Anal Fistula
Conditions
Brief summary
This study aims to compare the efficacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.
Interventions
PROCEDURERerouting seton
Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter
PROCEDURELIFT
Ligation of the intersphincteric fistula tract
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female
Exclusion criteria
* Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas. * ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients * Patient with any grade of anal incontinence. * Patients with concomitant anal pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Healing of anal fistula | 12 months after surgery | Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge |
Countries
Egypt
Contacts
Primary ContactSameh H Emile, M.D., FACS
Outcome results
None listed