High Complex Anal FistulaNCT05087407
Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
A study testing Decomprssion and drainage seton and Cutting seton in people with High Complex Anal Fistula, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- High Complex Anal Fistula
- What is being tested?
- Decomprssion and drainage seton and Cutting seton
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 May 2020
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
- suprasphincteric fistulas were enrolled
Who cannot join
- Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
- Patients with symptoms of fecal incontinence;
- A previous history of anal fistula surgical treatment;
- Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.
- Conditions
- High Complex Anal Fistula
- Being tested
- Decomprssion and drainage seton, Cutting seton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decomprssion and drainage setonProcedure or surgery
Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
Cutting setonProcedure or surgery
Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
| Study group | Role | What they receive |
|---|---|---|
| decomprssion and drainage seton | Experimental | Not described Receives: Procedure: Decomprssion and drainage seton |
| Cutting seton | Active comparator | Not described Receives: Procedure: Cutting seton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healing
complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination.
Measured: 6 months post-operation.
Recurrence rate
recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton
Measured: within 12 months after the procedure
The healing time of the anal wound (days)
the time needed to achieve complete healing of anal fistula.
Measured: 6 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Dec 2016
- Primary completion1 Dec 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Complex Anal FistulaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Li, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087407
- Sponsor's protocol ID
- No.2016-81
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 28 Oct 2021
- 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 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
- ClinicalTrials.gov ID
- NCT05087407
- Acronym / sponsor ID
- No.2016-81
- Conditions
- High Complex Anal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 21 Oct 2021 (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.
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decomprssion and drainage seton | Experimental | Procedure: Decomprssion and drainage seton |
| Cutting seton | Active comparator | Procedure: Cutting seton |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
- suprasphincteric fistulas were enrolled
Key exclusion criteria (4 listed)
- Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
- Patients with symptoms of fecal incontinence;
- A previous history of anal fistula surgical treatment;
- Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
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 |
|---|---|---|
| Decomprssion and drainage setonIncision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter. | Procedure or surgery | decomprssion and drainage seton |
| Cutting setonCutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter. | Procedure or surgery | Cutting seton |
Primary outcome
Rate of healing
Time frame: 6 months post-operation.
complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination.
Recurrence rate
Time frame: within 12 months after the procedure
recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton
The healing time of the anal wound (days)
Time frame: 6 months post-operation.
the time needed to achieve complete healing of anal fistula.
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 28 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for High Complex Anal Fistula
Active, not recruiting
This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.
Perianal Fistula
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decomprssion and drainage seton and Cutting seton in people with High Complex Anal Fistula, run by China-Japan Friendship Hospital 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 2 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 28 Oct 2021. 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?
Rate of healing (time frame: 6 months post-operation.). The study lists 3 primary outcomes in all. 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 28 Oct 2021.