Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Primary Purpose
Perianal Abscess, Anal Fistulas, Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Perianal abscess drainage
3D ultrasonography
Sponsored by
About this trial
This is an interventional treatment trial for Perianal Abscess focused on measuring endoanal ultrasonography, drainage, perianal abscess, fistulas, incontience
Eligibility Criteria
Inclusion Criteria:
- perianal abscess that needs surgical treatment, over the age of 18
Exclusion Criteria:
- Under the age of 18 or unable to understand study information because of language difficulties or dementia.
Sites / Locations
- Department of SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ultrasonography, abscess
Control group with clincial inscision
Arm Description
The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.
The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02306382
First Posted
December 13, 2012
Last Updated
May 17, 2022
Sponsor
University Hospital, Umeå
1. Study Identification
Unique Protocol Identification Number
NCT02306382
Brief Title
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Official Title
Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Umeå
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Abscess, Anal Fistulas, Incontinence
Keywords
endoanal ultrasonography, drainage, perianal abscess, fistulas, incontience
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ultrasonography, abscess
Arm Type
Experimental
Arm Description
The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.
Arm Title
Control group with clincial inscision
Arm Type
Other
Arm Description
The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year.
Intervention Type
Procedure
Intervention Name(s)
Perianal abscess drainage
Other Intervention Name(s)
1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
3D ultrasonography
Other Intervention Name(s)
2
Intervention Description
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.
Primary Outcome Measure Information:
Title
adverse events
Description
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.
Time Frame
up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
perianal abscess that needs surgical treatment, over the age of 18
Exclusion Criteria:
Under the age of 18 or unable to understand study information because of language difficulties or dementia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Strigård, MD
Phone
+46 785 5000
Email
karin.strigard@surgery.umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf Gunnarsson, MD
Phone
+46 8 5177 0000
Email
ulf.gunnarsson@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Gustafsson, MD
Organizational Affiliation
University Hospital, Umeå
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin Strigård Strigård, MD
Organizational Affiliation
University Hospital, Umeå
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ulf Gunnarsson, MD
Organizational Affiliation
University Hospital, Umeå
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery
City
Umea
State/Province
County Of Vasterbotten §
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Gustafsson, MD
Phone
+46 70 3364755
Email
karingustafsson@ymail.com
First Name & Middle Initial & Last Name & Degree
Karin Strigård, MD
12. IPD Sharing Statement
Learn more about this trial
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
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