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Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula (LIFTRAF-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05263661

Recruitment Status : Unknown

Verified February 2022 by Jorge Alejandro Benavides Buleje, Hospital General Universitario Reina Sofía de Murcia.
Recruitment status was: Active, not recruiting

First Posted : March 2, 2022

Last Update Posted : March 2, 2022

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Jorge Alejandro Benavides Buleje, Hospital General Universitario Reina Sofía de Murcia

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Unknown
Actual Primary Completion Date :	January 1, 2014
Estimated Study Completion Date :	January 1, 2023

Publications of Results:

Bleier JI, Moloo H. Current management of cryptoglandular fistula-in-ano. World J Gastroenterol. 2011 Jul 28;17(28):3286-91. doi: 10.3748/wjg.v17.i28.3286.

Cadeddu F, Salis F, Lisi G, Ciangola I, Milito G. Complex anal fistula remains a challenge for colorectal surgeon. Int J Colorectal Dis. 2015 May;30(5):595-603. doi: 10.1007/s00384-014-2104-7. Epub 2015 Jan 9.

Narang SK, Keogh K, Alam NN, Pathak S, Daniels IR, Smart NJ. A systematic review of new treatments for cryptoglandular fistula in ano. Surgeon. 2017 Feb;15(1):30-39. doi: 10.1016/j.surge.2016.02.002. Epub 2016 Mar 15.

Bubbers EJ, Cologne KG. Management of Complex Anal Fistulas. Clin Colon Rectal Surg. 2016 Mar;29(1):43-9. doi: 10.1055/s-0035-1570392.

Phillips J, Lees N, Arnall F. Current management of fistula-in-ano. Br J Hosp Med (Lond). 2015 Mar;76(3):142, 144-7. doi: 10.12968/hmed.2015.76.3.142.

Jacob TJ, Perakath B, Keighley MR. Surgical intervention for anorectal fistula. Cochrane Database Syst Rev. 2010 May 12;(5):CD006319. doi: 10.1002/14651858.CD006319.pub2.

Sandborn WJ, Fazio VW, Feagan BG, Hanauer SB; American Gastroenterological Association Clinical Practice Committee. AGA technical review on perianal Crohn's disease. Gastroenterology. 2003 Nov;125(5):1508-30. doi: 10.1016/j.gastro.2003.08.025. No abstract available.

de Groof EJ, Cabral VN, Buskens CJ, Morton DG, Hahnloser D, Bemelman WA; research committee of the European Society of Coloproctology. Systematic review of evidence and consensus on perianal fistula: an analysis of national and international guidelines. Colorectal Dis. 2016 Apr;18(4):O119-34. doi: 10.1111/codi.13286.

Jarrar A, Church J. Advancement flap repair: a good option for complex anorectal fistulas. Dis Colon Rectum. 2011 Dec;54(12):1537-41. doi: 10.1097/DCR.0b013e31822d7ddd.

Gottgens KW, Smeets RR, Stassen LP, Beets G, Breukink SO. Systematic review and meta-analysis of surgical interventions for high cryptoglandular perianal fistula. Int J Colorectal Dis. 2015 May;30(5):583-93. doi: 10.1007/s00384-014-2091-8. Epub 2014 Dec 10.

Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva K. Total anal sphincter saving technique for fistula-in-ano; the ligation of intersphincteric fistula tract. J Med Assoc Thai. 2007 Mar;90(3):581-6.

Matos D, Lunniss PJ, Phillips RK. Total sphincter conservation in high fistula in ano: results of a new approach. Br J Surg. 1993 Jun;80(6):802-4. doi: 10.1002/bjs.1800800651.

Bleier JI, Moloo H, Goldberg SM. Ligation of the intersphincteric fistula tract: an effective new technique for complex fistulas. Dis Colon Rectum. 2010 Jan;53(1):43-6. doi: 10.1007/DCR.0b013e3181bb869f.

Balciscueta Z, Uribe N, Balciscueta I, Andreu-Ballester JC, Garcia-Granero E. Rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 May;32(5):599-609. doi: 10.1007/s00384-017-2779-7. Epub 2017 Feb 28.

Garg P. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano (Br J Surg 2009; 96: 608-612). Br J Surg. 2009 Aug;96(8):958-9; author reply 959. doi: 10.1002/bjs.6772. No abstract available.

Bondi J, Avdagic J, Karlbom U, Hallbook O, Kalman D, Saltyte Benth J, Naimy N, Oresland T. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula. Br J Surg. 2017 Aug;104(9):1160-1166. doi: 10.1002/bjs.10549. Epub 2017 May 10.

Malakorn S, Sammour T, Khomvilai S, Chowchankit I, Gunarasa S, Kanjanasilp P, Thiptanakij C, Rojanasakul A. Ligation of Intersphincteric Fistula Tract for Fistula in Ano: Lessons Learned From a Decade of Experience. Dis Colon Rectum. 2017 Oct;60(10):1065-1070. doi: 10.1097/DCR.0000000000000880.

Xu Y, Tang W. Ligation of Intersphincteric Fistula Tract Is Suitable for Recurrent Anal Fistulas from Follow-Up of 16 Months. Biomed Res Int. 2017;2017:3152424. doi: 10.1155/2017/3152424. Epub 2017 Feb 8.

Mushaya C, Bartlett L, Schulze B, Ho YH. Ligation of intersphincteric fistula tract compared with advancement flap for complex anorectal fistulas requiring initial seton drainage. Am J Surg. 2012 Sep;204(3):283-9. doi: 10.1016/j.amjsurg.2011.10.025. Epub 2012 May 19.

Madbouly KM, El Shazly W, Abbas KS, Hussein AM. Ligation of intersphincteric fistula tract versus mucosal advancement flap in patients with high transsphincteric fistula-in-ano: a prospective randomized trial. Dis Colon Rectum. 2014 Oct;57(10):1202-8. doi: 10.1097/DCR.0000000000000194.

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.

Ye F, Tang C, Wang D, Zheng S. Early experience with the modificated approach of ligation of the intersphincteric fistula tract for high transsphincteric fistula. World J Surg. 2015 Apr;39(4):1059-65. doi: 10.1007/s00268-014-2888-1.

Sirikurnpiboon S, Awapittaya B, Jivapaisarnpong P. Ligation of intersphincteric fistula tract and its modification: Results from treatment of complex fistula. World J Gastrointest Surg. 2013 Apr 27;5(4):123-8. doi: 10.4240/wjgs.v5.i4.123.

Yassin NA, Hammond TM, Lunniss PJ, Phillips RK. Ligation of the intersphincteric fistula tract in the management of anal fistula. A systematic review. Colorectal Dis. 2013 May;15(5):527-35. doi: 10.1111/codi.12224.

Vergara-Fernandez O, Espino-Urbina LA. Ligation of intersphincteric fistula tract: what is the evidence in a review? World J Gastroenterol. 2013 Oct 28;19(40):6805-13. doi: 10.3748/wjg.v19.i40.6805.

Williams G, Williams A, Tozer P, Phillips R, Ahmad A, Jayne D, Maxwell-Armstrong C. The treatment of anal fistula: second ACPGBI Position Statement - 2018. Colorectal Dis. 2018 Jul;20 Suppl 3:5-31. doi: 10.1111/codi.14054.

Gecse KB, Bemelman W, Kamm MA, Stoker J, Khanna R, Ng SC, Panes J, van Assche G, Liu Z, Hart A, Levesque BG, D'Haens G; World Gastroenterology Organization, International Organisation for Inflammatory Bowel Diseases IOIBD, European Society of Coloproctology and Robarts Clinical Trials; World Gastroenterology Organization International Organisation for Inflammatory Bowel Diseases IOIBD European Society of Coloproctology and Robarts Clinical Trials. A global consensus on the classification, diagnosis and multidisciplinary treatment of perianal fistulising Crohn's disease. Gut. 2014 Sep;63(9):1381-92. doi: 10.1136/gutjnl-2013-306709. Epub 2014 Jun 20.

Other Publications:

Sahnan K, Askari A, Adegbola SO, Tozer PJ, Phillips RKS, Hart A, Faiz OD. Natural history of anorectal sepsis. Br J Surg. 2017 Dec;104(13):1857-1865. doi: 10.1002/bjs.10614. Epub 2017 Aug 31.

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.

Sneider EB, Maykel JA. Diagnosis and management of symptomatic hemorrhoids. Surg Clin North Am. 2010 Feb;90(1):17-32, Table of Contents. doi: 10.1016/j.suc.2009.10.005.