Anal FistulaLIFT-SETONNCT07579715
Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In Perianal Fistula
A study testing Ligation of Intersphincteric Fistula Tract (LIFT) and Fistulotomy with Seton Placement in people with Anal Fistula and Perianal Fistula, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial summary
This study aims to compare two commonly used surgical techniques for the treatment of perianal fistula: Ligation of the Intersphincteric Fistula Tract (LIFT) and fistulotomy with seton. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fistula, Perianal Fistula, Fistula-in-ano
- What is being tested?
- Ligation of Intersphincteric Fistula Tract (LIFT) and Fistulotomy with Seton Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 May 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years, both males and females
- Diagnosed with primary cryptoglandular perianal fistula
- Trans-sphincteric or inter-sphincteric fistula confirmed clinically ± imaging/proctoscopy
- Fit for surgery under anesthesia
- Willing to provide written informed consent
Who cannot join
- Recurrent perianal fistula (previous surgical intervention)
- Fistula secondary to Crohn's disease, tuberculosis, or malignancy Immunocompromised patients
- Pre-existing fecal incontinence (documented)
- Severe comorbidities making surgery unsafe (e.g., uncontrolled diabetes, severe hepatic/renal failure)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Akbar Niazi Teaching Hospital, Islamabad Medical and Dental College
Islamabad, 44000
About this study
Official title: Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In The Management Of Perianal Fistula: An Analytical Comparative Study
This study aims to compare two commonly used surgical techniques for the treatment of perianal fistula: Ligation of the Intersphincteric Fistula Tract (LIFT) and fistulotomy with seton. Perianal fistula is a condition that can cause pain, discharge, and significant discomfort, and its treatment remains challenging due to the risk of recurrence and potential loss of bowel control after surgery.
The LIFT procedure is a sphincter-preserving technique designed to treat the fistula without damaging the muscles responsible for continence. In contrast, fistulotomy with seton involves placing a thread (seton) in the fistula tract followed by gradual or staged division of the tract, which may carry a higher risk of affecting continence.
Read more
In this study, 100 adult patients diagnosed with perianal fistula will be included and divided into two groups based on the surgical procedure they undergo: LIFT or fistulotomy with seton. The outcomes of both procedures will be compared in terms of wound healing time, recurrence of the fistula, postoperative pain, and preservation of bowel continence.
The results of this study will help determine which surgical technique provides better recovery, fewer complications, and improved quality of life for patients.
Read the detailed description
Perianal fistula (fistula-in-ano) is a common anorectal condition characterized by an abnormal tract between the anal canal and perianal skin. It is associated with recurrent infection, discharge, and discomfort, and often requires surgical management. However, the ideal surgical technique remains controversial due to the balance required between complete eradication of the fistula tract and preservation of anal sphincter function.
Traditional surgical approaches such as fistulotomy involve laying open the fistula tract but may result in varying degrees of sphincter muscle division, leading to potential fecal incontinence. To overcome this limitation, sphincter-preserving techniques such as the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure have been introduced. LIFT involves identification and ligation of the fistula tract in the intersphincteric plane, thereby minimizing damage to the anal sphincter.
Fistulotomy with seton placement is another commonly practiced technique, especially for trans-sphincteric fistulas. The seton allows gradual drainage and fibrosis before definitive fistulotomy, potentially reducing the risk of uncontrolled sphincter division but still carrying a risk of incontinence.
Despite numerous international studies comparing these techniques, results remain inconsistent due to variations in study design, patient populations, and surgical expertise. Moreover, limited local data from Pakistan necessitates further research to guide clinical decision-making in this setting.
This analytical comparative study will be conducted at the Colorectal and General Surgery Department of Akbar Niazi Teaching Hospital, Islamabad. A total of 100 patients aged 18-65 years with primary trans-sphincteric or inter-sphincteric perianal fistula will be included using non-probability consecutive sampling. Patients will be allocated into two groups based on the surgical procedure performed: Group A (LIFT) and Group B (fistulotomy with seton).
Preoperative data including demographic characteristics, fistula type, and baseline continence scores will be recorded. Surgical procedures will be standardized and performed or supervised by experienced surgeons. Postoperative follow-up will be conducted at 2, 4, 8, and 12 weeks to assess outcomes.
The primary outcome of the study is preservation of fecal continence at 12 weeks, assessed using a validated continence scoring system. Secondary outcomes include wound healing time, recurrence rate, postoperative pain scores, and overall complication rate.
Data will be analyzed using statistical software. Continuous variables will be compared using independent-sample t-tests, while categorical variables will be analyzed using chi-square tests. A p-value of less than 0.05 will be considered statistically significant. Multivariate analysis may be performed to adjust for confounding factors.
This study aims to provide evidence on the comparative effectiveness and safety of LIFT versus fistulotomy with seton, helping surgeons select the most appropriate technique with optimal patient outcomes and minimal complications.
- Conditions
- Anal Fistula, Perianal Fistula, Fistula-in-ano
- Being tested
- Ligation of Intersphincteric Fistula Tract (LIFT), Fistulotomy with Seton Placement
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligation of Intersphincteric Fistula Tract (LIFT)Procedure or surgery
A sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter function.
Fistulotomy with Seton PlacementProcedure or surgery
A surgical approach involving placement of a seton through the fistula tract followed by fistulotomy (laying open of the tract) as definitive management for perianal fistula.
| Study group | Role | What they receive |
|---|---|---|
| Lift Group | Active comparator | Participants in this arm will undergo the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure for the management of primary trans-sphincteric or inter-sphincteric perianal fistula. This is a sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter integrity. Postoperative outcomes, including wound healing time, recurrence, postoperative pain, and faecal continence, will be assessed and compared with the fistulotomy with seton group during follow-up. Receives: Procedure: Ligation of Intersphincteric Fistula Tract (LIFT) |
| Fistulotomy With Seton Group | Active comparator | Participants in this arm will undergo fistulotomy with seton placement followed by definitive fistulotomy for the management of primary trans-sphincteric or inter-sphincteric perianal fistula. The seton is used initially to allow drainage and fibrosis of the fistula tract, followed by surgical laying open of the tract (fistulotomy) as definitive treatment. Postoperative outcomes, including wound healing time, recurrence rate, postoperative pain, and faecal continence, will be evaluated and compared with the LIFT group during scheduled follow-up visits. Receives: Procedure: Fistulotomy with Seton Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Continence Preservation
Measured: 12 weeks
Secondary outcomes (2)
Wound Healing Time
Measured: 12 weeks
Recurrence Rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jan 2026
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies 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
- Model description
- Participants will be assigned into two parallel groups based on the surgical procedure received. Group A will undergo Ligation of the Intersphincteric Fistula Tract (LIFT) procedure, while Group B will undergo fistulotomy with seton placement followed by definitive fistulotomy. Outcomes will be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579715
- Sponsor's protocol ID
- CRS-2024-135-7
- Acronym
- LIFT-SETON
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In The Management Of Perianal Fistula: An Analytical Comparative Study
- ClinicalTrials.gov ID
- NCT07579715
- Acronym / sponsor ID
- LIFT-SETON / CRS-2024-135-7
- Conditions
- Anal Fistula, Perianal Fistula, Fistula-in-ano
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 12 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 aims to compare two commonly used surgical techniques for the treatment of perianal fistula: Ligation of the Intersphincteric Fistula Tract (LIFT) and fistulotomy with seton. Perianal fistula is a condition that can cause pain, discharge, and significant discomfort, and its treatment remains challenging due to the risk of recurrence and potential loss of bowel control after surgery.
The LIFT procedure is a sphincter-preserving technique designed to treat the fistula without damaging the muscles responsible for continence. In contrast, fistulotomy with seton involves placing a thread (seton) in the fistula tract followed by gradual or staged division of the tract, which may carry a higher risk of affecting continence.
In this study, 100 adult patients diagnosed with perianal fistula will be included and divided into two groups based on the surgical procedure they undergo: LIFT or fistulotomy with seton. The outcomes of both procedures will be compared in terms of wound healing time, recurrence of the fistula, postoperative pain, and preservation of bowel continence.
The results of this study will help determine which surgical technique provides better recovery, fewer complications, and improved quality of life for patients.
Detailed description
Perianal fistula (fistula-in-ano) is a common anorectal condition characterized by an abnormal tract between the anal canal and perianal skin. It is associated with recurrent infection, discharge, and discomfort, and often requires surgical management. However, the ideal surgical technique remains controversial due to the balance required between complete eradication of the fistula tract and preservation of anal sphincter function.
Traditional surgical approaches such as fistulotomy involve laying open the fistula tract but may result in varying degrees of sphincter muscle division, leading to potential fecal incontinence. To overcome this limitation, sphincter-preserving techniques such as the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure have been introduced. LIFT involves identification and ligation of the fistula tract in the intersphincteric plane, thereby minimizing damage to the anal sphincter.
Fistulotomy with seton placement is another commonly practiced technique, especially for trans-sphincteric fistulas. The seton allows gradual drainage and fibrosis before definitive fistulotomy, potentially reducing the risk of uncontrolled sphincter division but still carrying a risk of incontinence.
Despite numerous international studies comparing these techniques, results remain inconsistent due to variations in study design, patient populations, and surgical expertise. Moreover, limited local data from Pakistan necessitates further research to guide clinical decision-making in this setting.
This analytical comparative study will be conducted at the Colorectal and General Surgery Department of Akbar Niazi Teaching Hospital, Islamabad. A total of 100 patients aged 18-65 years with primary trans-sphincteric or inter-sphincteric perianal fistula will be included using non-probability consecutive sampling. Patients will be allocated into two groups based on the surgical procedure performed: Group A (LIFT) and Group B (fistulotomy with seton).
Preoperative data including demographic characteristics, fistula type, and baseline continence scores will be recorded. Surgical procedures will be standardized and performed or supervised by experienced surgeons. Postoperative follow-up will be conducted at 2, 4, 8, and 12 weeks to assess outcomes.
The primary outcome of the study is preservation of fecal continence at 12 weeks, assessed using a validated continence scoring system. Secondary outcomes include wound healing time, recurrence rate, postoperative pain scores, and overall complication rate.
Data will be analyzed using statistical software. Continuous variables will be compared using independent-sample t-tests, while categorical variables will be analyzed using chi-square tests. A p-value of less than 0.05 will be considered statistically significant. Multivariate analysis may be performed to adjust for confounding factors.
This study aims to provide evidence on the comparative effectiveness and safety of LIFT versus fistulotomy with seton, helping surgeons select the most appropriate technique with optimal patient outcomes and minimal complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned into two parallel groups based on the surgical procedure received. Group A will undergo Ligation of the Intersphincteric Fistula Tract (LIFT) procedure, while Group B will undergo fistulotomy with seton placement followed by definitive fistulotomy. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Lift Group | Active comparator | Procedure: Ligation of Intersphincteric Fistula Tract (LIFT)Participants in this arm will undergo the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure for the management of primary trans-sphincteric or inter-sphincteric perianal fistula. This is a sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter integrity. Postoperative outcomes, including wound healing time, recurrence, postoperative pain, and faecal continence, will be assessed and compared with the fistulotomy with seton group during follow-up. |
| Fistulotomy With Seton Group | Active comparator | Procedure: Fistulotomy with Seton PlacementParticipants in this arm will undergo fistulotomy with seton placement followed by definitive fistulotomy for the management of primary trans-sphincteric or inter-sphincteric perianal fistula. The seton is used initially to allow drainage and fibrosis of the fistula tract, followed by surgical laying open of the tract (fistulotomy) as definitive treatment. Postoperative outcomes, including wound healing time, recurrence rate, postoperative pain, and faecal continence, will be evaluated and compared with the LIFT group during scheduled follow-up visits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-65 years, both males and females
- Diagnosed with primary cryptoglandular perianal fistula
- Trans-sphincteric or inter-sphincteric fistula confirmed clinically ± imaging/proctoscopy
- Fit for surgery under anesthesia
- Willing to provide written informed consent
Key exclusion criteria (5 listed)
- Recurrent perianal fistula (previous surgical intervention)
- Fistula secondary to Crohn's disease, tuberculosis, or malignancy Immunocompromised patients
- Pre-existing fecal incontinence (documented)
- Severe comorbidities making surgery unsafe (e.g., uncontrolled diabetes, severe hepatic/renal failure)
- Pregnancy
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 |
|---|---|---|
| Ligation of Intersphincteric Fistula Tract (LIFT)A sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter function. | Procedure or surgery | Lift Group |
| Fistulotomy with Seton PlacementA surgical approach involving placement of a seton through the fistula tract followed by fistulotomy (laying open of the tract) as definitive management for perianal fistula. | Procedure or surgery | Fistulotomy With Seton Group |
Primary outcome
Fecal Continence Preservation
Time frame: 12 weeks
2 secondary outcomes
Wound Healing Time
Time frame: 12 weeks
Recurrence Rate
Time frame: 12 weeks
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 Jun 2026.
- 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. 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 Ligation of Intersphincteric Fistula Tract (LIFT) and Fistulotomy with Seton Placement in people with Anal Fistula and Perianal Fistula, run by Islamabad Medical and Dental College at 1 site in Pakistan.
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 5 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 Jun 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 Pakistan. 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?
Fecal Continence Preservation (time frame: 12 weeks). 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 Jun 2026.