Anal Fistula Plug, a Retrospective Study

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319861
• Other study ID #: Plug 2020
• Status: Completed
• Phase: N/A
• Start date: August 1, 2008
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2020
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 31, 2019
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Fistula
• Healing Rate
• Rectal Fistula
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhen Jun Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate	The healing rate of anal fistula plug in 8 years postoperatively	8 years postoperatively
Secondary	Anal function	Cleveland Clinic Florida (Wexner) incontinence scale	8 years postoperatively