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Anal Fistula Plug, a Retrospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319861
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Healing Rate Recurrence Complication Procedure: Anal fistula plug procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Clinical Results With the Use of an Anal Fistula Plug for the Treatment of Trans-sphincteric Anal Fistulas
Actual Study Start Date : August 1, 2008
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.




Primary Outcome Measures :
  1. Healing rate [ Time Frame: 8 years postoperatively ]
    The healing rate of anal fistula plug in 8 years postoperatively


Secondary Outcome Measures :
  1. Anal function [ Time Frame: 8 years postoperatively ]
    Cleveland Clinic Florida (Wexner) incontinence scale



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319861


Locations
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China, Beijing
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing, China, 100020
Sponsors and Collaborators
Zhen Jun Wang
Investigators
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Study Director: Jiagang Han Beijing Chao Yang Hospital
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Responsible Party: Zhen Jun Wang, Professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04319861    
Other Study ID Numbers: Plug 2020
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhen Jun Wang, Beijing Chao Yang Hospital:
Anal fistula plug
Trans-sphincteric anal fistula
Overall healing rate
Anal function
Risk factors
Minimally invasive
Additional relevant MeSH terms:
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Rectal Fistula
Recurrence
Fistula
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases