Surgical Treatment of High Perianal Fistulas

Study Overview
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Brief Summary
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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.

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

Conditions
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Anal Fistula, Rectal Fistula

Intervention / Treatment
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* Procedure: LIFT
* Procedure: RAF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectal advanced mucosal flap<br>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. | Procedure: RAF<br> <br> |
| Active Comparator: Ligation of intersphincteric fistula tract<br>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. | Procedure: LIFT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal fistula, Rectal fistula, Intersphincteric fistula, Perianal fistula