Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula

NCT05263661 | Unknown Phase 3 DMC

• 2 other identifiers: LIFTRAF-RCTJBB1
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Rectal advancement flap (RAF) is currently considered the gold standard in the treatment of complex anal fistula (CAF). Clinical trials are a priority given the few consistent results available with level 1 evidence. We compare the results of two conservative sphincter techniques: ligation of intersphincteric fistula tract (LIFT) versus RAF. Material and Method: A controlled, randomised clinical trial is conducted in patients operated between 2013 and 2016 in Hospital General Universitario Reina Sofia, Murcia, Spain. The primary objective was to evaluate relapse at 12 months of follow-up, and the secondary objectives were post-op anal continence (Wexner), post-operative complications (haematoma, infection of surgical site, suture dehiscence), duration of surgery and hospitalisation. Post-operative controls 1, 3, 6 and 12 months after surgery.

Conditions

Anal Fistula

Keywords

anal fistula, lift, advancement flap, recurrence

Outcome Measures

Primary Outcomes (1)

• Curation

  Proportion of subjects in each treatment group without fistula recurrence after surgery

  1 year

Secondary Outcomes (4)

• Functionality

  1 year

• Security

  1 month

• Time of recurrence

  10 years

• Time of surgery

  1 day

Study Arms (2)

LIFT

EXPERIMENTAL

ligation of interesphincteric fistula tract

Procedure: LIFT

FLAP

ACTIVE COMPARATOR

Rectal advancement flap

Procedure: FLAP

Interventions

LIFT PROCEDURE

Ligation of fistula tract between external and internal sphincter

Also known as: ligation of interesphincteric fistula tract

LIFT

FLAP PROCEDURE

Creation of a partial wall rectal flap to close internal opening of fistula tract

Also known as: Rectal advancement flap

FLAP

Eligibility Criteria

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

You may qualify if:

• patient diagnosed with transsphincteric (medium or high) or suprasphincteric cryptoglandular anal fistula
• with no abscess at the time of surgery
• who agreed to participate and signed the informed consent form
• capable transsphincteric understanding and following study instructions

You may not qualify if:

• diagnosed with, or with a suspected diagnosis of, Crohn's disease
• diagnosed with, or with a suspected diagnosis of, malignant anal tumour
• diagnosed with, or with a suspected diagnosis of,tuberculosis or suppurative hidradenitis
• a history of radiotherapy of the ano-perineal region
• language difficulties that prevent comprehension of the study
• refusal to participate

Sponsors & Collaborators

• Hospital General Universitario Reina Sofía de Murcia: lead

Related Publications (30)

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• 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.

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• 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.

  PMID: 25566951 RESULT

• 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.

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• 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.

  PMID: 26929751 RESULT

• 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.

  PMID: 25761803 RESULT

• 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.

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  PMID: 14598268 RESULT

• 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.

  PMID: 26847796 RESULT

• 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.

  PMID: 22067182 RESULT

• 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.

  PMID: 25487858 RESULT

• 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.

  PMID: 17427539 RESULT

• 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.

  PMID: 8330181 RESULT

• 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.

  PMID: 20010349 RESULT

• 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.

  PMID: 28247060 RESULT

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  PMID: 19591140 RESULT

• 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.

  PMID: 28489253 RESULT

• 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.

  PMID: 28891850 RESULT

• 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.

  PMID: 28271064 RESULT

• 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.

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• 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.

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  PMID: 24187455 RESULT

• 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.

  PMID: 30178915 RESULT

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MeSH Terms

Conditions

Rectal Fistula; Recurrence

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; Disease Attributes; Pathologic Processes

Study Officials

• Jorge Alejandro Benavides Buleje, PhD

  Hospital General Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A controlled, randomised clinical trial

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share