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Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track

Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03636997
Enrollment
60
Registered
2018-08-17
Start date
2017-02-01
Completion date
2018-07-30
Last updated
2018-08-17

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

Conditions

Anal Fistula

Brief summary

This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula

Detailed description

Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence. The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.

Interventions

PROCEDUREDraining seton

Number 1 silk suture was passed through the fistula track and tied as loose seton

PROCEDURERerouting of track

The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula

Exclusion criteria

* Patients with simple anal fistula. * Patients with acute anorectal sepsis. * Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation. * Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy. * Patients with history of previous surgical treatment of anal fistula. * Patients with symptomatic preoperative fecal incontinence.

Design outcomes

Primary

MeasureTime frameDescription
Healing time6 months after surgeryTime required to achieve complete healing of the anal fistula

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026