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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal advanced mucosal flap | Active Comparator | 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. |
|
| Ligation of intersphincteric fistula tract | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFT | Procedure |
| ||
| RAF |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pre- and postoperative continence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Július Örhalmi, MD | Contact | +420606506391 | orhalmi@volny.cz |
| Name | Affiliation | Role |
|---|---|---|
| Július Örhalmi, MD | University Hospital Hradec Kralove | Principal Investigator |
| Zuzana Šerclová, MD | Central MIlitary Hospital Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Charles University, Faculty of Medicine and University Hospital | Recruiting | Hradec Králové | 50005 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 890252 | Background | 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. | |
| 1267867 | Background | 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. |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
Pre- and postoperative continence will be evaluated with Wexner score.
| One year |
| Postoperative morbidity | Will be evaluated according to Clavien-Dindo classification. | One month |
| Quality of life | For quality of life evaluation SF-36 questionnaire will be used. | One year |
| Karel Klos, MD |
| District Hospital Nový Jičín |
| Principal Investigator |
| Departement of Surgery, District Hospital | Recruiting | Nový Jičín | 74101 | Czechia |
|
| Departement of Surgery, Military University Hospital | Recruiting | Prague | 16902 | Czechia |
|
| 18479308 | Background | 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. |
| 9501826 | Background | 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. |
| 20305451 | Background | 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. |
| 17427539 | Background | 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. |
| 23551996 | Background | 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. |
| 14598268 | Background | 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. |
| 8416784 | Background | Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307. |
| 15273542 | Background | 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. |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |