Anal FistulaNCT05933343
Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas
A study testing Ethibond suture and Vessel loop in people with Anal Fistula, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Ethibond suture and Vessel loop
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2023to 16 Oct 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older of either sex who present with CAF will be included. Both cryptoglandular fistulas and fistulas secondary to inflammatory bowel disease (IBD)
Who cannot join
- Simple anal fistulas
- Fistulas secondary to malignancy or irradiation therapy
- Pregnant women
- Patients with pre-existing setons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ethibond Suture Compared to Vessel Loop as Draining Seton for Complex Anal Fistulas; a Multicenter Randomized Clinical Trial
Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.
Read the detailed description
The use of seton as a surgical therapy for fistulous disease has been first described by Hippocrates in 430 BCE. Since then several authors have used either cutting or drainage seton to treat CAF. Different materials have been used as seton, including sutures, stainless steel wires, catheters, cables, silicone, and rubber bands. While the main aim of a drainage seton is to simply drain sepsis and control symptoms in the long term, cutting setons are mainly used for eradiation of the fistula pathology by cutting through the fistula tract and anal sphincter muscles, yet at the cost of an increased risk of fecal incontinence (FI).
As the purpose of a drainage seton is to provide long-term, durable drainage of perineal sepsis and control of symptoms, namely discharge, the seton material can have an impact on its function and durability. A review of the variations in seton types and materials showed that the success rates of suture seton (silk, prolene or nylon suture) are higher than those of Penrose drains and catheters. However, there is a paucity of data on the impact of the seton material on the durability of seton and quality of life (QoL)
Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability, and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.
- Conditions
- Anal Fistula
- Being tested
- Ethibond suture, Vessel loop
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethibond sutureProcedure or surgery
An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula
Vessel loopProcedure or surgery
A vessel loop will be placed as a drainage seton for complex anal fistula
| Study group | Role | What they receive |
|---|---|---|
| Ethibond suture | Active comparator | Patients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton Receives: Procedure: Ethibond suture |
| Vessel loop | Active comparator | Patients with complex anal fistula will undergo placement of vessel loop as a drainage seton Receives: Procedure: Vessel loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage of perianal sepsis
Change in the perianal disease activity index
Measured: 3 and 12 months
Durability
Incidence and timing of seton break/fall
Measured: within 12 months
Secondary outcomes (3)
Quality of life score
Change in the anal fistula quality of life score which ranges from 14 to 70 and higher values imply greater impact on quality of life
Measured: 3 and 12 months
Healing
Complete healing of the anal fistula evidenced by absence of external opening and discharge
Measured: 12 months
Continence state
Change in the Wexner incontinence score which ranges from 0 to 20 and higher values imply more severe fecal incontinence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start10 Dec 2023
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Why it stopped: Unable to recruit the required number of patients as per the sample size calculated
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.
- More trials run by The Cleveland ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rizkalla, Sameh M.D., The Cleveland Clinic
- Investigators
- Steven D Wexner, M.D., Study chair, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933343
- Sponsor's protocol ID
- CCF06282023
- Status last verified
- Oct 2025
- First submitted
- 28 Jun 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethibond Suture Compared to Vessel Loop as Draining Seton for Complex Anal Fistulas; a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05933343
- Acronym / sponsor ID
- CCF06282023
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit the required number of patients as per the sample size calculated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 6 Jul 2023 (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.
Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.
Detailed description
The use of seton as a surgical therapy for fistulous disease has been first described by Hippocrates in 430 BCE. Since then several authors have used either cutting or drainage seton to treat CAF. Different materials have been used as seton, including sutures, stainless steel wires, catheters, cables, silicone, and rubber bands. While the main aim of a drainage seton is to simply drain sepsis and control symptoms in the long term, cutting setons are mainly used for eradiation of the fistula pathology by cutting through the fistula tract and anal sphincter muscles, yet at the cost of an increased risk of fecal incontinence (FI).
As the purpose of a drainage seton is to provide long-term, durable drainage of perineal sepsis and control of symptoms, namely discharge, the seton material can have an impact on its function and durability. A review of the variations in seton types and materials showed that the success rates of suture seton (silk, prolene or nylon suture) are higher than those of Penrose drains and catheters. However, there is a paucity of data on the impact of the seton material on the durability of seton and quality of life (QoL)
Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability, and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethibond suture | Active comparator | Procedure: Ethibond suturePatients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton |
| Vessel loop | Active comparator | Procedure: Vessel loopPatients with complex anal fistula will undergo placement of vessel loop as a drainage seton |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 18 years or older of either sex who present with CAF will be included. Both cryptoglandular fistulas and fistulas secondary to inflammatory bowel disease (IBD)
Key exclusion criteria (4 listed)
- Simple anal fistulas
- Fistulas secondary to malignancy or irradiation therapy
- Pregnant women
- Patients with pre-existing setons
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 |
|---|---|---|
| Ethibond sutureAn Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula | Procedure or surgery | Ethibond suture |
| Vessel loopA vessel loop will be placed as a drainage seton for complex anal fistula | Procedure or surgery | Vessel loop |
Primary outcome
Drainage of perianal sepsis
Time frame: 3 and 12 months
Change in the perianal disease activity index
Durability
Time frame: within 12 months
Incidence and timing of seton break/fall
3 secondary outcomes
Quality of life score
Time frame: 3 and 12 months
Healing
Time frame: 12 months
Continence state
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Unable to recruit the required number of patients as per the sample size calculated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Anal Fistula
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Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
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The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
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A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
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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.
Steven D Wexner, M.D. study chair
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethibond suture and Vessel loop in people with Anal Fistula, run by The Cleveland Clinic at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 20 Oct 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 United States. 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 was stopped early (reason given: Unable to recruit the required number of patients as per the sample size calculated). Results are not available in the source record.
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?
Drainage of perianal sepsis (time frame: 3 and 12 months). The study lists 2 primary outcomes in all. 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 20 Oct 2025.