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Aspiration Treatment of Perianal Abscess

NCT ID: NCT02585141

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Anal Fistulas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aspiration

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

Group Type EXPERIMENTAL

MEDIPLAST® (aspiration)

Intervention Type DEVICE

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.

Clindamycin

Intervention Type DRUG

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

incision

Surgical incision of perianal abscess under general anesthesia.

Group Type ACTIVE_COMPARATOR

incision

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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

Intervention Type DRUG

Other Intervention Names

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postoperative antibiotic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Karam Matlub Sørensen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karam M Sørensen

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Marcus RH, Stine RJ, Cohen MA. Perirectal abscess. Ann Emerg Med. 1995 May;25(5):597-603. doi: 10.1016/s0196-0644(95)70170-2.

Reference Type BACKGROUND
PMID: 7741334 (View on PubMed)

Hamalainen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2. doi: 10.1007/BF02237048.

Reference Type BACKGROUND
PMID: 9823799 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 505265 (View on PubMed)

Read DR, Abcarian H. A prospective survey of 474 patients with anorectal abscess. Dis Colon Rectum. 1979 Nov-Dec;22(8):566-8. doi: 10.1007/BF02587008.

Reference Type BACKGROUND
PMID: 527452 (View on PubMed)

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. doi: 10.1007/BF02553995.

Reference Type BACKGROUND
PMID: 6697831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9247434 (View on PubMed)

Chrabot CM, Prasad ML, Abcarian H. Recurrent anorectal abscesses. Dis Colon Rectum. 1983 Feb;26(2):105-8. doi: 10.1007/BF02562586.

Reference Type BACKGROUND
PMID: 6822168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20614450 (View on PubMed)

Rickard MJ. Anal abscesses and fistulas. ANZ J Surg. 2005 Jan-Feb;75(1-2):64-72. doi: 10.1111/j.1445-2197.2005.03280.x.

Reference Type BACKGROUND
PMID: 15740520 (View on PubMed)

Beck DE, Fazio VW, Lavery IC, Jagelman DG, Weakley FL. Catheter drainage of ischiorectal abscesses. South Med J. 1988 Apr;81(4):444-6. doi: 10.1097/00007611-198804000-00008.

Reference Type BACKGROUND
PMID: 3358166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2327914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6397949 (View on PubMed)

Isbister WH. A simple method for the management of anorectal abscess. Aust N Z J Surg. 1987 Oct;57(10):771-4. doi: 10.1111/j.1445-2197.1987.tb01259.x.

Reference Type BACKGROUND
PMID: 3426451 (View on PubMed)

Mortensen J, Kraglund K, Klaerke M, Jaeger G, Svane S, Bone 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. doi: 10.1007/BF02054229.

Reference Type BACKGROUND
PMID: 7720448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20196412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21552051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19279415 (View on PubMed)

Smieja M. Current indications for the use of clindamycin: A critical review. Can J Infect Dis. 1998 Jan;9(1):22-8. doi: 10.1155/1998/538090.

Reference Type BACKGROUND
PMID: 22346533 (View on PubMed)

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. doi: 10.1086/497143. Epub 2005 Oct 14. No abstract available.

Reference Type BACKGROUND
PMID: 16231249 (View on PubMed)

Sorensen KM, Moller S, Qvist N. Needle aspiration treatment vs. incision of acute simple perianal abscess: randomized controlled study. Int J Colorectal Dis. 2021 Mar;36(3):581-588. doi: 10.1007/s00384-021-03845-6. Epub 2021 Jan 15.

Reference Type DERIVED
PMID: 33447866 (View on PubMed)

Related Links

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http://open.rsyd.dk/OpenProjects/da/openProject.jsp?openNo=145

OPEN homepage. OPEN hosts all projects data.

Other Identifiers

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S-20140191

Identifier Type: -

Identifier Source: org_study_id