Surgical Treatment of High Perianal Fistulas

Anal Fistula Clinical Trial

— LIFTRAF  

Official title:

Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01997645
• Other study ID #: FN HK CP 2013
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2013
• Last updated: November 22, 2013
• Start date: November 2013

Study information

• Verified date: November 2013
• Source: University Hospital Hradec Kralove
• Contact: Július Örhalmi, MD
• Phone: +420606506391
• Email: orhalmi[@]volny.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.

Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.

Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).

The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years old or older

• Diagnosis of simple intersphincteric or transsphincteric fistula

• Patients able to comply with the study protocol as per investigator criteria

• Signed and dated informed consent by the patient

• Absence of any exclusion criteria

Exclusion Criteria:

• Recurrent anal fistula

• Suprasphincteric, low subcutaneous fistula

• Multiple fistulas

• Posttraumatic fistula

• Perianal hidradenitis

• Fistula arises from other than cryptoglandular origin

• Previous anal surgery except of abscess

• Inflammatory Bowel Disease

• History of fecal incontinence

• Rectal prolapse

• Malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment

• HIV infection

• Pregnancy

• Participation in another clinical trial less than one month prior to enrolment, or involvement in another trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• LIFT

• RAF

Locations

Country	Name	City	State
Czech Republic	Department of Surgery, Charles University, Faculty of Medicine and University Hospital	Hradec Kralove
Czech Republic	Departement of Surgery, District Hospital	Novy Jicin
Czech Republic	Departement of Surgery, Military University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czech Republic, 

References & Publications (10)

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

García-Aguilar J, Belmonte C, Wong DW, Goldberg SM, Madoff RD. Cutting seton versus two-stage seton fistulotomy in the surgical management of high anal fistula. Br J Surg. 1998 Feb;85(2):243-5. — View Citation

Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review. — View Citation

Malik AI, Nelson RL. Surgical management of anal fistulae: a systematic review. Colorectal Dis. 2008 Jun;10(5):420-30. doi: 10.1111/j.1463-1318.2008.01483.x. Review. — View Citation

Marks CG, Ritchie JK. Anal fistulas at St Mark's Hospital. Br J Surg. 1977 Feb;64(2):84-91. — View Citation

Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg. 1976 Jan;63(1):1-12. — View Citation

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. — View Citation

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. Review. — View Citation

Soltani A, Kaiser AM. Endorectal advancement flap for cryptoglandular or Crohn's fistula-in-ano. Dis Colon Rectum. 2010 Apr;53(4):486-95. doi: 10.1007/DCR.0b013e3181ce8b01. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Fistula recurrence will be defined according to AGA (American Gastroenterological Association) criteria as a purulent secretion from external fistula opening followed the compression.; Fistula recurrence will be confirmed by evaluation under anesthesia (followed by drainage).	One year	No
Secondary	Postoperative pain	Postoperative pain will be assessed 4 times per day during the first 2 postoperative days (VAS - visual analogue scale), after that 3 times per day over next 14 days (patient's diary).	14 days	No
Secondary	Pre- and postoperative continence	Pre- and postoperative continence will be evaluated with Wexner score.	One year	No
Secondary	Postoperative morbidity	Will be evaluated according to Clavien-Dindo classification.	One month	No
Secondary	Quality of life	For quality of life evaluation SF-36 questionnaire will be used.	One year	No