Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

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.

Study Overview

• Status: Recruiting
• Conditions: Perianal Abscess; Incontinence; Anal Fistulas
• Intervention / Treatment: Procedure: Perianal abscess drainage; Device: 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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Strigård, MD; Phone Number: +46 785 5000; Email: karin.strigard@surgery.umu.se
• Study Contact Backup: Name: Ulf Gunnarsson, MD; Phone Number: +46 8 5177 0000; Email: ulf.gunnarsson@ki.se

Study Locations

• Sweden
  • County Of Vasterbotten §
    • Umea, County Of Vasterbotten §, Sweden, 901 85
      • Recruiting
      • Department of Surgery
      • Contact: Karin Gustafsson, MD; Phone Number: +46 70 3364755; Email: karingustafsson@ymail.com
      • Principal Investigator: Karin Strigård, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasonography, abscess; The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.	Procedure: Perianal abscess drainage; 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.; Other Names: 1; Device: 3D ultrasonography; 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.; Other Names: 2
Other: Control group with clincial inscision; The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year.	Procedure: Perianal abscess drainage; 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.; Other Names: 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to one year

Collaborators and Investigators

• Sponsor: University Hospital, Umeå
• Investigators: Principal Investigator: Karin Gustafsson, MD, University Hospital, Umeå; Study Director: Karin Strigård Strigård, MD, University Hospital, Umeå; Study Chair: Ulf Gunnarsson, MD, University Hospital, Umeå

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimated): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: drainage; endoanal ultrasonography; perianal abscess; fistulas; incontience
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Suppuration; Intestinal Fistula; Digestive System Fistula; Fistula; Abscess; Rectal Fistula
• Other Study ID Numbers: 1-Gustafsson