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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933343
• Other study ID #: CCF06282023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: Sameh H Rizkalla, M.D.
• Phone: 5513309230
• Email: rizkals[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 31, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• Ethibond suture
An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula
• Vessel loop
A vessel loop will be placed as a drainage seton for complex anal fistula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drainage of perianal sepsis	Change in the perianal disease activity index	3 and 12 months
Primary	Durability	Incidence and timing of seton break/fall	within 12 months
Secondary	Quality of life score	Change in the anal fistula quality of life score	3 and 12 months
Secondary	Healing	Complete healing of the anal fistula evidenced by absence of external opening and discharge	12 months
Secondary	Continence state	Change in the Wexner incontinence score	12 months