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

NCT ID: NCT05933343

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2025-10-16

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.

Conditions

Anal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ethibond suture

Patients with complex anal fistula will undergo placement of Ethibond™ 1 suture as a drainage seton

Group Type: ACTIVE_COMPARATOR

Ethibond suture

Intervention Type: PROCEDURE

An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula

Vessel loop

Patients with complex anal fistula will undergo placement of vessel loop as a drainage seton

Group Type: ACTIVE_COMPARATOR

Vessel loop

Intervention Type: PROCEDURE

A vessel loop will be placed as a drainage seton for complex anal fistula

Interventions

Ethibond suture

An Ethibond™ 1 suture will be placed as a drainage seton for complex anal fistula

Intervention Type: PROCEDURE

Vessel loop

A vessel loop will be placed as a drainage seton for complex anal fistula

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rizkalla, Sameh M.D.

Project Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven D Wexner, M.D.

Role: STUDY_CHAIR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Other Identifiers

CCF06282023

Identifier Type: -

Identifier Source: org_study_id