(5):535. doi: 10.1111/j.1463-1318.2012.03025.x. No abstract available.
- Background: PubMed 26050835Lundby L, Hagen K, Christensen P, Buntzen S, Thorlacius-Ussing O, Andersen J, Krupa M, Qvist N. Treatment of non-IBD anal fistula. Dan Med J. 2015 May;62(5):C5088.
- Background: PubMed 22067173Steele SR, Kumar R, Feingold DL, Rafferty JL, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of perianal abscess and fistula-in-ano. Dis Colon Rectum. 2011 Dec;54(12):1465-74. doi: 10.1097/DCR.0b013e31823122b3. No abstract available.
- Background: PubMed 21975159Hvas CL, Dahlerup JF, Jacobsen BA, Ljungmann K, Qvist N, Staun M, Tottrup A. Diagnosis and treatment of fistulising Crohn's disease. Dan Med Bull. 2011 Oct;58(10):C4338.
- Background: PubMed 23373352Nicholls RJ. Fistula in ano: an overview. Acta Chir Iugosl. 2012;59(2):9-13. doi: 10.2298/aci1202009n.
- Background: PubMed 12380393Christiansen J, Moesgaard FA. [Treatment of anal fistulas]. Ugeskr Laeger. 2002 Sep 23;164(39):4519-21. No abstract available. Danish.
- Background: PubMed 19486093Bokhari S, Lindsey I. Incontinence following sphincter division for treatment of anal fistula. Colorectal Dis. 2010 Jul;12(7 Online):e135-9. doi: 10.1111/j.1463-1318.2009.01872.x. Epub 2009 Apr 10.
- Background: PubMed 23303152Ratto C, Litta F, Parello A, Zaccone G, Donisi L, De Simone V. Fistulotomy with end-to-end primary sphincteroplasty for anal fistula: results from a prospective study. Dis Colon Rectum. 2013 Feb;56(2):226-33. doi: 10.1097/DCR.0b013e31827aab72.
- Background: PubMed 19604292Roig JV, Garcia-Armengol J, Jordan JC, Moro D, Garcia-Granero E, Alos R. Fistulectomy and sphincteric reconstruction for complex cryptoglandular fistulas. Colorectal Dis. 2010 Jul;12(7 Online):e145-52. doi: 10.1111/j.1463-1318.2009.02002.x. Epub 2009 Jul 9.
- Background: PubMed 16769272Perez F, Arroyo A, Serrano P, Sanchez A, Candela F, Perez MT, Calpena R. Randomized clinical and manometric study of advancement flap versus fistulotomy with sphincter reconstruction in the management of complex fistula-in-ano. Am J Surg. 2006 Jul;192(1):34-40. doi: 10.1016/j.amjsurg.2006.01.028.
- Background: PubMed 23577759Roig, Garcia-Armengol, Jordan, Alos, Solana. Immediate reconstruction of the anal sphincter after fistulectomy in the management of complex anal fistulas. Colorectal Dis. 1999 May;1(3):137-40. doi: 10.1046/j.1463-1318.1999.00021.x.
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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 operation and VAAFT in people with Anal Fistula, run by University of Southern Denmark at 1 site in Denmark.
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 5 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 14 May 2021. 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 Denmark. 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 stopped early (reason given: The significantly higher recurrence rate in the intervention group led to a serious ethical consideration of a premature closing of the study which was decided due to safety and benefit concerns). 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?
The recurrence rate of perianal fistula (time frame: 6 months). 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 NCT02585167, which also lists 27 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 14 May 2021.