\>This randomized clinical trial compares three different surgical techniques for the treatment of transsphincteric perianal fistula: (1) traditional fistulotomy (lay open), (2) ligation of the intersphincteric tract (LIFT) with adjunctive endofistula laser ablation, and (3) open LIFT procedure followed by direct laser ablation of the tract under vision. The aim is to determine which approach offers the highest healing rate, lowest recurrence, and best postoperative outcomes with minimal impact on continence.
Adults aged 18-65
Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
Primary (first-time) surgery
Able to provide informed consent
Crohn's disease or other inflammatory bowel disease
Suprasphincteric, extrasphincteric, or horseshoe fistulas
Previous fistula surgery
Active perianal abscess
Parallel
fistula lay open
Procedure/Surgerylay open of fistula tract
LIFT plus LASER
Procedure/Surgeryligation of inter-sphincteric tract plus LASER of tract
open LIFT plus LASER
Procedure/Surgerycutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER
healing
Baseline Fistula manegment score → Pre-op disease severity Post-op Fm-score at 1, 3, 6 months → Objective clinical healing Where Total score = Pain + Discharge + Continence + QOL with Range = 0-16 Pain (0-4) 0 No pain 1. Mild, occasional pain, no analgesics needed 2. Moderate pain occasional analgesics 3. Severe pain regular analgesics 4. Constant, severe pain interfering with daily activities Discharge (0-4) 0 No discharge 1 Occasional spotting, no pad required 2 Daily discharge, small amount, 1 pad/day 3 Moderate discharge requiring \>1 pad/day 4 Persistent heavy discharge; soaking pads; malodorous Continence (0-4) 0 Full continence 1 Gas incontinence only 2 Occasional soiling or minor liquid incontinence 3 Frequent soiling; liquid stool incontinence 4 Solid stool incontinence Quality of Life (QoL) 0 No impact on life 1. Mild limitation 2. Moderate impact 3. Significant impact 4. Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease 8 - 11 moderate 12 - 17 severe
Fistula manegment score above 7 consider non healing
Baseline Fistula manegment score → Pre-op disease severity Post-op Fm-score at 12 months → Objective clinical non healing Where Total score = Pain + Discharge + Continence + QOL with Range = 0-16 Pain (0-4) 0 No pain 1. Mild, occasional pain, no analgesics needed 2. Moderate pain occasional analgesics 3. Severe pain regular analgesics 4. Constant, severe pain interfering with daily activities Discharge (0-4) 0 No discharge 1 Occasional spotting, no pad required 2 Daily discharge, small amount, 1 pad/day 3 Moderate discharge requiring \>1 pad/day 4 Persistent heavy discharge; soaking pads; malodorous Continence (0-4) 0 Full continence 1 Gas incontinence only 2 Occasional soiling 3 Frequent soiling 4 Solid stool incontinence Quality of Life (QoL) 0 No impact on life 1. Mild limitation 2. Moderate impact 3. Significant impact 4. Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease 8 - 11 moderate 12 - 17 severe Score above 7 consider non healing
continence level. Assessed by wexener incontinence score
Wexner score is clinical tool used to quantify the severity of fecal incontinence. five specific components, and each component is scored from 0 to 4. The total score ranges from 0 to 20, where 0 represents perfect continence and 20 represents complete incontinence. Incontinence to solid stool: 0 means this never occurs. 1. means it happens rarely (\> once a month). 2. indicates it occurs sometimes (\> once a week). 3. means it happens usually (\< once a week). 4. reflects constant or daily incontinence. Incontinence to liquid stool: Scored in the same way as solids, from 0 (never) to 4 (always). Incontinence to gas: scored from 0 to 4 using the same frequency scale. Use of pads for protection: Scored from 0 (no need for pads) to 4 (pads required all the time). 5. Lifestyle alteration due to incontinence: 0 means no effect on lifesty and 4 sever effect 0: Perfect continence 1-5: Mild incontinence 6-10: Moderate 11-20 severe
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
