Perianal AbscessNCT02306382
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
A study testing Perianal abscess drainage and 3D ultrasonography in people with Perianal Abscess and Anal Fistulas, run by University Hospital, Umeå at 1 site in Sweden.
Trial summary
Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Abscess, Anal Fistulas, Incontinence
- What is being tested?
- Perianal abscess drainage and 3D ultrasonography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2012to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- perianal abscess that needs surgical treatment, over the age of 18
Who cannot join
- Under the age of 18 or unable to understand study information because of language difficulties or dementia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Surgery
Umeå, County of Vasterbotten §, 901 85
Karin Gustafsson, MD, +46 70 3364755, karingustafsson@ymail.com
Karin Strigård, MD
About this study
Official title: Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.
Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence.
Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal.
The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.
Read the detailed description
The individual patient is informed about the condition and if meets criteria is offered to take part in the study. Written information and informed consent always noted. Questions about the patients general medical condition is noted and if the person has had problems with perianal abscesses before.
- Conditions
- Perianal Abscess, Anal Fistulas, Incontinence
- Being tested
- Perianal abscess drainage, 3D ultrasonography
- Keywords
- endoanal ultrasonography, drainage, perianal abscess, fistulas, incontience
- Medical subject headings
- Rectal Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perianal abscess drainageProcedure or surgery
Also called 1
The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained.
3D ultrasonographyDevice
Also called 2
The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained.
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography, abscess | Experimental | The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year. Receives: Procedure: Perianal abscess drainage; Device: 3D ultrasonography |
| Control group with clincial inscision | Other | The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year. Receives: Procedure: Perianal abscess drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Patients will be assessed in the outpatient clinic after 2 months and 1 year after surgical treatment. Eventual complications may include anal sepsis, recurrence of anal abscess and fistula formation.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal AbscessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Umeå
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Gustafsson, University Hospital, Umeå
- Investigators
- Karin Gustafsson, MD, Principal investigator, University Hospital, UmeåKarin Strigård Strigård, MD, Study director, University Hospital, UmeåUlf Gunnarsson, MD, Study chair, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306382
- Sponsor's protocol ID
- 1-Gustafsson
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2012
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.
- ClinicalTrials.gov ID
- NCT02306382
- Acronym / sponsor ID
- 1-Gustafsson
- Conditions
- Perianal Abscess, Anal Fistulas, Incontinence
- Keywords
- endoanal ultrasonography, drainage, perianal abscess, fistulas, incontience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, UmeåUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- 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.
Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence.
Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal.
The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.
Detailed description
The individual patient is informed about the condition and if meets criteria is offered to take part in the study. Written information and informed consent always noted. Questions about the patients general medical condition is noted and if the person has had problems with perianal abscesses before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonography, abscess | Experimental | Procedure: Perianal abscess drainage, Device: 3D ultrasonographyThe experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year. |
| Control group with clincial inscision | Other | Procedure: Perianal abscess drainageThe control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- perianal abscess that needs surgical treatment, over the age of 18
Key exclusion criteria (1 listed)
- Under the age of 18 or unable to understand study information because of language difficulties or dementia.
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 |
|---|---|---|
| Perianal abscess drainageAlso: 1The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained. | Procedure or surgery | Control group with clincial inscision, ultrasonography, abscess |
| 3D ultrasonographyAlso: 2The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained. | Device | ultrasonography, abscess |
Primary outcome
adverse events
Time frame: up to one year
Patients will be assessed in the outpatient clinic after 2 months and 1 year after surgical treatment. Eventual complications may include anal sepsis, recurrence of anal abscess and fistula formation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
Karin Gustafsson, MD principal investigator
University Hospital, Umeå
Karin Strigård Strigård, MD study director
University Hospital, Umeå
Ulf Gunnarsson, MD study chair
University Hospital, Umeå
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perianal abscess drainage and 3D ultrasonography in people with Perianal Abscess and Anal Fistulas, run by University Hospital, Umeå at 1 site in Sweden.
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 1 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: looking for participants now, as of the sponsor's last update on 29 Nov 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Strigård, MD (+46 785 5000, karin.strigard@surgery.umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: up to one year). 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 29 Nov 2023.