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NCT Number: NCT02306382

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.

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Key information

Conditions

Perianal Abscess Anal Fistulas Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Incontinence Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery

Umeå, County of Vasterbotten §, 901 85, Sweden

Location status: Recruiting

Location contact

Karin Gustafsson, MD

CONTACT

[email protected]

+46 70 3364755

Karin Strigård, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perianal abscess drainage

Procedure

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

3D ultrasonography

Device

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

Primary outcomes

  1. adverse events

    Time frame: up to one year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Strigård, MD

CONTACT

[email protected]

+46 785 5000

Ulf Gunnarsson, MD

CONTACT

[email protected]

+46 8 5177 0000

Sponsors and collaborators

Lead sponsor

University Hospital, Umeå

Other

Registry information

Official study title

Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.

Important dates

Study start
2012
Primary completion
2025
Study completion
2028
First posted
Dec 3, 2014
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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