Clinical trial NCT04319861: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healing Rate
Recurrence
Complication
Keywords: Anal fistula plug
Trans-sphincteric anal fistula
Overall healing rate
Anal function
Risk factors
Minimally invasive
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 207
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Healing rate
timeFrame: 8 years postoperatively
Secondary outcomes:
measure: Anal function
timeFrame: 8 years postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Jiagang Han
role: STUDY_DIRECTOR
References: