Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ethibond Suture Compared to Vessel Loop as Draining Seton for Complex Anal Fistulas; a Multicenter Randomized Clinical Trial

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: Ethibond suture
* Procedure: Vessel loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Simple anal fistulas Fistulas secondary to malignancy or irradiation therapy Pregnant women Patients with pre-existing setons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ethibond suture<br>Patients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton | Procedure: Ethibond suture<br>* An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula<br>|
| Active Comparator: Vessel loop<br>Patients with complex anal fistula will undergo placement of vessel loop as a drainage seton | Procedure: Vessel loop<br>* A vessel loop will be placed as a drainage seton for complex anal fistula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drainage of perianal sepsis | Change in the perianal disease activity index | 3 and 12 months | 
| Durability | Incidence and timing of seton break/fall | within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | Change in the anal fistula quality of life score | 3 and 12 months | 
| Healing | Complete healing of the anal fistula evidenced by absence of external opening and discharge | 12 months | 
| Continence state | Change in the Wexner incontinence score | 12 months |