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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

3D Endoanal Ultrasound and Anal Fistula

Clinicaltrials.gov identifier NCT03937752

Recruitment Status Completed

First Posted May 6, 2019

Last update posted March 30, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Anal Fistula
  • Intervention/Treatment: Other: 3D endodanal ultrasound
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2018
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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
  • 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
Contacts
Locations

Sweden
Pelvic Floor Centre
Malmö

Sponsors and Collaborators

Region Skane

Investigators

Principal Investigator: Ursula Aho Fält, MD Region Skane

More Information
  • Responsible Party: Region Skane
  • ClinicalTrials.gov Identifier: NCT03937752 History of Changes
  • 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
  • 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: Rectal Fistula Fistula