\>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.
\> Transsphincteric perianal fistula presents a surgical challenge due to the need to balance fistula eradication with continence preservation. While fistulotomy is associated with high healing rates, it carries a risk of sphincter damage. Ligation of the intersphincteric tract (LIFT) offers a sphincter-sparing alternative, and the use of endofistula laser ablation (FiLaC or diode laser) has shown promise in enhancing outcomes. This study will enroll 90 patients with confirmed transsphincteric cryptoglandular perianal fistula and randomize them equally into three arms: Group A: Conventional fistulotomy (lay open). Group B: LIFT procedure with endofistula laser ablation using a radial laser fiber. Group C: Open LIFT with direct laser ablation of the tract under vision. The primary endpoint is complete clinical healing at 6 months. Secondary outcomes include recurrence rates at 12 months, pain scores (VAS), continence outcomes (Wexner score), return to daily activities, and patient satisfaction. The study aims to determine the optimal balance between healing efficacy and preservation of continence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
lay open of fistula tract
ligation of inter-sphincteric tract plus LASER of tract
cutting 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
Time frame: 6 months
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
Time frame: 12 months
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
Time frame: 6 months
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