Anal Fistula Plug, a Retrospective Study

NCT04319861 | Completed

• 1 other identifier: Plug 2020
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Rate; Recurrence; Complication

Keywords

Anal fistula plug; Trans-sphincteric anal fistula; Overall healing rate; Anal function; Risk factors; Minimally invasive

Outcome Measures

Primary Outcomes (1)

• Healing rate

  The healing rate of anal fistula plug in 8 years postoperatively

  8 years postoperatively

Secondary Outcomes (1)

• Anal function

  8 years postoperatively

Study Arms (1)

Anal fistula plug

EXPERIMENTAL

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.

Procedure: Anal fistula plug procedure

Interventions

Anal fistula plug procedure 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.

Anal fistula plug

Eligibility Criteria

• Age: 15 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhen Jun Wang: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiagang Han

  Beijing Chao Yang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 24, 2020
• Study Start: August 1, 2008
• Primary Completion: November 20, 2018
• Study Completion: January 31, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)