Clinical trial NCT01997645: Surgical Treatment of High Perianal Fistulas
Official title: Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Rectal Fistula
Keywords: Anal fistula
Rectal fistula
Intersphincteric fistula
Perianal fistula
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence rate
timeFrame: One year
Secondary outcomes:
measure: Postoperative pain
timeFrame: 14 days
measure: Pre- and postoperative continence
timeFrame: One year
measure: Postoperative morbidity
timeFrame: One month
measure: Quality of life
timeFrame: One year
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Department of Surgery, Charles University, Faculty of Medicine and University Hospital
city: Novy Jicin
country: Czech Republic
facility: Departement of Surgery, District Hospital
city: Prague
country: Czech Republic
facility: Departement of Surgery, Military University Hospital
Study officials:
affiliation: University Hospital Hradec Kralove
name: Július Örhalmi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central MIlitary Hospital Prague
name: Zuzana Šerclová, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: District Hospital Nový Jičín
name: Karel Klos, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
citation: Garcia-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. doi: 10.1046/j.1365-2168.1998.02877.x.
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.
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.
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.
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. doi: 10.1016/j.gastro.2003.08.025. No abstract available.
citation: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
citation: 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. doi: 10.1097/01.sla.0000133083.54934.ae.