Surgical Treatment of High Perianal Fistulas (LIFTRAF)

University Hospital Hradec Kralove

Status: Unknown

Conditions: Rectal Fistula; Anal Fistula

Treatments: Procedure: LIFT; Procedure: RAF

Study type: Interventional

Funder types: Other

Identifiers

NCT01997645

FN HK CP 2013

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Rectal advanced mucosal flap

Active Comparator group

Description:

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.

Treatment:

Procedure: RAF

Ligation of intersphincteric fistula tract

Active Comparator group

Description:

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.

Treatment:

Procedure: LIFT