Anal Fistula, Rectal Fistula
Conditions
Keywords
Anal fistula, Rectal fistula, Intersphincteric fistula, Perianal fistula
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.
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | One year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 14 days | 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). |
| Pre- and postoperative continence | One year | Pre- and postoperative continence will be evaluated with Wexner score. |
| Postoperative morbidity | One month | Will be evaluated according to Clavien-Dindo classification. |
| Quality of life | One year | For quality of life evaluation SF-36 questionnaire will be used. |
Countries
Czechia
Contacts
Primary ContactJúlius Örhalmi, MD
Outcome results
None listed