Randomised controlled trial comparing ligation of the intersphicteric fistula tract vs advancement flap for complex anorectal fistulas requiring intial seton drainage

Does ligation of the intersphicteric fistula tract provide at least a 40% improvement in recurrence rate compared with anorectal advancement flap: A randomised controlled trial comparing ligation of the intersphicteric fistula tract with advancement flap for complex anorectal fistulas requiring intial seton drainage

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000522910

Acronym

Nil

Enrollment

Registered

2011-05-20

Start date

2007-12-08

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A new method of treating difficult anorectal fistulae was compared with the traditionally accepted approach. Management of this condition is known to have a relatively high recurrence rate. Treatment also carries a risk of faecal incontinence. Our results show after seton drainage of infection the new method ligation of the intersphicteric fistula tract (LIFT) is at least as good as traditional anorectal advancement flap method with regard to recurrences.

Interventions

A probe was inserted into the tract an incision then made in the intersphincteric groove and the fistula tract identified in this space. Once the tract is dissected free it is encircled and the probe removed. The fistula tract is then divided and transfixed both sides with 3/0 PDS. The external opening is left open the internal opening is curetted and closed with a vicryl suture. This is a single intervention. Operation duration is approximately 10 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with transsphincteric or complex fistulas were entered into the study. Fistulas were classified as complex if any of the following were present: tract crossing more than 30% to 50% of the external sphincter, anterior fistula in a woman, multiple tracts, recurrent fistula, pre-existing incontinence or Crohns disease.

Exclusion criteria

Patients with Crohns disease were excluded

Outcome results