Anal Fistula Surgery, Transsphincteric Anal Fistula
Conditions
Keywords
Anal fistula, Transsphincteric fistula, LIFT, Ligation of intersphincteric fistula tract, Modified LIFT, Sphincter-preserving surgery, Perianal fistula
Brief summary
This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.
Detailed description
This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent. Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12. The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.
Interventions
PROCEDUREStandard LIFT
Standard ligation of the intersphincteric fistula tract was performed. The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.
PROCEDUREModified LIFT via a Lateral Approach
Modified LIFT via a lateral approach was performed. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed.
Sponsors
Tugberk Tok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 years * Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging * Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage * Ability and willingness to provide written informed consent * Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach
Exclusion criteria
* Previous definitive surgery for perianal fistula other than abscess drainage * Perianal Crohn disease * Horseshoe fistula * Colorectal cancer * Malnutrition * Recurrent anal fistula * Previous radiotherapy or chemotherapy * Chronic medication use that could impair wound healing, such as steroids or colchicine * Refusal or inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Time | Up to 12 weeks after surgery | Time from surgery to complete clinical epithelialization of the perianal wound without discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Recurrence or Persistence of Anal Fistula | Postoperative weeks 1, 4, 8, and 12 | Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up. |
| Postoperative Pain Assessed Using the Visual Analog Scale | Postoperative weeks 1, 4, 8, and 12 | Postoperative pain will be assessed using the Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. |
| Fecal Continence Assessed Using the Wexner Fecal Incontinence Score | Postoperative weeks 1, 4, 8, and 12 | Fecal continence will be assessed using the Wexner Fecal Incontinence Score. The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate worse continence. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORTuğberk Tok, MD
Kayseri City Training and Research Hospital
STUDY_DIRECTORYusuf Sevim, MD
Kayseri City Training and Research Hospital
Outcome results
None listed