3D Endoanal Ultrasound and Anal Fistula (UFU)

February 27, 2024 updated by: Region Skane

The Role of 3D Endoanal Ultrasound in Management of Anal Fistulas

The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Pelvic Floor Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed anal fistula with no previous anal fistula procedures.

Description

Inclusion Criteria:

  • anal fistula
  • no previous fistula procedures

Exclusion Criteria:

  • previous fistula procedures
  • ano/rectovaginal fistula
  • inflammatory bowel disease
  • more than one internal openings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 3D endoanal ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula position
Time Frame: Day 1
Dorsal? Ventral? Lateral - right or left?
Day 1
Fistula level
Time Frame: Day 1
Level I-IV (how much of the sphincter is affected?)
Day 1
Fistula length
Time Frame: Day 1
Shorter or longer than 3 cm?
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Ursula Aho Fält, MD, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

January 24, 2023

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultrasound study 2018/201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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