Healing RateNCT04319861
Anal Fistula Plug, a Retrospective Study
A study testing Anal fistula plug procedure in people with Healing Rate and Recurrence, run by Zhen Jun Wang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 to 69 years
- Conditions the study is for
- Healing Rate, Recurrence, Complication
- What is being tested?
- Anal fistula plug procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2008to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with trans-sphincteric anal fistula.
- The case information was complete.
- Not receive other treatment previously.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
Official title: Long-term Clinical Results With the Use of an Anal Fistula Plug for the Treatment of Trans-sphincteric Anal Fistulas
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.
Read the 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.
- Conditions
- Healing Rate, Recurrence, Complication
- Being tested
- Anal fistula plug procedure
- Keywords
- Anal fistula plug, Trans-sphincteric anal fistula, Overall healing rate, Anal function, Risk factors, Minimally invasive
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal fistula plug procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Anal fistula plug | Experimental | 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. Receives: Procedure: Anal fistula plug procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
The healing rate of anal fistula plug in 8 years postoperatively
Measured: 8 years postoperatively
Secondary outcomes (1)
Anal function
Cleveland Clinic Florida (Wexner) incontinence scale
Measured: 8 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Aug 2008
- Primary completion20 Nov 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhen Jun Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Jiagang Han, Study director, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319861
- Sponsor's protocol ID
- Plug 2020
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Results With the Use of an Anal Fistula Plug for the Treatment of Trans-sphincteric Anal Fistulas
- ClinicalTrials.gov ID
- NCT04319861
- Acronym / sponsor ID
- Plug 2020
- Conditions
- Healing Rate, Recurrence, Complication
- Keywords
- Anal fistula plug, Trans-sphincteric anal fistula, Overall healing rate, Anal function, Risk factors, Minimally invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Zhen Jun WangUniversity, hospital or other
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal fistula plug | Experimental | Procedure: Anal fistula plug procedureThe 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. |
Who may qualify
- Ages
- 15 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with trans-sphincteric anal fistula.
- The case information was complete.
- Not receive other treatment previously.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal fistula plug procedureA 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 or surgery | Anal fistula plug |
Primary outcome
Healing rate
Time frame: 8 years postoperatively
The healing rate of anal fistula plug in 8 years postoperatively
1 secondary outcome
Anal function
Time frame: 8 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiagang Han study director
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anal fistula plug procedure in people with Healing Rate and Recurrence, run by Zhen Jun Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: 8 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.