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

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.

Study Overview

• Status: Terminated
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: Ethibond suture; Procedure: Vessel loop

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Healing	Complete healing of the anal fistula evidenced by absence of external opening and discharge	12 months
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	3 and 12 months
Continence state	Change in the Wexner incontinence score which ranges from 0 to 20 and higher values imply more severe fecal incontinence	12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Chair: Steven D Wexner, M.D., Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): October 16, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Fistula; Intestinal Fistula; Pathological Conditions, Signs and Symptoms; Rectal Fistula
• Other Study ID Numbers: CCF06282023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No