Perianal Fistula
Conditions
Keywords
LIFT, perianal fistula, LASER
Brief summary
\>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.
Detailed description
\> 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.
Interventions
PROCEDUREfistula lay open
lay open of fistula tract
PROCEDURELIFT plus LASER
ligation of inter-sphincteric tract plus LASER of tract
PROCEDUREopen LIFT plus LASER
cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Title: Randomized Controlled Trial Comparing Fistulotomy vs LIFT with Laser Ablation vs Open LIFT plus Laser in the Treatment of Transsphincteric Perianal Fistula Objective: To compare healing rate, recurrence, pain, and functional outcomes among three surgical techniques for transsphincteric fistula. Design: Single-center, prospective, randomized controlled trial Three parallel arms 90 participants total (30 per group) Inclusion Criteria: Adults aged 18-65 Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula Primary (first-time) surgery Able to provide informed consent Exclusion Criteria: Crohn's disease or other inflammatory bowel disease Suprasphincteric, extrasphincteric, or horseshoe fistulas Previous fistula surgery Active perianal abscess Current immunosuppression Pregnant or breastfeeding women Primary Outcome: Clinical healing (no discharge, closure of opening) at 6 months Secondary Outcomes: Recurrence at 12 months Postoperative
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 * Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula * Primary (first-time) surgery * Able to provide informed consent
Exclusion criteria
* Crohn's disease or other inflammatory bowel disease * Suprasphincteric, extrasphincteric, or horseshoe fistulas * Previous fistula surgery * Active perianal abscess * Current immunosuppression * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| healing | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fistula manegment score above 7 consider non healing | 12 months | 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 | 6 months | 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 |
Contacts
Primary ContactWalid galal Elshazly, PROF
Backup Contactomar walid ELShazly, GP
Outcome results
None listed