Aspiration Treatment of Perianal Abscess
Primary Purpose
Anal Fistulas
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MEDIPLAST® (aspiration)
incision
Clindamycin
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistulas
Eligibility Criteria
Inclusion Criteria:
- ≥18 yrs old
- Perianal abscess (without spontaneous rupture)
- Abscess larger than 2 cm in diameter
- Signed informed consent
Exclusion Criteria:
- Malignancy within 5 yrs
- Previous radiotherapy of the abdomen and pelvis
- Recurrent abscess within 6 months
- Immune suppressed patients
- Pregnant and lactating women
- Abscess with horseshoe formation
- Allergy to Clindamycin
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aspiration
incision
Arm Description
Aspiration of perianal abscess(MEDIPLAST® 13 G, 2,5 x 110 mm) under general anesthesia followed by antibiotic treatment with Clindamycin tablet 300 mg 3 times daily for 7 days
Surgical incision of perianal abscess under general anesthesia.
Outcomes
Primary Outcome Measures
Change in recurrence rate
Rate of recurrences of abscesses in each arm after 2,12 and 52 weeks
Secondary Outcome Measures
changes in Quality of life score
Changes in Short Form Health Survey (SF-36) questionaire after 2,12 and 52 weeks
fecal incontinence
changes in Wexner fecal incontinence score after 2,12 and 52 weeks
Risk factors for fistula formation and abscess recurrence
risk factors for recurrences and fistula formation as; age, gender, BMI, smoking and alcohol use. Furthermore presence or absence of the following medical conditions: diabetes mellitus, ischemic cardiac disease, arrhythmia, hypertension, asthma/ COLD, connective tissue disease and renal function impairment. As well as the characteristics of perianal abscess: number of abscesses, localization, distance from anus in cm, largest diameter in cm, length of symptoms and use of antibiotics prior to admission. Finally bacterial culture.Risk factors of developing fistula after both treatments; both medical and abscess related will be analyzed using multivariate analysis.
Changes in healing time
time to recovery and wound healing after both procedures and it will be measured as the number of days between operation and healed wound.
Changes in fistulas formation
rate of fistula formation in each arm after 2,12 and 52 weeks
Full Information
NCT ID
NCT02585141
First Posted
October 15, 2015
Last Updated
November 10, 2020
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02585141
Brief Title
Aspiration Treatment of Perianal Abscess
Official Title
Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.
Detailed Description
Anorectal abscess is a common condition, caused by cryptoglandular polymicrobial infection, where the traditional treatment is surgical drainage. Anorectal abscess is associated with recurrence rates between 6-44 % after surgical drainage and persistent subsequent fistula up to 37 %. Inadequate incision, missed abscess components or fistulas can be the cause of recurrence . Surgical drainage is associated with discomfort from prolonged wound healing, affecting the daily activities as well as the potential risk of complicated scaring and fecal incontinence. Less invasive method with pus aspiration under antibiotic cover has been shown to be safe in terms of recurrence rate and subsequent fistula formation and well tolerated by the patients with less morbidity and wound complications and a potential lower risk of fecal incontinence. However, this has been shown only in few studies with small population and no randomized controlled study comparing the two approaches has been conducted or published to our knowledge. The risk factors of recurrence and subsequent fistula formation are not that clear but age below 40 years, absence of diabetes mellitus and recent smoking are shown to be risk factors for developing recurrent abscess and fistula. Applying aspiration and antibiotics method for the treatment of perianal abscess can be an advantage for the society due to a shorter recovering period, quicker return to daily activity and work and avoiding wound healing problems and sphincter damage; thus lower expenses. The results of this study have the potentials to reveal the risk factors of developing fistula after perianal abscess.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistulas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aspiration
Arm Type
Experimental
Arm Description
Aspiration of perianal abscess(MEDIPLAST® 13 G, 2,5 x 110 mm) under general anesthesia followed by antibiotic treatment with Clindamycin tablet 300 mg 3 times daily for 7 days
Arm Title
incision
Arm Type
Active Comparator
Arm Description
Surgical incision of perianal abscess under general anesthesia.
Intervention Type
Device
Intervention Name(s)
MEDIPLAST® (aspiration)
Intervention Description
The aspiration drainage will be with a large caliber needle (MEDIPLAST® 13 G, 2,5 x 110 mm) and a syringe of 20 ml. The cavity must be emptied for pus and irrigated by repeated injection and aspiration of saline until clear fluid is obtained.
Intervention Type
Procedure
Intervention Name(s)
incision
Intervention Description
Incision drainage will be undertaken as standardized de-roofing of the abscess and debridement. Wound packing and dressing will not be used, just sitz bath or ordinary hygiene until wound healing.
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Other Intervention Name(s)
postoperative antibiotic
Intervention Description
Postoperative broad spectrum oral antibiotics covering both aerobes and anaerobes bacteria will be given for seven days of Clindamycin 300 mg tablets x 3 a day
Primary Outcome Measure Information:
Title
Change in recurrence rate
Description
Rate of recurrences of abscesses in each arm after 2,12 and 52 weeks
Time Frame
2,12 and 52 weeks
Secondary Outcome Measure Information:
Title
changes in Quality of life score
Description
Changes in Short Form Health Survey (SF-36) questionaire after 2,12 and 52 weeks
Time Frame
2,12 and 52 weeks
Title
fecal incontinence
Description
changes in Wexner fecal incontinence score after 2,12 and 52 weeks
Time Frame
2,12 and 52 weeks
Title
Risk factors for fistula formation and abscess recurrence
Description
risk factors for recurrences and fistula formation as; age, gender, BMI, smoking and alcohol use. Furthermore presence or absence of the following medical conditions: diabetes mellitus, ischemic cardiac disease, arrhythmia, hypertension, asthma/ COLD, connective tissue disease and renal function impairment. As well as the characteristics of perianal abscess: number of abscesses, localization, distance from anus in cm, largest diameter in cm, length of symptoms and use of antibiotics prior to admission. Finally bacterial culture.Risk factors of developing fistula after both treatments; both medical and abscess related will be analyzed using multivariate analysis.
Time Frame
2,12 and 52 weeks
Title
Changes in healing time
Description
time to recovery and wound healing after both procedures and it will be measured as the number of days between operation and healed wound.
Time Frame
2,12 and 52 weeks
Title
Changes in fistulas formation
Description
rate of fistula formation in each arm after 2,12 and 52 weeks
Time Frame
2,12 and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 yrs old
Perianal abscess (without spontaneous rupture)
Abscess larger than 2 cm in diameter
Signed informed consent
Exclusion Criteria:
Malignancy within 5 yrs
Previous radiotherapy of the abdomen and pelvis
Recurrent abscess within 6 months
Immune suppressed patients
Pregnant and lactating women
Abscess with horseshoe formation
Allergy to Clindamycin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karam M Sørensen
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
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Links:
URL
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Aspiration Treatment of Perianal Abscess
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