Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2013-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rectal advanced mucosal flap
Procedure will be performed in general anesthesia without mechanical bowel preparation. Antibiotic prophylaxis (Metronidazole 1g) will be applied intravenously 60 minutes prior the surgery.
In RAF procedure, internal opening will identified and after infiltration with saline-adrenalin solution (1/100000) the mucosal flap will be mobilized proximally. The external tract and internal opening will be excised and the defect will be sutured. After that, the flap will be advanced from both sides with absorbable suture and overlapped over the internal opening. External openings will be left open.
RAF
Ligation of intersphincteric fistula tract
Procedure will be performed in general anesthesia without mechanical bowel preparation. Antibiotic prophylaxis (Metronidazole 1g) will be applied intravenously 60 minutes prior the surgery.
Before LIFT procedure the fistula tract will be identified with small probe. The intersphincteric space will be reached by dissection from small (2-4cm) incision. The fistula tract will be divided and ligated on both sides with Polydioxanone (PDS) suture. The external and internal openings will be left open to drain.
LIFT
Interventions
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LIFT
RAF
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital Hradec Kralove
OTHER
Responsible Party
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Otakar Sotona
MD
Principal Investigators
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Július Örhalmi, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Hradec Kralove
Zuzana Šerclová, MD
Role: PRINCIPAL_INVESTIGATOR
Central MIlitary Hospital Prague
Karel Klos, MD
Role: PRINCIPAL_INVESTIGATOR
District Hospital Nový Jičín
Locations
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Department of Surgery, Charles University, Faculty of Medicine and University Hospital
Hradec Králové, , Czechia
Departement of Surgery, District Hospital
Nový Jičín, , Czechia
Departement of Surgery, Military University Hospital
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Július Örhalmi, MD
Role: primary
Karel Klos, MD
Role: primary
Zuzana Šerclová, MD
Role: primary
References
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Marks CG, Ritchie JK. Anal fistulas at St Mark's Hospital. Br J Surg. 1977 Feb;64(2):84-91. doi: 10.1002/bjs.1800640203.
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.
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.
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.
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.
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.
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.
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.
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
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.
Other Identifiers
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FN HK CP 2013
Identifier Type: -
Identifier Source: org_study_id