Anal Fistula SurgeryNCT07102134
The Modified Clipped-LIFT Procedure for High Transsphincteric or Suprasphincteric Fistula
A study testing Suturing-LIFT procedure and Clipped-LIFT procedure in people with Anal Fistula Surgery and Anal Fistula, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
A retrospective analysis was performed on 96 patients who underwent modified LIFT procedures to treat transsphincteric or suprasphincteric fistulas. Two distinct methods were utilized to ligate the internal sphincter side of the intersphincteric tract: one group received conventional ligation with absorbable sutures… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistula Surgery, Anal Fistula
- What is being tested?
- Suturing-LIFT procedure and Clipped-LIFT procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 15 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) preoperative pelvic MRI confirming Parks classification; (2) all patients undergoing a modified LIFT procedure, either with suture ligation (suturing-LIFT group) or clip ligation (clipped-LIFT group).
Who cannot join
- (1) presence of secondary rectal or anal openings identified as unsuitable for LIFT during postoperative evaluation; (2) lack of clinical outcomes following initial modified LIFT procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: The Modified Clipped Ligation of Intersphincteric Fistula Tract (Clipped-LIFT) for High Transsphincteric or Suprasphincteric Fistula: a Proof-of-concept Study
A retrospective analysis was performed on 96 patients who underwent modified LIFT procedures to treat transsphincteric or suprasphincteric fistulas. Two distinct methods were utilized to ligate the internal sphincter side of the intersphincteric tract: one group received conventional ligation with absorbable sutures (Suturing-LIFT, n=74), while the other group was treated with absorbable clips commonly used for vascular or biliary duct occlusion (Clipped-LIFT, n=22). The primary outcome was the one-stage healing rate, which was compared between the two groups, and the safety profile of the clipped-LIFT approach was analyzed. Both univariate and multivariate analyses were conducted to identify potential prognostic factors associated with therapeutic outcomes.
- Conditions
- Anal Fistula Surgery, Anal Fistula
- Being tested
- Suturing-LIFT procedure, Clipped-LIFT procedure
- Keywords
- High anal fistula; Ligation of the Intersphincteric Fistula Tract procedure; Sphincter-preserving; Clipped ligation.
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing-LIFT procedureProcedure or surgery
This group received conventional ligation with absorbable sutures
Clipped-LIFT procedureProcedure or surgery
This group was treated with absorbable clips commonly used for vascular or biliary duct occlusion
| Study group | Role | What they receive |
|---|---|---|
| Suturing-LIFT | Active comparator | This group received conventional ligation with absorbable sutures Receives: Procedure: Suturing-LIFT procedure |
| Clipped-LIFT | Experimental | This group was treated with absorbable clips commonly used for vascular or biliary duct occlusion Receives: Procedure: Clipped-LIFT procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the one-stage healing rate
Measured: Complete wound healing without discharge more than 6 months after the modified LIFT procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Mar 2020
- Primary completion13 Mar 2020
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102134
- Sponsor's protocol ID
- 2024ZSLYEC-053
- Other IDs
- 1010PY(2023)-03
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modified Clipped Ligation of Intersphincteric Fistula Tract (Clipped-LIFT) for High Transsphincteric or Suprasphincteric Fistula: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT07102134
- Acronym / sponsor ID
- 2024ZSLYEC-053
- Conditions
- Anal Fistula Surgery, Anal Fistula
- Keywords
- High anal fistula; Ligation of the Intersphincteric Fistula Tract procedure; Sphincter-preserving; Clipped ligation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 3 Aug 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.
A retrospective analysis was performed on 96 patients who underwent modified LIFT procedures to treat transsphincteric or suprasphincteric fistulas. Two distinct methods were utilized to ligate the internal sphincter side of the intersphincteric tract: one group received conventional ligation with absorbable sutures (Suturing-LIFT, n=74), while the other group was treated with absorbable clips commonly used for vascular or biliary duct occlusion (Clipped-LIFT, n=22). The primary outcome was the one-stage healing rate, which was compared between the two groups, and the safety profile of the clipped-LIFT approach was analyzed. Both univariate and multivariate analyses were conducted to identify potential prognostic factors associated with therapeutic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suturing-LIFT | Active comparator | Procedure: Suturing-LIFT procedureThis group received conventional ligation with absorbable sutures |
| Clipped-LIFT | Experimental | Procedure: Clipped-LIFT procedureThis group was treated with absorbable clips commonly used for vascular or biliary duct occlusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1) preoperative pelvic MRI confirming Parks classification; (2) all patients undergoing a modified LIFT procedure, either with suture ligation (suturing-LIFT group) or clip ligation (clipped-LIFT group).
Key exclusion criteria (1 listed)
- (1) presence of secondary rectal or anal openings identified as unsuitable for LIFT during postoperative evaluation; (2) lack of clinical outcomes following initial modified LIFT procedure.
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 |
|---|---|---|
| Suturing-LIFT procedureThis group received conventional ligation with absorbable sutures | Procedure or surgery | Suturing-LIFT |
| Clipped-LIFT procedureThis group was treated with absorbable clips commonly used for vascular or biliary duct occlusion | Procedure or surgery | Clipped-LIFT |
Primary outcome
the one-stage healing rate
Time frame: Complete wound healing without discharge more than 6 months after the modified LIFT procedure
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 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing-LIFT procedure and Clipped-LIFT procedure in people with Anal Fistula Surgery and Anal Fistula, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 1 inclusion and 1 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 3 Aug 2025. 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 China. 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?
the one-stage healing rate (time frame: Complete wound healing without discharge more than 6 months after the modified LIFT procedure). 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 3 Aug 2025.