Anal FistulaDADSNCT05044182
Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula
A study testing Decompression and drainage seton and Cutting seton in people with Anal Fistula, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Decompression 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
- 92 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2021to 31 Jan 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from high horseshoe anal fistula
Who cannot join
- Specific cause of fistula e.g. Crohn's disease.
- Previous anorectal surgery.
- Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
- Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan friendship
Beijing, Beijing Municipality, 100029
Hui Li, bachelor, +861084206250, 358219241@qq.com
About this study
Official title: Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula
Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.
- Conditions
- Anal Fistula
- Being tested
- Decompression and drainage seton, Cutting seton
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression 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 |
|---|---|---|
| Decompression and drainage seton | Experimental | Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter. Receives: Procedure: Decompression and drainage seton; Procedure: Cutting seton |
| Cutting seton | Experimental | Cutting seton will be put around the internal and external anal sphincter. Receives: Procedure: Decompression and drainage seton; Procedure: Cutting seton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
recurrence was defined as the clinical reappearance of the fistula after complete healing.
Measured: 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start8 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 92 participants (estimated)
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
- NCT05044182
- Sponsor's protocol ID
- 2020-1-QN-10
- Acronym
- DADS
- Status last verified
- Feb 2023
- First submitted
- 5 Sep 2021
- Last updated
- 16 Feb 2023
- Results posted
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula
- ClinicalTrials.gov ID
- NCT05044182
- Acronym / sponsor ID
- DADS / 2020-1-QN-10
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 14 Sep 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.
Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompression and drainage seton | Experimental | Procedure: Decompression and drainage seton, Procedure: Cutting setonDecompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter. |
| Cutting seton | Experimental | Procedure: Decompression and drainage seton, Procedure: Cutting setonCutting seton will be put around the internal and external anal sphincter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from high horseshoe anal fistula
Key exclusion criteria (4 listed)
- Specific cause of fistula e.g. Crohn's disease.
- Previous anorectal surgery.
- Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
- Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.
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 |
|---|---|---|
| Decompression 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 | Cutting seton, Decompression 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, Decompression and drainage seton |
Primary outcome
Recurrence rate
Time frame: 12 months after the procedure
recurrence was defined as the clinical reappearance of the fistula after complete healing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression and drainage seton and Cutting seton in people with 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 1 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Li, bachelor (0861084206250, 358219241@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 12 months after the procedure). 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 16 Feb 2023.