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NCT Number: NCT04319861

Anal Fistula Plug, a Retrospective Study

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.

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Key information

Conditions

Healing Rate Complication Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

15 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Healing rate

    Time frame: 8 years postoperatively

    The healing rate of anal fistula plug in 8 years postoperatively

Secondary outcomes

  1. Anal function

    Time frame: 8 years postoperatively

    Cleveland Clinic Florida (Wexner) incontinence scale

Sponsors and collaborators

Lead sponsor

Zhen Jun Wang

Other

Registry information

Official study title

Long-term Clinical Results With the Use of an Anal Fistula Plug for the Treatment of Trans-sphincteric Anal Fistulas

Important dates

Study start
2008
Primary completion
2018
Study completion
2019
First posted
Mar 24, 2020
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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