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>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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lay open | Active Comparator | fistula lay open of the tract |
|
| LIFT plus LASER | Active Comparator | ligation of inters-sphincteric tract plus laser for the outer tract |
|
| open LIFT plus LASER | Active Comparator | cutting internal sphincter and ligation of tract plus LASER to outer part |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fistula lay open | Procedure | lay open of fistula tract |
| |
| LIFT plus LASER |
| Measure | Description | Time Frame |
|---|---|---|
| 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
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
8 - 11 moderate 12 - 17 severe | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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
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
8 - 11 moderate 12 - 17 severe Score above 7 consider non healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walid galal Elshazly, PROF | Contact | +201221100756 | wshazly@gmail.com | |
| omar walid ELShazly, GP | Contact | +201110711943 | omarshazly2001@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Walid GALAL Elshazly, Prof | University of Alexandria | Principal Investigator |
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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
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| Procedure |
ligation of inter-sphincteric tract plus LASER of tract |
|
| open LIFT plus LASER | Procedure | cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER |
|
| 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.
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 | 6 months |
| ID | Term |
|---|---|
| D017770 | Lifting |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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