Anal Fistula SurgeryNCT07603635
Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula
A study testing Standard LIFT and Modified LIFT via a Lateral Approach in people with Anal Fistula Surgery and Transsphincteric Anal Fistula, run by Tugberk Tok at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Fistula Surgery, Transsphincteric Anal Fistula
- What is being tested?
- Standard LIFT and Modified LIFT via a Lateral Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging
- Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage
- Ability and willingness to provide written informed consent
- Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach
Who cannot join
- Previous definitive surgery for perianal fistula other than abscess drainage
- Perianal Crohn disease
- Horseshoe fistula
- Colorectal cancer
- Malnutrition
- Recurrent anal fistula
Show all 9Show fewer
- Previous radiotherapy or chemotherapy
- Chronic medication use that could impair wound healing, such as steroids or colchicine
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Training and Research Hospital
Kayseri, Kayseri, 38300
About this study
Official title: Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study
This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.
Read the detailed description
This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.
Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.
The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.
- Being tested
- Standard LIFT, Modified LIFT via a Lateral Approach
- Keywords
- Anal fistula, Transsphincteric fistula, LIFT, Ligation of intersphincteric fistula tract, Modified LIFT, Sphincter-preserving surgery, Perianal fistula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard LIFTProcedure or surgery
Standard ligation of the intersphincteric fistula tract was performed. The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.
Modified LIFT via a Lateral ApproachProcedure or surgery
Modified LIFT via a lateral approach was performed. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed.
| Study group | Role | What they receive |
|---|---|---|
| Modified LIFT via a Lateral Approach | Active comparator | Participants assigned to this arm underwent modified LIFT via a lateral approach. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at this level, and the remaining defect and internal opening were closed while preserving sphincter integrity. Receives: Procedure: Modified LIFT via a Lateral Approach |
| Standard LIFT | Active comparator | Participants assigned to this arm underwent standard ligation of the intersphincteric fistula tract (LIFT). The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique. Receives: Procedure: Standard LIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Time
Time from surgery to complete clinical epithelialization of the perianal wound without discharge.
Measured: Up to 12 weeks after surgery
Secondary outcomes (3)
Early Recurrence or Persistence of Anal Fistula
Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up.
Measured: Postoperative weeks 1, 4, 8, and 12
Postoperative Pain Assessed Using the Visual Analog Scale
Postoperative pain will be assessed using the Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Measured: Postoperative weeks 1, 4, 8, and 12
Fecal Continence Assessed Using the Wexner Fecal Incontinence Score
Fecal continence will be assessed using the Wexner Fecal Incontinence Score. The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate worse continence.
Measured: Postoperative weeks 1, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal Fistula SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tugberk Tok
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tugberk Tok, Kayseri Training and Research Hospital
- Investigators
- Tuğberk Tok, MD, Principal investigator, Kayseri City Training and Research HospitalYusuf Sevim, MD, Study director, Kayseri City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603635
- Sponsor's protocol ID
- KCTRH-LIFT-944-2023
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to ethical, institutional, and privacy restrictions. De-identified data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.
Publications
Tok T, Sevim Y. Modified LIFT via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study. Ann Ital Chir. 2026 Oct 14;97(10):1813-1821. doi: 10.62713/aic.4784.
PubMed 42894916
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07603635
- Acronym / sponsor ID
- KCTRH-LIFT-944-2023
- Keywords
- Anal fistula, Transsphincteric fistula, LIFT, Ligation of intersphincteric fistula tract, Modified LIFT, Sphincter-preserving surgery, Perianal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tugberk TokOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 22 May 2026 (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 study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.
Detailed description
This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.
Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.
The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified LIFT via a Lateral Approach | Active comparator | Procedure: Modified LIFT via a Lateral ApproachParticipants assigned to this arm underwent modified LIFT via a lateral approach. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at this level, and the remaining defect and internal opening were closed while preserving sphincter integrity. |
| Standard LIFT | Active comparator | Procedure: Standard LIFTParticipants assigned to this arm underwent standard ligation of the intersphincteric fistula tract (LIFT). The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 75 years
- Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging
- Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage
- Ability and willingness to provide written informed consent
- Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach
Key exclusion criteria (9 listed)
- Previous definitive surgery for perianal fistula other than abscess drainage
- Perianal Crohn disease
- Horseshoe fistula
- Colorectal cancer
- Malnutrition
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 |
|---|---|---|
| Standard LIFTStandard ligation of the intersphincteric fistula tract was performed. The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique. | Procedure or surgery | Standard LIFT |
| Modified LIFT via a Lateral ApproachModified LIFT via a lateral approach was performed. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed. | Procedure or surgery | Modified LIFT via a Lateral Approach |
Primary outcome
Wound Healing Time
Time frame: Up to 12 weeks after surgery
Time from surgery to complete clinical epithelialization of the perianal wound without discharge.
3 secondary outcomes
Early Recurrence or Persistence of Anal Fistula
Time frame: Postoperative weeks 1, 4, 8, and 12
Postoperative Pain Assessed Using the Visual Analog Scale
Time frame: Postoperative weeks 1, 4, 8, and 12
Fecal Continence Assessed Using the Wexner Fecal Incontinence Score
Time frame: Postoperative weeks 1, 4, 8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Derived from this study: PubMed 42894916Tok T, Sevim Y. Modified LIFT via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study. Ann Ital Chir. 2026 Oct 14;97(10):1813-1821. doi: 10.62713/aic.4784.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to ethical, institutional, and privacy restrictions. De-identified data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.
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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. This study is not recruiting at the moment.
Tuğberk Tok, MD principal investigator
Kayseri City Training and Research Hospital
Yusuf Sevim, MD study director
Kayseri City Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard LIFT and Modified LIFT via a Lateral Approach in people with Anal Fistula Surgery and Transsphincteric Anal Fistula, run by Tugberk Tok at 1 site in Turkey (Türkiye).
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Time (time frame: Up to 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07603635, which also lists 1 linked publication.
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 26 May 2026.