Endoscopic Treatment of Complex Anal Fistulas

NCT02585167 | Terminated DMC

• 1 other identifier: S-20150053
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Fistula

Keywords

VAAFT; anal fistula; sphincter reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• changes in quality of life score

  baseline and 6 months

• changes in fecal incontinence score

  baseline and 6 months

• changes in manometric study

  baseline and 6 months

Study Arms (2)

Operation

ACTIVE COMPARATOR

the fistula will be excised after dividing the sphincter and primary reconstruction .

Procedure: operation

VAAFT

EXPERIMENTAL

the fistula tract will be visualized by scope, closing the internal opening with absorbable sutures.

Device: VAAFT

Interventions

operation PROCEDURE

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.

Also known as: Fistulectomy and primary sphincter reconstruction

Operation

VAAFT DEVICE

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.

VAAFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Crohns fistulas
• Signs of suppuration or/and branching.
• Malignancy within 5 yrs.
• Previous radiotherapy of the abdomen and pelvis.
• Current Immune- suppressive treatment.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (27)

• 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.

  PMID: 9068549 BACKGROUND

• Nicholls J. Anal fistula. Colorectal Dis. 2012 May;14(5):535. doi: 10.1111/j.1463-1318.2012.03025.x. No abstract available.

  PMID: 22469475 BACKGROUND

• 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):C5088.

  PMID: 26050835 BACKGROUND

• 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. No abstract available.

  PMID: 22067173 BACKGROUND

• Hvas 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.

  PMID: 21975159 BACKGROUND

• Nicholls RJ. Fistula in ano: an overview. Acta Chir Iugosl. 2012;59(2):9-13. doi: 10.2298/aci1202009n.

  PMID: 23373352 BACKGROUND

• Christiansen J, Moesgaard FA. [Treatment of anal fistulas]. Ugeskr Laeger. 2002 Sep 23;164(39):4519-21. No abstract available. Danish.

  PMID: 12380393 BACKGROUND

• 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.

  PMID: 19486093 BACKGROUND

• 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.

  PMID: 23303152 BACKGROUND

• Roig 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.

  PMID: 19604292 BACKGROUND

• Perez 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.

  PMID: 16769272 BACKGROUND

• Roig, 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.

  PMID: 23577759 BACKGROUND

• 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.

  PMID: 19459524 BACKGROUND

• 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.

  PMID: 22706126 BACKGROUND

• 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.

  PMID: 22002535 BACKGROUND

• 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.

  PMID: 24509459 BACKGROUND

• 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.

  PMID: 23179892 BACKGROUND

• 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. No abstract available.

  PMID: 22016156 BACKGROUND

• 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. doi: 10.1007/s00384-005-0060-y. Epub 2005 Nov 30.

  PMID: 16317550 BACKGROUND

• Grucela A, Gurland B, Kiran RP. Functional outcomes and quality of life after anorectal surgery. Am Surg. 2012 Sep;78(9):952-6.

  PMID: 22964203 BACKGROUND

• 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. doi: 10.1007/s10350-007-9006-5.

  PMID: 17680311 BACKGROUND

• Riss S, Schwameis K, Mittlbock 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.

  PMID: 22956209 BACKGROUND

• Roig JV, Jordan J, Garcia-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.

  PMID: 19617761 BACKGROUND

• Ha HT, Fleshman JW, Smith M, Read TE, Kodner IJ, Birnbaum EH. Manometric squeeze pressure difference parallels functional outcome after overlapping sphincter reconstruction. Dis Colon Rectum. 2001 May;44(5):655-60. doi: 10.1007/BF02234561.

  PMID: 11357023 BACKGROUND

• 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. doi: 10.1046/j.1365-2168.1998.00958.x.

  PMID: 9876082 BACKGROUND

• Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg. 1976 Jan;63(1):1-12. doi: 10.1002/bjs.1800630102.

  PMID: 1267867 BACKGROUND

• Sorensen KM, Moller S, Qvist N. Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study. BJS Open. 2021 Sep 6;5(5):zrab097. doi: 10.1093/bjsopen/zrab097.

  PMID: 34611700 DERIVED

Related Links

• OPEN homepage

MeSH Terms

Conditions

Rectal Fistula

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: læge

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

DK (1)