Perianal FistulaNCT07236047
Comparing Three Surgical Techniques for the Treatment of Transsphincteric Perianal Fistula: (1) Traditional Fistulotomy (Lay Open), (2) Ligation of the Intersphincteric Tract (LIFT) With Adjunctive Endo Fistula Laser Ablation, and (3) Open LIFT Procedure Followed by LASER
A study testing fistula lay open, LIFT plus LASER and open LIFT plus LASER in people with Perianal Fistula, run by Alexandria University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- fistula lay open, LIFT plus LASER and open LIFT plus LASER
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65
- Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
- Primary (first-time) surgery
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Trial Comparing Fistulotomy vs LIFT Plus Laser Ablation vs Open LIFT Plus Laser in the Treatment of Trans-sphincteric Perianal Fistula
>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.
Read the 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.
- Conditions
- Perianal Fistula
- Being tested
- fistula lay open, LIFT plus LASER, open LIFT plus LASER
- Keywords
- LIFT, perianal fistula, LASER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fistula lay openProcedure or surgery
lay open of fistula tract
LIFT plus LASERProcedure or surgery
ligation of inter-sphincteric tract plus LASER of tract
open LIFT plus LASERProcedure or surgery
cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER
| Study group | Role | What they receive |
|---|---|---|
| lay open | Active comparator | fistula lay open of the tract Receives: Procedure: fistula lay open |
| LIFT plus LASER | Active comparator | ligation of inters-sphincteric tract plus laser for the outer tract Receives: Procedure: LIFT plus LASER |
| open LIFT plus LASER | Active comparator | cutting internal sphincter and ligation of tract plus LASER to outer part Receives: Procedure: open LIFT plus LASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Mild, occasional pain, no analgesics needed
- Moderate pain occasional analgesics
- Severe pain regular analgesics
- 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
- Mild limitation
- Moderate impact
- Significant impact
- Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease
8 - 11 moderate 12 - 17 severe
Measured: 6 months
Secondary outcomes (2)
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
- Mild, occasional pain, no analgesics needed
- Moderate pain occasional analgesics
- Severe pain regular analgesics
- 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
- Mild limitation
- Moderate impact
- Significant impact
- Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease
8 - 11 moderate 12 - 17 severe Score above 7 consider non healing
Measured: 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.
- means it happens rarely (> once a month).
- indicates it occurs sometimes (> once a week).
- means it happens usually (< once a week).
- 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walid GALAL Elshazly, Prof, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236047
- Sponsor's protocol ID
- 0307609
- Status last verified
- Apr 2025
- First submitted
- 13 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Fistulotomy vs LIFT Plus Laser Ablation vs Open LIFT Plus Laser in the Treatment of Trans-sphincteric Perianal Fistula
- ClinicalTrials.gov ID
- NCT07236047
- Acronym / sponsor ID
- 0307609
- Conditions
- Perianal Fistula
- Keywords
- LIFT, perianal fistula, LASER
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
>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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| lay open | Active comparator | Procedure: fistula lay openfistula lay open of the tract |
| LIFT plus LASER | Active comparator | Procedure: LIFT plus LASERligation of inters-sphincteric tract plus laser for the outer tract |
| open LIFT plus LASER | Active comparator | Procedure: open LIFT plus LASERcutting internal sphincter and ligation of tract plus LASER to outer part |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65
- Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
- Primary (first-time) surgery
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Crohn's disease or other inflammatory bowel disease
- Suprasphincteric, extrasphincteric, or horseshoe fistulas
- Previous fistula surgery
- Active perianal abscess
- Current immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fistula lay openlay open of fistula tract | Procedure or surgery | lay open |
| LIFT plus LASERligation of inter-sphincteric tract plus LASER of tract | Procedure or surgery | LIFT plus LASER |
| open LIFT plus LASERcutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER | Procedure or surgery | open LIFT plus LASER |
Primary outcome
healing
Time frame: 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
2 secondary outcomes
Fistula manegment score above 7 consider non healing
Time frame: 12 months
continence level. Assessed by wexener incontinence score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walid GALAL Elshazly, Prof principal investigator
University of Alexandria
Questions about this trial
What is this clinical trial studying?
A study testing fistula lay open, LIFT plus LASER and open LIFT plus LASER in people with Perianal Fistula, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walid galal Elshazly, PROF (+201221100756, wshazly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.