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3D Endoanal Ultrasound and Anal Fistula (UFU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937752
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Region Skane

Study Description
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Brief Summary:
The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.

Condition or disease Intervention/treatment
Anal Fistula Other: 3D endodanal ultrasound

Study Design
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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of 3D Endoanal Ultrasound in Management of Anal Fistulas
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : March 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Ultrasound

Groups and Cohorts
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Group/Cohort Intervention/treatment
Anal fistula
Patients with anal fistulas, no previous fistula procedures. Ultrasound investigation done as a part of surgical treatment, such as loose seton or fistulotomy.
 Other: 3D endodanal ultrasound
Endoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure.
Other Name: 3D endoanal ultrasonography


Outcome Measures
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Primary Outcome Measures :
  1. Fistula position [ Time Frame: Day 1 ]
    Dorsal? Ventral? Lateral - right or left?

  2. Fistula level [ Time Frame: Day 1 ]
    Level I-IV (how much of the sphincter is affected?)

  3. Fistula length [ Time Frame: Day 1 ]
    Shorter or longer than 3 cm?


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed anal fistula with no previous anal fistula procedures.
Criteria

Inclusion Criteria:

  • anal fistula
  • no previous fistula procedures

Exclusion Criteria:

  • previous fistula procedures
  • ano/rectovaginal fistula
  • inflammatory bowel disease
  • more than one internal openings
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937752


Locations
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Sweden
Pelvic Floor Centre
Malmö, Sweden
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Ursula Aho Fält, MD Region Skane
More Information
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03937752    
Other Study ID Numbers: Ultrasound study 2018/201
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Region Skane:
anal fistula
fistula in ano
endoanal ultrasound
3D ultrasound
 3D ultrasonography
endoanal ultrasonography
diagnostics
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases