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NCT03937752 Clinical Trial

3D Endoanal Ultrasound and Anal Fistula

Anal Fistula Clinical Trial

— UFU  

Official title:
The Role of 3D Endoanal Ultrasound in Management of Anal Fistulas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03937752
Other study ID # Ultrasound study 2018/201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date January 24, 2023

Study information
Verified date February 2024
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 95
Est. completion date January 24, 2023
Est. primary completion date March 26, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• 3D endodanal ultrasound
Endoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure.

Locations
Country Name City State
Sweden Pelvic Floor Centre Malmö

Sponsors (1)
Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fistula position Dorsal? Ventral? Lateral - right or left? Day 1
Primary Fistula level Level I-IV (how much of the sphincter is affected?) Day 1
Primary Fistula length Shorter or longer than 3 cm? Day 1
See also
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Completed NCT04811105 - INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS N/A
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Recruiting NCT04616911 - Rerouting Seton Versus LIFT for Complex Anal Fistula N/A
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