Anal Fistula Plug, a Retrospective Study

NCT ID: NCT04319861

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-01
• Study Completion Date: 2019-01-31

Brief Summary

In this study, we retrospectively reviewed clinical data of patients who were treated with an anal fistula plug for trans-sphincteric anal fistulas, and evaluated the long-term therapeutic effect of an anal fistula plug and the risk factors impacting anal fistula healing. In addition, we assessed the effects of post-operative changes on anal function, as well as the risk factors affecting anal function.

Detailed Description

Treatment of anal fistulas, especially involving significant anal sphincters, continues to represent a challenge for surgeons. Surgery has been the mainstay of treatment, and the ideal goal of anal fistula treatment is to obliterate the fistulous tract, while preserving the anal sphincter and avoiding fecal incontinence. The anal fistula plug is a sphincter-sparing procedure that uses biological substances to close an anorectal fistula. Several studies have preliminarily shown that the anal fistula plug had advantages of simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and subsequent surgical options if needed. The healing rate of anal fistula plug varied widely, which range from 14% to 88%, and no significant effect on anal function in the short term. Therefore, long-term observation and a large sample size are needed to evaluate the long-term healing rate of an anal fistula plug, and the effect on anal function. The aim of this study is to assess the long-term therapeutic effect of an anal fistula plug in patients with trans-sphincteric fistula-in-ano, as well as the impact on anal function.

Conditions

Healing Rate; Recurrence; Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anal fistula plug

The anal fistula plug procedure was performed as followings. A fistula probe was used to identify fistula tracts, and internal and external openings. Gentle mechanical debridement was performed with a blunt curette to remove the necrotic tissue with care not to enlarge the track, then hydrogen peroxide and sterile saline were used to repeatedly to irrigate the fistula. The anal fistutla plug was filled into the fistula, and sutured with a figure-of-eight 2-to-0 Vicryl suture to ensure the plug was fixed in the internal opening of the fistula, avoiding the anal fistula plug being extruded. Trimming the plug at the external fistula and the external opening was left open to ensure adequate drainage.

Group Type: EXPERIMENTAL

Anal fistula plug procedure

Intervention Type: PROCEDURE

A fistula probe was used to identify fistula tracts, and internal and external openings. Gentle mechanical debridement was performed with a blunt curette to remove the necrotic tissue with care not to enlarge the track, then hydrogen peroxide and sterile saline were used to repeatedly to irrigate the fistula. The anal fistutla plug was filled into the fistula, and sutured with a figure-of-eight 2-to-0 Vicryl suture to ensure the plug was fixed in the internal opening of the fistula, avoiding the anal fistula plug being extruded. Trimming the plug at the external fistula and the external opening was left open to ensure adequate drainage.

Interventions

Anal fistula plug procedure

A fistula probe was used to identify fistula tracts, and internal and external openings. Gentle mechanical debridement was performed with a blunt curette to remove the necrotic tissue with care not to enlarge the track, then hydrogen peroxide and sterile saline were used to repeatedly to irrigate the fistula. The anal fistutla plug was filled into the fistula, and sutured with a figure-of-eight 2-to-0 Vicryl suture to ensure the plug was fixed in the internal opening of the fistula, avoiding the anal fistula plug being extruded. Trimming the plug at the external fistula and the external opening was left open to ensure adequate drainage.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with trans-sphincteric anal fistula.
• The case information was complete.
• Not receive other treatment previously.

Exclusion Criteria

• Fistulas related to Crohn's disease, ulcerative colitis or anorectal tumors.
• Underwent surgical incision and drainage for acute perianal infections within 3 months.
• Multiple fistula tracts > 2.
• Poor underlying condition and unable to tolerate surgery.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhen Jun Wang

OTHER

Sponsor Role: lead

Responsible Party

Zhen Jun Wang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jiagang Han

Role: STUDY_DIRECTOR

Beijing Chao Yang Hospital

Locations

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Plug 2020

Identifier Type: -

Identifier Source: org_study_id