Clinical trial NCT05933343: Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas
Official title: Ethibond Suture Compared to Vessel Loop as Draining Seton for Complex Anal Fistulas; a Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anal Fistula
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Drainage of perianal sepsis
timeFrame: 3 and 12 months
measure: Durability
timeFrame: within 12 months
Secondary outcomes:
measure: Quality of life score
timeFrame: 3 and 12 months
measure: Healing
timeFrame: 12 months
measure: Continence state
timeFrame: 12 months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Steven D Wexner, M.D.
role: STUDY_CHAIR
References: