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Anal Fistula Plug, a Retrospective Study

Primary Purpose

Healing Rate, Recurrence, Complication

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anal fistula plug procedure
Sponsored by
Zhen Jun Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healing Rate focused on measuring Anal fistula plug, Trans-sphincteric anal fistula, Overall healing rate, Anal function, Risk factors, Minimally invasive

Eligibility Criteria

15 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chaoyang Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anal fistula plug

Arm Description

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.

Outcomes

Primary Outcome Measures

Healing rate
The healing rate of anal fistula plug in 8 years postoperatively

Secondary Outcome Measures

Anal function
Cleveland Clinic Florida (Wexner) incontinence scale

Full Information

First Posted
March 15, 2020
Last Updated
March 21, 2020
Sponsor
Zhen Jun Wang
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1. Study Identification

Unique Protocol Identification Number
NCT04319861
Brief Title
Anal Fistula Plug, a Retrospective Study
Official Title
Long-term Clinical Results With the Use of an Anal Fistula Plug for the Treatment of Trans-sphincteric Anal Fistulas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2008 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhen Jun Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healing Rate, Recurrence, Complication
Keywords
Anal fistula plug, Trans-sphincteric anal fistula, Overall healing rate, Anal function, Risk factors, Minimally invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anal fistula plug
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Anal fistula plug procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing rate
Description
The healing rate of anal fistula plug in 8 years postoperatively
Time Frame
8 years postoperatively
Secondary Outcome Measure Information:
Title
Anal function
Description
Cleveland Clinic Florida (Wexner) incontinence scale
Time Frame
8 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiagang Han
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Anal Fistula Plug, a Retrospective Study

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