Clinical Trial: Surgical Treatment of High Perianal Fistulas

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University Hospital Hradec Kralove

Current Primary Outcome: Recurrence rate [ Time Frame: 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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative pain [ Time Frame: 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 [ Time Frame: One year ]
    Pre- and postoperative continence will be evaluated with Wexner score.
  • Postoperative morbidity [ Time Frame: One month ]
    Will be evaluated according to Clavien-Dindo classification.
  • Quality of life [ Time Frame: One year ]
    For quality of life evaluation SF-36 questionnaire will be used.


Original Secondary Outcome: Same as current

Information By: University Hospital Hradec Kralove

Dates:
Date Received: November 22, 2013
Date Started: November 2013
Date Completion:
Last Updated: November 22, 2013
Last Verified: November 2013