Aspiration Treatment of Perianal Abscess

Anal Fistulas Clinical Trial

Official title:

Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585141
• Other study ID #: S-20140191
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 yrs old

2. Perianal abscess (without spontaneous rupture)

3. Abscess larger than 2 cm in diameter

4. Signed informed consent

Exclusion Criteria:

1. Malignancy within 5 yrs

2. Previous radiotherapy of the abdomen and pelvis

3. Recurrent abscess within 6 months

4. Immune suppressed patients

5. Pregnant and lactating women

6. Abscess with horseshoe formation

7. Allergy to Clindamycin

Related Conditions & MeSH terms

• Anal Fistulas
• Fistula
• Rectal Fistula

Intervention

Device:
• MEDIPLAST® (aspiration)
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.

Procedure:
• incision
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.

Drug:
• Clindamycin
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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (19)

Beck DE, Fazio VW, Lavery IC, Jagelman DG, Weakley FL. Catheter drainage of ischiorectal abscesses. South Med J. 1988 Apr;81(4):444-6. — View Citation

Chrabot CM, Prasad ML, Abcarian H. Recurrent anorectal abscesses. Dis Colon Rectum. 1983 Feb;26(2):105-8. — View Citation

Cox SW, Senagore AJ, Luchtefeld MA, Mazier WP. Outcome after incision and drainage with fistulotomy for ischiorectal abscess. Am Surg. 1997 Aug;63(8):686-9. — View Citation

Devaraj B, Khabassi S, Cosman BC. Recent smoking is a risk factor for anal abscess and fistula. Dis Colon Rectum. 2011 Jun;54(6):681-5. doi: 10.1007/DCR.0b013e31820e7c7a. — View Citation

Hamadani A, Haigh PI, Liu IL, Abbas MA. Who is at risk for developing chronic anal fistula or recurrent anal sepsis after initial perianal abscess? Dis Colon Rectum. 2009 Feb;52(2):217-21. doi: 10.1007/DCR.0b013e31819a5c52. — View Citation

Hämäläinen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2. — View Citation

Isbister WH. A simple method for the management of anorectal abscess. Aust N Z J Surg. 1987 Oct;57(10):771-4. — View Citation

Kovalcik PJ, Peniston RL, Cross GH. Anorectal abscess. Surg Gynecol Obstet. 1979 Dec;149(6):884-6. — View Citation

Kronborg O, Olsen H. Incision and drainage v. incision, curettage and suture under antibiotic cover in anorectal abscess. A randomized study with 3-year follow-up. Acta Chir Scand. 1984;150(8):689-92. — View Citation

Kyle S, Isbister WH. Management of anorectal abscesses: comparison between traditional incision and packing and de Pezzer catheter drainage. Aust N Z J Surg. 1990 Feb;60(2):129-31. — View Citation

Lohsiriwat V, Yodying H, Lohsiriwat D. Incidence and factors influencing the development of fistula-in-ano after incision and drainage of perianal abscesses. J Med Assoc Thai. 2010 Jan;93(1):61-5. — View Citation

Malik AI, Nelson RL, Tou S. Incision and drainage of perianal abscess with or without treatment of anal fistula. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD006827. doi: 10.1002/14651858.CD006827.pub2. Review. — View Citation

Marcus RH, Stine RJ, Cohen MA. Perirectal abscess. Ann Emerg Med. 1995 May;25(5):597-603. — View Citation

Mortensen J, Kraglund K, Klaerke M, Jaeger G, Svane S, Boné J. Primary suture of anorectal abscess. A randomized study comparing treatment with clindamycin vs. clindamycin and Gentacoll. Dis Colon Rectum. 1995 Apr;38(4):398-401. — View Citation

Read DR, Abcarian H. A prospective survey of 474 patients with anorectal abscess. Dis Colon Rectum. 1979 Nov-Dec;22(8):566-8. — View Citation

Rickard MJ. Anal abscesses and fistulas. ANZ J Surg. 2005 Jan-Feb;75(1-2):64-72. Review. — View Citation

Smieja M. Current indications for the use of clindamycin: A critical review. Can J Infect Dis. 1998 Jan;9(1):22-8. — View Citation

Stevens DL, Bisno AL, Chambers HF, Everett ED, Dellinger P, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan EL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. Epub 2005 Oct 14. Erratum in: Clin Infect Dis. 2005 Dec 15;41(12):1830. Clin Infect Dis. 2006 Apr 15;42(8):1219. Dosage error in article text. — View Citation

Vasilevsky CA, Gordon PH. The incidence of recurrent abscesses or fistula-in-ano following anorectal suppuration. Dis Colon Rectum. 1984 Feb;27(2):126-30. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in recurrence rate	Rate of recurrences of abscesses in each arm after 2,12 and 52 weeks	2,12 and 52 weeks
Secondary	changes in Quality of life score	Changes in Short Form Health Survey (SF-36) questionaire after 2,12 and 52 weeks	2,12 and 52 weeks
Secondary	fecal incontinence	changes in Wexner fecal incontinence score after 2,12 and 52 weeks	2,12 and 52 weeks
Secondary	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.	2,12 and 52 weeks
Secondary	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.	2,12 and 52 weeks
Secondary	Changes in fistulas formation	rate of fistula formation in each arm after 2,12 and 52 weeks	2,12 and 52 weeks

External Links

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