Endoscopic Treatment of Complex Anal Fistulas

Anal Fistula Clinical Trial

— VAAFT  

Official title:

Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02585167
• Other study ID #: S-20150053
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with complex transsphincteric anal fistulas >18 yrs old.

Exclusion Criteria:

• Crohns fistulas

• Signs of suppuration or/and branching.

• Malignancy within 5 yrs.

• Previous radiotherapy of the abdomen and pelvis.

• Current Immune- suppressive treatment.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• operation
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.

Device:
• VAAFT
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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (26)

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Bokhari 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. — View Citation

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Hvas CL, Dahlerup JF, Jacobsen BA, Ljungmann K, Qvist N, Staun M, Tøttrup A. Diagnosis and treatment of fistulising Crohn's disease. Dan Med Bull. 2011 Oct;58(10):C4338. Review. — View Citation

Jivapaisarnpong 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. — View Citation

Kasparek MS, Glatzle J, Temeltcheva T, Mueller MH, Koenigsrainer A, Kreis ME. Long-term quality of life in patients with Crohn's disease and perianal fistulas: influence of fecal diversion. Dis Colon Rectum. 2007 Dec;50(12):2067-74. — View Citation

Lundby 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). pii: C5088. — View Citation

Meinero P, Mori L, Gasloli G. Video-assisted anal fistula treatment: a new concept of treating anal fistulas. Dis Colon Rectum. 2014 Mar;57(3):354-9. doi: 10.1097/DCR.0000000000000082. — View Citation

Meinero 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. Erratum in: Tech Coloproctol. 2012 Feb;16(1):111. — View Citation

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Perez F, Arroyo A, Serrano P, Sánchez 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. — View Citation

Quah HM, Tang CL, Eu KW, Chan SY, Samuel M. Meta-analysis of randomized clinical trials comparing drainage alone vs primary sphincter-cutting procedures for anorectal abscess-fistula. Int J Colorectal Dis. 2006 Sep;21(6):602-9. Epub 2005 Nov 30. Review. — View Citation

Ratto 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. — View Citation

Riss S, Schwameis K, Mittlböck M, Pones M, Vogelsang H, Reinisch W, Riedl M, Stift A. Sexual function and quality of life after surgical treatment for anal fistulas in Crohn's disease. Tech Coloproctol. 2013 Feb;17(1):89-94. doi: 10.1007/s10151-012-0890-x. Epub 2012 Sep 6. — View Citation

Roig JV, García-Armengol J, Jordán JC, Moro D, García-Granero E, Alós 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. — View Citation

Roig JV, Jordán J, García-Armengol J, Esclapez P, Solana A. Changes in anorectal morphologic and functional parameters after fistula-in-ano surgery. Dis Colon Rectum. 2009 Aug;52(8):1462-9. doi: 10.1007/DCR.0b013e3181a80e24. — View Citation

Roig, Garcia-Armengol, Jordán, 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. — View Citation

Sailer M, Bussen D, Debus ES, Fuchs KH, Thiede A. Quality of life in patients with benign anorectal disorders. Br J Surg. 1998 Dec;85(12):1716-9. — View Citation

Schwandner O. Video-assisted anal fistula treatment (VAAFT) combined with advancement flap repair in Crohn's disease. Tech Coloproctol. 2013 Apr;17(2):221-5. doi: 10.1007/s10151-012-0921-7. Epub 2012 Nov 23. — View Citation

Steele 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. — View Citation

Tobisch 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. — View Citation

Zbar AP. "Video-assisted anal fistula treatment (VAAFT): a novel sphincter-saving procedure to repair complex anal fistulas" by Piercarlo Meinero and Lorenzo Mori. Tech Coloproctol. 2011 Dec;15(4):423-4. doi: 10.1007/s10151-011-0771-8. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	baseline and 6 months
Secondary	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.	baseline and 6 months
Secondary	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.	baseline and 6 months

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